中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500101989
最近更新日期： Date of Last Refreshed on：	2025-05-07 09:05:43
注册时间： Date of Registration：	2025-05-07 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	艾伏尼布用于未经治疗或既往接受过1种系统性治疗方案的局部晚期或转移性经典型软骨肉瘤受试者
Public title：	Ivosidenib in participants with locally advanced or metastatic conventional chondrosarcoma untreated or previously treated with 1 systemic treatment regimen (CHONQUER study)
注册题目简写：
English Acronym：
研究课题的正式科学名称：	一项在携带 IDH1 突变、未经治疗或既往接受过1种系统性治疗方案的≥18岁局部晚期或转移性经典型软骨肉瘤受试者中评价艾伏尼布的 III 期、多中心、双盲、随机、安慰剂对照研究（CHONQUER研究）
Scientific title：	A Phase 3, multicenter, double-blind, randomized, placebo-controlled study of ivosidenib in participants >=18 years of age with locally advanced or metastatic conventional chondrosarcoma with an IDH1 mutation, untreated or previously treated with 1 systemic treatment regimen (CHONQUER study)
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	刘悦	研究负责人：	叶招明
Applicant：	Liu Yue	Study leader：	Ye Zhaoming
申请注册联系人电话： Applicant telephone：	+86 137 5208 8713	研究负责人电话： Study leader's telephone：	+86 571 87783777
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	yue.liu1@servier.com	研究负责人电子邮件： Study leader's E-mail：	yezhaominghz@163.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	北京市朝阳区东三环中路1号环球金融中心西楼6楼	研究负责人通讯地址：	浙江杭州市上城区解放路88号
Applicant address：	West Building, World Financial Center, No. 1 East Third Ring Middle Road, Chaoyang District, Beijing	Study leader's address：	No. 88 Jiefang Road, Shangcheng District, Hangzhou City, Zhejiang Province
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	施维雅（北京）医药研发有限公司
Applicant's institution：	Servier (Beijing) Pharmaceutical R&D Co., Ltd
研究负责人所在单位：	浙江大学医学院附属第二医院
Affiliation of the Leader：	The second affiliated hospital of Zhejiang University school of medicine

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	(2024)伦审药第(955)号	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	浙江大学医学院附属第二医院临床试验伦理审查委员会
Name of the ethic committee：	Human Research Ethics Committee,The Second Affiliated Hospital of Zhejiang University School of Medicine
伦理委员会批准日期： Date of approved by ethic committee：	2024-10-29 00:00:00
伦理委员会联系人：	王露
Contact Name of the ethic committee：	Wang Lu
伦理委员会联系地址：	浙江杭州市上城区解放路88号
Contact Address of the ethic committee：	No. 88 Jiefang Road, Shangcheng District, Hangzhou City, Zhejiang Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 571 87783508	伦理委员会联系人邮箱： Contact email of the ethic committee：	wanglu0130@zju.edu.cn

研究实施负责（组长）单位：

浙江大学医学院附属第二医院

Primary sponsor：

The second affiliated hospital of Zhejiang University school of medicine

研究实施负责（组长）单位地址：

浙江杭州市上城区解放路88号

Primary sponsor's address：

No. 88 Jiefang Road, Shangcheng District, Hangzhou City, Zhejiang Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	浙江省	市(区县)：
Country：	China	Province：	Zhejiang	City：
单位(医院)：	浙江大学医学院附属第二医院	具体地址：	浙江杭州市上城区解放路88号
Institution hospital：	The second affiliated hospital of Zhejiang University school of medicine	Address：	No. 88 Jiefang Road, Shangcheng District, Hangzhou City, Zhejiang Province

