登记号 Registration number	CTR20211994	试验状态 Trial status	主动暂停 Active pause
申请人联系人 Applicant Contact	胡金凤 Hu Jinfeng	首次公示信息日期 The date on which the information was first published	2021-08-23
申请人名称 Name of applicant	Debiopharm International SA/ Farmea/ 杭州泰格医药科技股份有限公司/ 不适用/ 默克雪兰诺（北京）医药研发有限公司 Debiopharm International SA/ Farmea/ Hangzhou Tigermed Technology Co., Ltd. / N/A/ Merck Seronno (Beijing) Pharmaceutical R&D Co., Ltd

登记号 Registration number	CTR20211994
相关登记号 Relevant registration number
药物名称 The name of the drug	Xevinapant口服溶液   曾用名:  Xevinapant Oral Solution Previous Name:
药物类型 Type of medication	化学药物  Chemical drugs
临床申请受理号  Clinical application acceptance number	企业选择不公示  The company chooses not to make it public
适应症 Indications	局部晚期头颈部鳞状细胞癌 Locally advanced squamous cell carcinoma of the head and neck
试验专业题目 Experimental professional topics	一项在适合根治性放化疗的局部晚期头颈部鳞状细胞癌患者中评价Debio 1143联合含铂化疗和标准分次调强放疗的随机、双盲、安慰剂对照、III期研究（TrilynX） A Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Evaluate Debio 1143 in Combination With Platinum-Containing Chemotherapy and Standard Fractionated Intensity-Modulated Radiation Therapy in Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma Candidates Candidates for Radical Chemoradiotherapy (TrilynX)
试验通俗题目 Experiment with popular topics	Debio 1143联合含铂化疗和标准分次调强放疗的III期研究 A Phase III Study of Debio 1143 in Combination With Platinum-Containing Chemotherapy and Standard Fractionated Intensity-Modulated Radiotherapy
试验方案编号 Protocol number	Debio 1143-SCCHN-301	方案最新版本号  The latest version of the solution	Version 10.0
版本日期: Version Date:	2023-04-11	方案是否为联合用药 Whether the regimen is a combination of drugs	是

申请人名称 Name of applicant	1 2 3 4 5
联系人姓名 Contact name	胡金凤 Hu Jinfeng	联系人座机 Contact desk phone	010-59031594	联系人手机号 The contact's mobile phone number	13381139766
联系人Email Contact Email	jinfeng.hu@merckgroup.com	联系人邮政地址 Contact person postal address	北京市-北京市-朝阳区将台路甲2号诺金中心写字楼21层 21st Floor, NUO Center Office Building, No. 2A Jiangtai Road, Beijing-Chaoyang District, Beijing	联系人邮编 Contact zip code	100016

主要目的：在LA-SCCHN中证实在CRT的基础上添加Debio 1143相比于安慰剂的优效性。 次要目的：根据额外的有效性终点，评估在CRT基础上添加Debio 1143相比于安慰剂的有效性。评估在CRT基础上添加Debio 1143相比于安慰剂的安全性、耐受性和治疗依从性。使用患者自报结局问卷，评估在CRT基础上添加Debio 1143相比于安慰剂的健康相关生活质量。
Primary objective: To demonstrate the superiority of adding Debio 1143 to CRT compared to placebo in LA-SCCHN. Secondary Objectives: To evaluate the effectiveness of adding Debio 1143 to CRT compared to placebo based on additional efficacy endpoints. To assess the safety, tolerability, and treatment adherence of adding Debio 1143 to CRT compared to placebo. To assess health-related quality of life with the addition of Debio 1143 to CRT compared to placebo using a patient-reported outcome questionnaire.

试验分类 Classification of trials	安全性和有效性  Safety and efficacy	试验分期 Staging of the trial	III期  Stage III	设计类型 Type of design	平行分组  Parallel grouping
随机化 randomization	随机化  randomization	盲法 Blinding	双盲  Double-blind	试验范围 Scope of the test	国际多中心试验  International multicenter trial