经费或物资来源：

施维雅（北京）医药研发有限公司

Source(s) of funding：

Servier (Beijing) Pharmaceutical R&D Co., Ltd

研究疾病：

软骨肉瘤

Target disease：

chondrosarcoma

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

III期临床试验

Study phase：

3

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

主要目的：基于 BICR 的肿瘤评估，评估艾伏尼布在1级和2级受试者中的疗效。关键次要目的：基于 BICR 的肿瘤评估，评估艾伏尼布在所有随机化受试者中的疗效；基于 OS 评估艾伏尼布的疗效。其他次要目的：评估艾伏尼布在1级和2级受试者以及所有随机化受试者中的额外疗效；评估艾伏尼布的安全性和耐受性；评估治疗对 HRQoL 和卫生经济学结果的影响；评价艾伏尼布的 PK 和 PD。探索性目的：对于从安慰剂交叉至艾伏尼布的受试者，评价从艾伏尼布首次给药至接受艾伏尼布后记录到的进展（由研究者评估）或全因死亡的时间（以先发生者为准）；识别可能提示临床缓解/耐药、PD活性和/或作用机制的探索性生物标志物。

Objectives of Study：

Primary Objective: To assess the efficacy of ivosidenib treatment based on tumor assessments by a BICR in Grade 1 and Grade 2 participants. Key Secondary Objectives: To assess the efficacy of ivosidenib treatment based on tumor assessments by a BICR in all randomized participants. To assess the efficacy of ivosidenib treatment based on OS. Other Secondary Objectives: To assess the additional efficacy of ivosidenib treatment in Grade 1 and Grade 2 participants and all randomized participants. To assess the safety and tolerability of treatment with ivosidenib. To assess the impact of treatment on HRQoL and health economic outcomes assessments. To evaluate the PK and PD of ivosidenib. Exploratory Objectives: To evaluate, for participants who crossover from placebo to ivosidenib, the time from first dose of ivosidenib to documented progression on ivosidenib, as assessed by the Investigator, or death due to any cause, whichever occurs first. To identify exploratory biomarkers that may be indicative of clinical response/resistance, PD activity, and/or the mechanism of action.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

1. 年龄≥18岁的男性或女性受试者。
2. ECOG PS 为0-1。允许纳入由于既往手术切除导致功能限制或由于肿瘤的解剖位置，导致ECOG PS 为2的受试者。
3. 愿意在研究治疗期间完成HRQoL（EORTC-QLQ-C30、EQ-5D-5L和PROMIS）评估。
4. 有生育能力的女性必须同意在开始 IMP 治疗前接受医学监督下的妊娠血液检查。首次妊娠试验将在筛选期间（IMP首次给药前7天内）进行，另一次在 IMP 首次给药当天进行，必须在给药前确认结果为阴性。 有生育能力的女性必须同意从签署知情同意书开始和研究治疗期间直至 IMP 末次给药后至少90天内禁欲或使用2种有效的避孕方法（高效方法和屏障法；均在附录7中描述）。单独使用激素避孕是不可接受的避孕方法，应与屏障法联合使用。 有生育能力的女性以及伴侣为有生育能力女性的有生育能力的男性必须同意从提供知情同意开始至整个研究期间以及 IMP 末次给药后90天内（女性和男性）使用2种有效的避孕方法（其中一种是高效方法，另一种是屏障方法）。研究期间和 IMP 末次给药后90天内不允许捐献精子。
5. 在进行方案第13.3节所述的任何研究特定程序前获得。受试者将签署预筛选和/或主知情同意书，具体取决于其 IDH1 突变检测的时间。
6. 组织病理学诊断（新鲜或在过去3年内采集的库存肿瘤活检样本）符合1、2或3级局部晚期或转移性经典型软骨肉瘤，且不适合根治性切除。
7. 根据RECIST v1.1定义，至少有一个 BICR 确认的可测量病灶。既往接受过放射治疗的受试者有资格参加研究，前提是可测量病灶在治疗区域外或在治疗区域内，并且自治疗后大小增加≥20%。
8. 针对软骨肉瘤，既往在晚期/转移性背景下接受过0-1种系统性治疗方案（发生转移性疾病复发/进展期间进行的辅助/维持/巩固治疗将被视为既往系统性治疗）。
9. 根据RECIST v1.1，受试者必须出现影像学进展/疾病复发，定义为： ● 随机化前12个月内间隔不超过6个月（±2周）进行的2次影像学评估证实了影像学疾病进展（局部和/或远处）。 或 ● 完成手术切除后任何疾病复发（局部和/或远处），并在随机化前6个月（±2周）内通过影像学检查证实。
10. 中心实验室检测记录为 IDH1 基因突变疾病（检测 R132C/L/G/H/S 突变变异体；见第9.1节）（来自新鲜肿瘤活检或可获得的最新库存肿瘤组织，其来自原发性或转移性肿瘤病灶）。
11. 具有充分的肾功能，定义为： ● 使用Cockcroft & Gault公式计算的肌酐清除率≥30 mL/min（附录4）；
12. 具有充分的肝功能，定义为： ● 血清总胆红素≤1.5×ULN（除非因Gilbert病认为必须≤3.0×ULN） ● 天门冬氨酸氨基转移酶 (AST)、丙氨酸氨基转移酶 (ALT) 和碱性磷酸酶 (ALP)≤2.5×ULN。对于骨转移和/或疾病相关肝脏受累的受试者，ALP必须≤5×ULN。
13. 具有充分的骨髓功能（血液检查前至少2周内未输血或使用生长因子）。 ● 中性粒细胞绝对计数≥1,500/mm^3 或1.5 × 10^9/L ● 血红蛋白≥8 g/dL ● 血小板≥75,000/mm^3 或75 × 10^9/L；
14. 从任何既往手术、放疗或预期用于治疗癌症的其他治疗的任何临床相关后遗症和毒性反应中恢复。