年龄 age	18岁(最小年龄)至 无上限 (最大年龄)  18 years old (minimum age) to no upper limit (maximum age)
性别 gender	男+女  Male + Female
健康受试者 Healthy subjects	无
入选标准 Inclusion Criteria	1 在研究筛选前愿意并且能够提供知情同意书。  Willing and able to provide informed consent prior to study screening. 2 在签署知情同意书（ICF）之日，年龄≥18岁（或基于国家法定成人年龄限制）的男性或女性。 Male or female ≥ 18 years of age (or based on the national legal age limit of majority) on the date of signing the informed consent form (ICF). 3 美国东部肿瘤协作组体能状态（ECOG PS）评分为0或1。 Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1. 4 既往未经接受治疗，至少在以下一个部位有经组织学确诊且适合接受根治性CRT的LA-SCCHN（根据美国癌症联合会[AJCC]/TNM分期系统第8版，被确定为III、IVA或IVB期疾病）患者：口咽、下咽和喉部。注：如可能，将提供存档肿瘤样本（中国除外）。 Patients with previously untreated LA-SCCHN (identified as stage III, IVA, or IVB disease according to the American Cancer Federation [AJCC]/TNM staging system, 8th edition) who are histologically confirmed and suitable for radical CRT at at least one of the following sites: oropharynx, hypopharynx, and larynx. Note: Archival tumor samples will be provided if possible (except for China). 5 根据RECIST v1.1，通过计算机断层扫描或核磁共振成像评估的可评价肿瘤负荷（可测量和/或不可测量的肿瘤病灶）。 Evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography or magnetic resonance imaging according to RECIST v1.1. 6 对于OPC患者，使用免疫组化方法通过p16表达测定的原发肿瘤必须显示HPV阴性（应提供病理报告）。对于OPC 受试者，方案中定义了用于确定HPV 状态的 p16 临界值。 For OPC patients, primary tumors assayed by p16 expression using immunohistochemistry must be HPV-negative (pathology report should be provided). For OPC subjects, a p16 cut-off for determining HPV status is defined in the protocol. 7 能吞咽液体或具有功能充分的鼻饲管、胃造口或空肠造口。 Able to swallow liquids or have an adequately functioning nasogastric tube, gastrostomy, or jejunostomy. 8 临床评估显示无听力损失或≤ 2级听力受损（根据NCI-CTCAE v.5）。 Clinical assessment shows no hearing loss or ≤ grade 2 hearing loss (according to NCI-CTCAE v.5). 9 外周神经病变<2级。  Peripheral neuropathy < grade 2. 10 具有合格的血液学、肝肾功能，表现为：● 肾小球滤过率估计值≥ 60 mL/min/1.73m2（使用慢性肾病-流行病学协作组[CKD -EPI]肌酐公式计算）。 Have qualified hematological, hepatic and renal function, manifested as: ● Estimated glomerular filtration rate ≥ 60 mL/min/1.73m2 (calculated using the Chronic Kidney Disease-Epidemiology Collaborative Group [CKD-EPI] creatinine formula). 11 中性粒细胞绝对计数≥ 1 500个细胞/μL。血小板≥ 100 000个细胞/μL。血红蛋白≥ 9.0 g/dL（允许在筛选期间输血）。AST和ALT ≤ 3.0 ×正常值范围上限（ULN）。总胆红素≤ 1.5 × ULN（如果直接胆红素水平正常且升高仅限于间接胆红素，则允许直至2.0 × ULN）。 Absolute neutrophil count ≥ 1 500 cells/μL. Platelets≥ 100 000 cells/μL. Hemoglobin ≥ 9.0 g/dL (transfusions are allowed during screening). AST and ALT ≤ 3.0 × upper limit of normal range (ULN). Total bilirubin ≤ 1.5 × ULN (allowed up to 2.0 × ULN if direct bilirubin levels are normal and elevated is limited to indirect bilirubin). 12 有生育能力的女性（根据临床试验促进小组的建议）必须在筛选时血清妊娠检测结果呈阴性，并且不得进行母乳喂养。有生育能力的女性必须同意从签署ICF开始至最后一次化疗给药后6个月或最后一次Debio 1143/匹配安慰剂给药后3个月（以时间较晚者为准）期间采用高效避孕措施。 Females of childbearing potential (as recommended by the Clinical Trials Facilitation Group) must have a negative serum pregnancy test result at screening and must not be breastfeeding. Females of childbearing potential must agree to use highly effective contraception from the time of signing the ICF until 6 months after the last dose of chemotherapy or 3 months after the last dose of Debio 1143/matching placebo, whichever is later. 13 有性生活且女性伴侣有生育能力的非绝育男性必须同意从签署ICF开始至最后一次化疗给药后6个月或最后一次Debio 1143/匹配安慰剂给药后3个月（以时间较晚者为准）期间使用避孕套和杀精剂。由于男性避孕套和杀精剂并不是高效避孕措施，因此强烈建议男性研究受试者的女性伴侣在整个期间采用高效避孕措施（参见第8.1.3节）。 男性受试者在临床研究期间和最后一次化疗给药后6个月或最后一次Debio 1143/匹配安慰剂给药后3个月（以时间较晚者为准）期间必须避免捐精。如果先前未冷冻保存精子，建议有生育要求的男性患者在接受化疗或Debio 1143/匹配安慰剂给药之前冷冻保存精子。 Sexually active non-sterilized men with female partners of childbearing potential must agree to use condoms and spermicide from the time of signing the ICF until 6 months after the last dose of chemotherapy or 3 months after the last dose of Debio 1143/matching placebo, whichever is later. Because male condoms and spermicides are not highly effective contraception, it is strongly recommended that female partners of male study participants use highly effective contraception throughout the period (see Section 8.1.3). Male subjects must refrain from sperm donation during the clinical study and for 6 months after the last chemotherapy administration or 3 months after the last dose of Debio 1143/matching placebo, whichever is later. If sperm has not been previously crypreserved, it is recommended that male patients with fertility desires cryopreserve sperm prior to chemotherapy or Debio 1143/matching placebo administration.
排除标准 Exclusion Criteria:	1 鼻咽、鼻旁窦、鼻腔或口腔、唾液、甲状腺或甲状旁腺、皮肤的原发肿瘤或原发部位不明的肿瘤。 Primary tumors of the nasopharynx, paranasal sinuses, nasal cavity or oral cavity, saliva, thyroid or parathyroid glands, skin, or tumors of unknown primary site. 2 转移性疾病（根据第8版AJCC/TNM确定为IVC期）。 Metastatic disease (determined to be stage IVC according to the 8th edition of AJCC/TNM). 3 可能危害原发肿瘤放疗计划的既往针对头颈部区域进行的确定性或辅助性RT和/或根治性手术，或任何其他先前的SCCHN全身治疗（包括试验药物）。 Prior definitive or adjuvant RT and/or radical surgery for the head and neck region, or any other prior systemic therapy for SCCHN (including investigational agents) that could jeopardize the primary tumor radiotherapy program. 4 在随机分组前14天内使用或要求持续使用违禁药物清单上列出的任何药物治疗。 Use or request for continued use of any of the medications listed on the list of prohibited drugs within 14 days prior to randomization. 5 在研究治疗首次给药前4周内使用试验药物或试验器械治疗。 Treatment with an investigational drug or investigational device within 4 weeks prior to the first dose of study treatment. 6 已知的人类免疫缺陷病毒（HIV）感染病史。如果HIV病史未知，就需要进行HIV筛检，必须排除HIV-1/2血清学阳性的受试者。 Known history of human immunodeficiency virus (HIV) infection. If the history of HIV is unknown, HIV screening is indicated, and HIV-1/2 seropositive subjects must be excluded. 7 已知慢性活动性乙型肝炎病毒（HBV）或丙型肝炎病毒（HCV）感染。如果感染状态不明，应进行以下检查，必须排除血清学阳性的受试者： ● HBV筛检：HBVsAg和抗HepB核心IgG。 ● HCV筛检：通过PCR检测HCV抗体和HCV-RNA阳性病毒载量。 Known chronic active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. If the status of infection is unknown, the following tests should be performed, and subjects with positive serology must be excluded: ● HBV screening: HBVsAg and anti-HepB core IgG. ● HCV screening: Detect HCV antibody and HCV-RNA positive viral load by PCR. 8 其他需要全身治疗的感染（病毒和/或细菌和/或霉菌）。 Other infections (viruses and/or bacteria and/or molds) that require systemic treatment. 9 在首次试验治疗给药前30天内接种减毒活疫苗。  Administration of live attenuated vaccine within 30 days prior to the first dose of trial treatment. 10 在随机分组前1周内需要静脉注射抗生素治疗的持续未得到控制的感染。 Ongoing uncontrolled infections requiring intravenous antibiotic therapy within 1 week prior to randomization. 11 伴有临床确诊的吸收不良综合征的已知胃肠道疾病和可能限制口服吸收的重大胃肠外科手术。 Known gastrointestinal disease with clinically confirmed malabsorption syndrome and major gastrointestinal surgery that may limit oral absorption. 12 在随机分组前的最后4周内，记录到体重减轻>10%（除非采取适当的营养支持措施），或者血浆白蛋白< 3.0 g/dL。随机分组前2 周内不允许输注白蛋白。 In the last 4 weeks prior to randomization, a weight loss of >10% (unless appropriate nutritional support measures were taken) or a plasma albumin < 3.0 g/dL was recorded. Albumin infusion is not allowed within 2 weeks prior to randomization. 