Inclusion criteria

1. Male or female participant aged >=18 years old.
2. ECOG PS of 0 to 1. Participants with an ECOG PS of 2 due to functional limitations as a result of prior surgical resections or due to the anatomical location of the tumor will be permitted.
3. Be willing to complete HRQoL (EORTC-QLQ-C30, EQ-5D-5L, and PROMIS) assessments during study treatment.
4. Women of childbearing potential must agree to undergo medically supervised pregnancy blood tests prior to starting the IMP. The first pregnancy test will be performed at Screening (within 7 days prior to the first IMP administration) and another on the day of the first IMP administration, the result of which must be confirmed negative prior to dosing. Women of childbearing potential must agree to abstain from sexual intercourse or use 2 effective methods of birth control (a highly effective method and a barrier method; both described in Appendix 7) from the time of giving informed consent and during study treatment until at least 90 days after the last dose of IMP. Hormonal contraception alone is not considered an acceptable method of contraception and should be combined with a barrier method. Women of childbearing potential, as well as fertile men with partners who are female with reproductive potential, must agree to use 2 effective forms of contraception (one of them a highly effective method and the other one a barrier method) from the time of giving informed consent throughout the study and for 90 days (both females and males) following the last dose of IMP. Sperm donation will not be allowed during the study and for 90 days after the last dose of IMP.
5. Obtained prior to any study-specific procedure as described in Section 13.3 of the protocol. Participants will sign a prescreening and/or main consent form depending on when their IDH1 mutation testing is performed.
6. Histopathological diagnosis (fresh or banked tumor biopsy sample, collected within the last 3 years) consistent with locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection.
7. At least one BICR-confirmed measurable lesion as defined by RECIST v1.1. Participants who have received prior radiation therapy are eligible provided measurable disease falls outside of the treatment field or within the field and has shown ≥20% growth in size since post-treatment assessment.
8. Received 0 to 1 prior systemic treatment regimen in the advanced/metastatic setting (adjuvant/maintenance/consolidation treatment during which metastatic disease recurrence/progression occurred will be considered as prior systemic treatment) for chondrosarcoma.
9. Participants must have radiographic progression/recurrence of disease according to RECIST v1.1 defined as: • Radiographic progression of disease (local and/or distant) documented by 2 imaging assessments performed no more than 6 months (+/-2 weeks) apart within 12 months before randomization. OR • Any recurrence of disease (local and/or distant) after complete surgical resection and documented by imaging within 6 months (+/-2 weeks) before randomization.
10. Documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the most recent banked tumor tissue available that was sourced from either a primary or metastatic tumor lesion) based on central laboratory testing (R132C/L/G/H/S mutation variants tested; see Section 9.1).
11. Adequate renal function defined as: • Creatinine clearance >=30 mL/min, based on using the Cockcroft & Gault formula (Appendix 4);
12. Adequate hepatic function defined as: • Total serum bilirubin <=1.5 × ULN (unless considered due to Gilbert disease where it must be <= 3.0 × ULN.) • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) <=2.5 × ULN. For participants with bone metastases and/or disease-related hepatic involvement, ALP must be <=5 × ULN.
13. Adequate bone marrow function without transfusions or growth factors for at least 2 weeks prior to the blood test. • Absolute neutrophil count >=1,500/mm^3 or 1.5 × 10^9/L • Hemoglobin >=8 g/dL • Platelets >=75,000/mm^3 or 75 × 10^9/L;
14. Recovered from any clinically relevant sequelae and toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer.