13 在随机分组前4周内，存在活动性胃肠道出血或需要2次以上红细胞输注或4单位浓缩红细胞输注的任何其他未受控制的出血。 Active gastrointestinal bleeding or any other uncontrolled bleeding requiring more than 2 red blood cell transfusions or 4 units of packed red blood cell transfusions within 4 weeks prior to randomization. 14 需要持续抗TNF药物治疗的活动性未受控制的炎症性疾病（包括类风湿关节炎、系统性红斑狼疮、Sj？gren综合征、重度全身广泛性银屑病和其他自身免疫性疾病）。 Active uncontrolled inflammatory disease requiring ongoing anti-TNF therapy (including rheumatoid arthritis, systemic lupus erythematosus, Sj?) Gren syndrome, severe generalized psoriasis, and other autoimmune diseases). 15 在开始治疗前7天内不能停用或使用安全替代药物替代的已知可延长QT间期的任何合并用药。 Any concomitant medication known to prolong the QT interval that cannot be discontinued or replaced with a safe alternative within 7 days prior to initiation of treatment. 16 心血管功能受损或具有临床意义的心血管疾病，包括下列任何一种： ● 当前存在未得到控制或有症状的缺血性心肌病或随机分组前6个月内存在该病史。 ● 已知的左心室射血分数<50%、左心室肥厚、室性心律失常、心动过缓（心率< 50 bpm）。 ● 随机分组前6个月内有心肌梗死或重度/不稳定心绞痛病史。 ● 纽约心脏协会≥ 3级充血性心力衰竭。 ● 先天性长QT综合征。 ● 长QT综合征家族史。 ● 随机分组前6个月内出现有症状的肺栓塞。 ● 持续中的短暂性脑缺血发作或卒中或已知随机分组前6个月内存在该病史。 ● 使用Fridericia公式的QTc间期（QTcF）：男性>450 ms、女性>470 ms。 Impaired cardiovascular function or clinically significant cardiovascular disease, including any of the following: ● Current presence of uncontrolled or symptomatic ischemic cardiomyopathy or history of this disease within 6 months prior to randomization. ● Known left ventricular ejection fraction <50%, left ventricular hypertrophy, ventricular arrhythmias, bradycardia (heart rate < 50 bpm). ● History of myocardial infarction or severe/unstable angina within 6 months prior to randomization. ● New York Heart Association ≥ Class 3 congestive heart failure. ● Congenital long QT syndrome. ● Family history of long QT syndrome. ● Symptomatic pulmonary embolism within 6 months prior to randomization. ● Ongoing transient ischemic attack or stroke or known history of this within 6 months prior to randomization. ● QTc interval (QTcF) using Fridericia's formula: 450 ms > for males and 470 ms for females >. 17 需要持续或间歇供氧的有症状的肺病。  Symptomatic lung disease requiring continuous or intermittent oxygen. 18 随机分组前3年内存在其他恶性肿瘤病史，不包括头颈部以外的完全切除的非黑色素瘤细胞皮肤癌或完全切除的I期乳腺癌，或完全切除的原位非肌肉浸润性膀胱、宫颈和/或子宫癌、或T1a 期食管鳞状细胞癌。 History of other malignancies within 3 years prior to randomization, excluding completely resected non-melanoma cell skin cancer other than the head and neck or completely resected stage I breast cancer, or completely resected orthotopic non-muscle invasive bladder, cervix, and/or uterine cancer, or stage T1a esophageal squamous cell carcinoma. 19 已知存在2-脱氧-2-[氟-18]氟代-D-葡萄糖正电子发射计算机断层扫描（18F-FDG-PET）、和/或造影剂增强MRI和造影剂增强CT扫描的禁忌症。 There are known contraindications to 2-deoxy-2-[fluoro-18]fluoro-D-glucose positron emission tomography (18F-FDG-PET), and/or contrast-enhanced MRI and contrast-enhanced CT scanning. 20 已知对Debio 1143、顺铂、卡铂、其他铂类药物或这些药物和安慰剂剂中已知的辅料存在过敏反应。 Known allergic reactions to Debio 1143, cisplatin, carboplatin, other platinum-based drugs, or known excipients in these drugs and placebo. 21 失代偿性或有症状的肝硬化（Child-Pugh评分：B或C） Decompensated or symptomatic cirrhosis (Child-Pugh score: B or C) 22 随机分组前持续存在的任何状况或疾病，包括药物滥用或酗酒，根据研究者的判断，这些状况或疾病会导致患者不适合入组研究或妨碍其遵守研究程序的能力。 Any condition or illness that persists prior to randomization, including substance abuse or alcoholism, that, in the judgment of the investigator, would make the patient unsuitable for enrollment in the study or preclude his or her ability to comply with study procedures.

试验药 Investigational drug

序号 serial number 名称 name 用法 usage 1 中文通用名:Debio 1143 口服溶液  Chinese common name: Debio 1143 oral solution 英文通用名:xevinapant oral solution 商品名称:NA   Product name: NA 剂型:口服溶液  Dosage form: oral solution 规格:20 mg/mL  Specification: 20 mg/mL 用法用量:将在6个周期内，在每个周期的第1天至第14天每日一次以200 mg/天的剂量给予Debio 1143口服溶液或匹配安慰剂 Dosage: Debio 1143 oral solution or matching placebo will be administered at a dose of 200 mg/day once daily on days 1 to 14 of each cycle over 6 cycles 用药时程:3周为一个周期   Duration of medication: 3 weeks as a cycle

对照药 Comparator

序号 serial number 名称 name 用法 usage 1 中文通用名:Debio 1143 口服溶液安慰剂 Chinese generic name: Debio 1143 oral solution placebo 英文通用名:Debio 1143 oral solution placebo Common name: Debio 1143 oral solution placebo 商品名称:NA   Product name: NA 剂型:口服溶液  Dosage form: oral solution 规格:0 mg/mL  Specification: 0 mg/mL 用法用量:将在6个周期内，在每个周期的第1天至第14天每日一次以200 mg/天的剂量给予Debio 1143口服溶液或匹配安慰剂 Dosage: Debio 1143 oral solution or matching placebo will be administered at a dose of 200 mg/day once daily on days 1 to 14 of each cycle over 6 cycles 用药时程:3周为一个周期   Duration of medication: 3 weeks as a cycle

主要终点指标及评价时间 The main endpoint indicators and evaluation time

序号 serial number 指标 index 评价时间 Evaluation time 终点指标选择 Endpoint metric selection 1 在LA-SCCHN中证实在CRT的基础上添加Debio 1143相比于安慰剂的优效性。 The superiority of adding Debio 1143 to CRT compared to placebo was demonstrated in LA-SCCHN. ● 任何原因导致的死亡。 ● 进展： ○ 影像学进展， ○ 临床进展。 ● 达到完全缓解（CR）前的初步治疗失败： ● 在实现CR后的任何影像学或临床复发（局部）, ● 第二种癌症. ● Death from any cause. ● Progression: ○ Imaging progress, ○ Clinical progress. ● Initial treatment failure prior to achieving complete response (CR): ● Any radiographic or clinical recurrence (local) after achieving CR, ● Second cancer. 有效性指标  Effectiveness metrics