排除标准：

1. 无法吞咽口服药物。 2. 妊娠或哺乳期女性。 3. 不能配合研究。 4. 同时参加另一项干预性研究；允许参加非干预性登记研究或流行病学研究。 5. 受试者已入组研究（签署知情同意书）并已接受至少一剂IMP。 6. 既往接受过 IDH1 抑制剂治疗。 7. 随机化前 < 2周内接受过系统性抗癌治疗（既往研究性或基于免疫的抗癌治疗的洗脱期为4周）。 8. 随机化前 < 2周内接受过放疗。 9. 已知有症状性脑部转移，需要剂量为 > 10 mg/天泼尼松（或换算剂量）的类固醇治疗。既往诊断为脑部转移的受试者如果在随机化前已完成治疗且已从放射治疗或手术的急性反应中恢复，因这些转移中止或降低皮质类固醇剂量至≤10 mg/天至少4周，并且在随机化前脑病灶达到放射学疾病稳定至少3个月，则有资格参加研究。 10. 有其他原发性癌症病史，以下除外：a）已根治性切除的非黑色素瘤皮肤癌；b）已治愈的原位癌；或c）pT1-2前列腺癌 Gleason 评分 < 6；或d）受试者在开始研究治疗前≥1年内无其他原发性实体瘤或液体肿瘤，并且研究者认为在当前诊断为软骨肉瘤的情况下，该疾病不会影响受试者的结局。 11. 随机化前4周内接受过大手术。 12. 正在使用治疗窗窄的已知强效细胞色素 P450 (CYP) 3A4 诱导剂或敏感的 CYP3A4 底物药物，除非（至少经过5个半衰期后）在随机化前将其转换为其他药物。 13. 在随机化前7天内有需要系统性抗感染治疗的活动性感染或不明原因的发热 > 38.5℃（根据研究者的判断，肿瘤热受试者可入组）。 14. 已知对艾伏尼布或匹配安慰剂的任何成分过敏。 15. 随机化前6个月内有显著的活动性心脏疾病，包括纽约心脏协会 (NYHA) III 级或 IV 级充血性心力衰竭、心肌梗死、不稳定型心绞痛和/或卒中。 16. 随机化前28天内通过 ECHO 扫描（或根据机构实践的其他方法）获得的LVEF < 40%。 17. 心率校正的 QT 间期（使用 Fridericia 公式）(QTcF) ≥450 ms或具有增加 QT 间期延长或心律失常事件风险的其他因素（例如，心力衰竭、低钾血症、长 QT 综合征家族史）。根据当地心脏病学评估，允许束支阻滞合并 QTcF 间期延长的受试者入组。 18. 正在使用已知可延长 QT 间期的药物，除非（至少经过5个半衰期后）在随机化前将其转换为其他药物，或者除非可以在研究期间对药物进行适当监测。如果无等效药物，应密切监测QTcF。 19. 已知有活动性乙型肝炎 (HBV) 或丙型肝炎 (HCV) 感染、已知 HIV 抗体结果阳性或 AIDS 相关疾病。允许对 HCV 治疗有持续性病毒应答或对既往 HBV 感染有免疫力的受试者入组。根据机构实践，允许慢性 HBV 或 HIV 得到充分抑制的受试者入组。 20. 患有任何其他急性或慢性医学或精神疾病，包括近期（过去12个月内）或主动自杀意念或行为，或可能会增加与参加研究或 IMP 给药相关的风险，或可能干扰研究结果判定和（根据研究者判断）可能使受试者不适合参加本研究的实验室检查异常。 21. 已知患有活动性炎性胃肠道疾病、慢性腹泻、既往胃切除术或胃束带成形术、吞咽困难、短肠综合征、胃轻瘫或其他限制口服给药药物摄入或胃肠道吸收的疾病。允许存在正在接受药物治疗的胃食管反流病（假设无潜在药物相互作用）。 22. 已知有进行性多灶性脑白质病 (PML) 病史。

Exclusion criteria：

1. Unable to swallow oral medication. 2. Pregnant or lactating women. 3. Unlikely to cooperate in the study. 4. Participating in another interventional study at the same time; participation in noninterventional registries or epidemiological studies is allowed. 5. Participant already enrolled in the study (informed consent signed) and had received at least one dose of IMP. 6. Prior therapy with an IDH1 inhibitor. 7. Received systemic anticancer therapy <2 weeks prior to randomization (washout from prior investigational or immune-based anticancer therapy is 4 weeks). 8. Received radiotherapy <2 weeks prior to randomization. 9. Have known symptomatic brain metastases requiring steroids >10 mg per day prednisone (or equivalent). Participants with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to randomization, have discontinued or reduced corticosteroid treatment to <=10 mg per day for these metastases for at least 4 weeks and have radiographically stable disease of brain lesions for at least 3 months prior to randomization. 10. Have a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated carcinoma in situ; or c) pT1-2 prostatic cancer Gleason score <6 or d) participant is free of other primary solid or liquid tumor for >=1 year prior to the start of study treatment and, in the opinion of the Investigator, the disease will not affect participant’s outcome in the setting of current chondrosarcoma diagnosis. 11. Major surgery within 4 weeks prior to randomization. 12. Are taking known strong cytochrome P450 (CYP) 3A4 inducers or sensitive CYP3A4 substrate medications with a narrow therapeutic window, unless (after at least 5 half-lives have elapsed) they can be transferred to other medications prior to randomization. 13. Have an active infection requiring systemic anti-infective therapy or with an unexplained fever >38.5°C within 7 days prior to randomization (at the discretion of the Investigator, participants with tumor fever may be enrolled). 14. Have any known hypersensitivity to any of the components of ivosidenib or the matched placebo. 15. Have significant active cardiac disease within 6 months prior to randomization, including New York Heart Association (NYHA) Class III or IV congestive heart failure; myocardial infarction; unstable angina; and/or stroke. 16. Have LVEF <40% by ECHO scan (or by other methods according to institutional practice) obtained within 28 days prior to randomization. 17. Have a heart-rate corrected QT interval (using Fridericia’s formula) (QTcF) >= 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events (eg, heart failure, hypokalemia, family history of long QT interval syndrome. Participants with a bundle branch block combined with a prolonged QTcF interval may be permitted based on local cardiology assessment. 18. Are taking medications that are known to prolong the QT interval unless (after at least 5 half-lives have elapsed) they can be transferred to other medications prior to randomization or unless the medications can be properly monitored during the study. If equivalent medication is not available, QTcF should be closely monitored. 19. Have known active hepatitis B (HBV) or hepatitis C (HCV) infections, known positive HIV antibody results, or AIDS-related illness. Participants with a sustained viral response to HCV treatment or immunity to prior HBV infection will be permitted. Participants with chronic HBV or HIV that are adequately suppressed per institutional practice will be permitted. 20. Have any other acute or chronic medical or psychiatric condition, including recent (within last 12 months) or active suicidal ideation or behavior, or a laboratory abnormality that may increase the risk associated with study participation or IMP administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the participant inappropriate for entry into this study. 21. Have known active inflammatory gastrointestinal disease, chronic diarrhea, previous gastric resection or lap band, dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally. Gastroesophageal reflux disease under medical treatment is allowed (assuming no drug interaction potential). 22. Have known medical history of progressive multifocal leukoencephalopathy (PML).