次要终点指标及评价时间 Secondary endpoint measures and evaluation time

序号 serial number 指标 index 评价时间 Evaluation time 终点指标选择 Endpoint metric selection 1 根据额外的有效性终点，评估在CRT基础上添加Debio 1143相比于安慰剂的有效性。 To assess the effectiveness of adding Debio 1143 to CRT compared to placebo based on additional effectiveness endpoints. 无进展生存期（PFS），局部控制，客观缓解率，完全缓解率，缓解持续时间，总生存期，接受根治性挽救手术的受试者比例至后续全身性抗癌治疗的时间。 Progression-free survival (PFS), local control, objective response rate, complete response rate, duration of response, overall survival, proportion of subjects undergoing radical salvage surgery to the time of subsequent systemic anticancer therapy. 有效性指标  Effectiveness metrics 2 评估在CRT基础上添加Debio 1143相比于安慰剂的安全性、耐受性和治疗依从性。 To assess the safety, tolerability, and treatment adherence of adding Debio 1143 to CRT compared to placebo. ● 治疗持续时间 ● 周期数 ● 实际剂量 ● 剂量强度 ● 相对剂量强度 ● 治疗中断的发生率 ● 治疗减量的发生率 ● 治疗终止的发生率 ● Duration of treatment ● Number of cycles ● Actual dose ● Dose intensity ● Relative dose intensity ● Incidence of treatment interruption ● Incidence of treatment tapering ● Incidence of treatment discontinuation 有效性指标+安全性指标  Effectiveness index + safety index 3 使用患者自报结局问卷，评估在CRT基础上添加Debio 1143相比于安慰剂的健康相关生活质量。 To assess health-related quality of life with the addition of Debio 1143 to CRT compared to placebo using a patient-reported outcome questionnaire. ● 使用欧洲癌症研究与治疗组织（EORTC）QLQ-C30问卷评估的总体健康状态/生活质量和疲乏情况。 ● 使用EORTC QLQ-HN35问卷评估的吞咽和疼痛情况。 ● General health status/quality of life and fatigue as assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. ● Swallowing and pain as assessed using the EORTC QLQ-HN35 questionnaire. 安全性指标  Safety metrics

无 有

1	姓名 name	胡超苏 Hu Chaosu	学位 degree	博士 doctor	职称 job title	正高级 It is advanced
	电话 Phone	180 1731 2302	Email	hucsu62@163.com	邮政地址 Postal address	上海市-上海市-上海市东安路270号 Shanghai - Shanghai - Shanghai - No. 270 Dong'an Road, Shanghai
	邮编 Zip	201321	单位名称 The name of the organization	复旦大学附属肿瘤医药 Oncology medicine affiliated to Fudan University

序号 serial number	机构名称 Name of the institution	主要研究者 Principal Investigator	国家或地区 Country	省（州） Province (State)	城市 city
1	复旦大学附属肿瘤医药 Oncology medicine affiliated to Fudan University	胡超苏 Hu Chaosu	中国 China	上海市 Shanghai	上海市 Shanghai
2	华中科技大学同济医学院附属同济医院 Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology	胡广原 Hu Guangyuan	中国 China	湖北省 Hubei Province	武汉市 Wuhan
3	中南大学湘雅医院 Xiangya Hospital, Central South University	申良方 Shen Liangfang	中国 China	湖南省 Hunan Province	长沙市 Changsha city
4	辽宁省肿瘤医院 Liaoning Provincial Cancer Hospital	李霞 Li Xia	中国 China	辽宁省 Liaoning Province	沈阳市 Shenyang city
5	北京肿瘤医院 Beijing Cancer Hospital	孙艳 Sun Yan	中国 China	北京市 Beijing	北京市 Beijing
6	华中科技大学同济医学院附属协和医院 Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology	杨坤禹 Yang Kunyu	中国 China	湖北省 Hubei Province	武汉市 Wuhan
7	天津市肿瘤医院 Tianjin Cancer Hospital	王佩国 Wang Peiguo	中国 China	天津市 Tianjin City	天津市 Tianjin City
8	四川大学华西医院 West China Hospital, Sichuan University	王峰 Wang	中国 China	四川省 Sichuan Province	成都市 Chengdu City
9	广西医科大学附属肿瘤医院 Cancer Hospital Affiliated to Guangxi Medical University	曲颂 Song Song	中国 China	广西壮族自治区 Guangxi Zhuang Autonomous Region	南宁市 Nanning
10	上海交通大学附属第九人民医院 The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University	朱国培 Zhu Guopei	中国 China	上海市 Shanghai	上海市 Shanghai
11	汕头大学医学院附属肿瘤医院 Affiliated Cancer Hospital of Shantou University Medical College	林志雄 Lin Zhixiong	中国 China	广东省 Guangdong Province	汕头市 Shantou City
12	浙江省肿瘤医院 Zhejiang Provincial Cancer Hospital	陈晓钟 Chen Xiaozhong	中国 China	浙江省 Zhejiang Province	杭州市 Hangzhou City
13	哈尔滨医科大学附属肿瘤医院 Cancer Hospital Affiliated to Harbin Medical University	吴瑾 Wu Jin	中国 China	黑龙江省 Heilongjiang Province	哈尔滨市 Harbin City
14	河南省肿瘤医院 Henan Provincial Cancer Hospital	邱荣良 Qiu Rongliang	中国 China	河南省 Henan Province	郑州市 Zhengzhou City
15	福建省肿瘤医院 Fujian Provincial Cancer Hospital	林少俊 Lin Shaojun	中国 China	福建省 Fujian Province	福州市 Fuzhou City
16	湖南省肿瘤医院 Hunan Provincial Cancer Hospital	韩亚骞 Han Yaqian	中国 China	湖南省 Hunan Province	长沙市 Changsha city
17	浙江医科大学第二附属医院 The Second Affiliated Hospital of Zhejiang Medical University	魏启春 Wei Qichun	中国 China	浙江省 Zhejiang Province	杭州市 Hangzhou City
18	中山大学附属第五医院 The Fifth Affiliated Hospital of Sun Yat-sen University	王思阳 Wang Siyang	中国 China	广东省 Guangdong Province	广州市 Guangzhou City
19	孙逸仙纪念医院 Sun Yat-sen Memorial Hospital	黄晓明 Huang Xiaoming	中国 China	广东省 Guangdong Province	广州市 Guangzhou City
20	北京协和医院 Peking Union Medical College Hospital	贾宁 Jain	中国 China	北京市 Beijing	北京市 Beijing
21	吉林省肿瘤医院 Jilin Provincial Cancer Hospital	程颖 Cheng Ying	中国 China	吉林省 Jilin Province	长春市 Changchun city
22	临沂肿瘤医院 Linyi Cancer Hospital	石建华 Shi Jianhua	中国 China	山东省 Shandong Province	临沂市 Linyi City

序号 serial number	名称 name	审查结论 Conclusions of the review	批准日期/备案日期 Approval Date/Filing Date
1	复旦大学附属肿瘤医院医学伦理委员会 Medical Ethics Committee of Fudan University Cancer Hospital	修改后同意  Modified and agreed	2021-06-22
2	复旦大学附属肿瘤医院医学伦理委员会 Medical Ethics Committee of Fudan University Cancer Hospital	同意  agree	2021-12-21
3	复旦大学附属肿瘤医院医学伦理委员会 Medical Ethics Committee of Fudan University Cancer Hospital	同意  agree	2022-08-01
4	复旦大学附属肿瘤医院医学伦理委员会 Medical Ethics Committee of Fudan University Cancer Hospital	同意  agree	2022-11-14
5	复旦大学附属肿瘤医院医学伦理委员会 Medical Ethics Committee of Fudan University Cancer Hospital	同意  agree	2023-07-19

主动暂停 （鉴于研究药物和高剂量顺铂联合使用的潜在安全性风险考虑，IDMC建议在有充分的随访时间并允许在此情况下适当地进行获益-风险评估之前，不在计划的中国扩展队列中招募更多患者。申办方已于2023年3月22日通过公文向CDE 进行了报告，公文流水号为2023030336。）
Active Pause (Given the potential safety risk considerations of the combination of study drug and high-dose cisplatin, the IDMC recommends not enrolling additional patients in the planned China expansion cohort until there is sufficient follow-up time and allows for appropriate benefit-risk assessment in this setting.) The sponsor has reported to the CDE on March 22, 2023 through an official document with the serial number of 2023030336. ）

目标入组人数 Target enrollment	国内: 40 ； 国际: 875 ；  Domestic: 40 ; International: 875 ;
已入组人数 Number of people enrolled	国内: 49 ； 国际: 730 ；  Domestic: 49 ; International: 730 ;
实际入组总人数 The total number of people actually enrolled	国内: 49  ； 国际: 登记人暂未填写该信息； Domestic: 49 ; International: The registrant has not filled in this information yet;

第一例受试者签署知情同意书日期 The date on which the first subject signed the informed consent form	国内：2021-12-02；     国际：2020-08-26； Domestic:2021-12-02;     International: 2020-08-26;
第一例受试者入组日期 Date of enrollment of the first subject	国内：2022-02-13；     国际：2020-09-22； Domestic:2022-02-13;     International:2020-09-22;
试验暂停日期  The date the trial was suspended	国内：2023-03-08；     国际：登记人暂未填写该信息； Domestic:2023-03-08;     International: The registrant has not yet filled in this information;

序号 serial number	版本号 Version number	版本日期 Version date
暂未填写此信息 This information is not filled in yet