研究实施时间：

Study execute time：

从 From 2025-06-30 00:00:00至 To 2031-06-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-06-30 00:00:00 至 To 2026-11-07 00:00:00

干预措施：

Interventions：

组别：	安慰剂组	样本量：	68
Group：	placebo group	Sample size：	68
干预措施：	安慰剂	干预措施代码：
Intervention：	placebo	Intervention code：

组别：	艾伏尼布组	样本量：	68
Group：	ivosidenib group	Sample size：	68
干预措施：	艾伏尼布	干预措施代码：
Intervention：	ivosidenib	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	浙江	市(区县)：
Country：	China	Province：	Zhejiang	City：
单位(医院)：	浙江大学医学院附属第二医院	单位级别：	三级甲等
Institution hospital：	The second affiliated hospital of Zhejiang University school of medicine	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	四川	市(区县)：
Country：	China	Province：	Sichuan	City：
单位(医院)：	四川大学华西医院	单位级别：	三级甲等
Institution hospital：	West China Hospital of Sichuan University	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海交通大学医学院附属瑞金医院	单位级别：	三级甲等
Institution hospital：	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	广东	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	中山大学肿瘤防治中心	单位级别：	三级甲等
Institution hospital：	Sun Yat-sen University Cancer Center	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海市第一人民医院	单位级别：	三级甲等
Institution hospital：	Shanghai General Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	首都医科大学附属北京积水潭医院	单位级别：	三级甲等
Institution hospital：	Beijing Jishuitan Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	广东	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	中山大学附属第一医院	单位级别：	三级甲等
Institution hospital：	The First Affiliated Hospital,Sun Yat-sen University	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	北京肿瘤医院（北京大学肿瘤医院）	单位级别：	三级甲等
Institution hospital：	Beijing Cancer Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	河南	市(区县)：
Country：	China	Province：	Henan	City：
单位(医院)：	河南省肿瘤医院	单位级别：	三级甲等
Institution hospital：	Henan Cancer Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	湖南	市(区县)：
Country：	China	Province：	Hunan	City：
单位(医院)：	湖南省肿瘤医院	单位级别：	三级甲等
Institution hospital：	Hunan Cancer Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	湖北	市(区县)：
Country：	China	Province：	Hubei	City：
单位(医院)：	华中科技大学同济医学院附属协和医院	单位级别：	三级甲等
Institution hospital：	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	1级和2级受试者的无进展生存期	指标类型：	主要指标
Outcome：	Progression free survival of level 1 and level 2 subjects	Type：	Primary indicator
测量时间点：		测量方法：	CT 扫描或 MRI 或 PET-CT 扫描
Measure time point of outcome：		Measure method：	Extent of disease will be assessed based on RECIST v1.1. Response assessments will be conducted at 4 weeks (C2D1) ±7 days, then every 8 weeks (±7 days) for the next 12 assessments through Week 100, then every 12 weeks (±7 days) for the next 9 assessments through Week 208, and then every 24 weeks (±7 days) thereafter until withdrawal of consent, BICR-confirmed disease progression, death, the participant is lost to follow-up, or until the end of study/study termination

指标中文名：	1级和2级受试者的总生存期	指标类型：	次要指标
Outcome：	Overall survival of level 1 and level 2 subjects	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	缓解持续时间	指标类型：	次要指标
Outcome：	Duration of relief	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	血液	组织：
Sample Name：	blood	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age		岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

研究者或授权人员通过 RTSM 管理随机化和/或治疗分配（包括剂量调整）。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The randomization and/or the treatment allocation (including dose adjustment) will be managed through RTSM by the Investigator or authorized person.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：	双盲
Blinding：	Double blind

是否共享原始数据： IPD sharing	是Yes
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	本研究采取EDC系统采集研究数据，EDC系统名称为C1。网址：https://servier.clinicalone.oraclecloud.com/eclinical-portal/?ojr=clinicalone%2Fruntime%3BisLibraryStudy%3D0%3Bmode%3Dactive%3BreadOnly%3D%3BstudyId%3D09D2173EE3CD4CB8B40187C9B6C9F044%3Btype%3D%3BversionId%3D2.4.0.100%2Fsupplies
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	The data were collected by the EDC system, the name of the EDC system is C1. Website: https://servier.clinicalone.oraclecloud.com/eclinical-portal/?ojr=clinicalone%2Fruntime%3BisLibraryStudy%3D0%3Bmode%3Dactive%3BreadOnly%3D%3BstudyId%3D09D2173EE3CD4CB8B40187C9B6C9F044%3Btype%3D%3BversionId%3D2.4.0.100%2Fsupplies
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	电子采集和管理系统（EDC）
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	EDC
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2025-05-07 09:05:23