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：	ChiCTR2500112018
最近更新日期： Date of Last Refreshed on：	2025-11-10 08:12:35
注册时间： Date of Registration：	2025-11-10 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	探索卡度尼利单抗联合同步放化疗在局晚期宫颈癌治疗中的有效性与安全性
Public title：	Cadonilimab with chemoradiotherapy for newly diagnosed locally advanced cervical cancer
注册题目简写：
English Acronym：
研究课题的正式科学名称：	探索卡度尼利单抗联合同步放化疗在局晚期宫颈癌治疗中的有效性与安全性
Scientific title：	Cadonilimab with chemoradiotherapy for newly diagnosed locally advanced cervical cancer
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：	陈忠杰	研究负责人：	陈忠杰
Applicant：	Chen Zhongjie	Study leader：	Chen Zhongjie
申请注册联系人电话： Applicant telephone：	+86 186 2222 8638	研究负责人电话： Study leader's telephone：	+86 186 2222 8638
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：	zchen01@tmu.edu.cn	研究负责人电子邮件： Study leader's E-mail：	zchen01@tmu.edu.cn
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：	天津市空港经济区东五道 99 号天津市肿瘤医院空港医院	研究负责人通讯地址：	天津市空港经济区东五道 99 号天津市肿瘤医院空港医院
Applicant address：	Tianjin Cancer Hospital Airport Hospital	Study leader's address：	Tianjin Cancer Hospital Airport Hospital
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：	天津市肿瘤医院空港医院
Applicant's institution：	Tianjin Cancer Hospital Airport Hospital
研究负责人所在单位：	天津市肿瘤医院空港医院
Affiliation of the Leader：	Tianjin Cancer Hospital Airport Hospital

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：	EC-2024-0036	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：	天津市肿瘤医院空港医院医学伦理委员会
Name of the ethic committee：	Tianjin Cancer Hospital Airport Hospital Medical Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	2024-05-23 00:00:00
伦理委员会联系人：	陈璐
Contact Name of the ethic committee：	Chen Lu
伦理委员会联系地址：	天津市空港经济区东五道 99 号 2 楼(300308)
Contact Address of the ethic committee：	2F, No. 99 Dongwu Road, Airport Economic Zone, Tianjin 300308, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 22 6067 0123	伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

天津市肿瘤医院空港医院

Primary sponsor：

Tianjin Cancer Hospital Airport Hospital

研究实施负责（组长）单位地址：

天津市空港经济区东五道 99 号

Primary sponsor's address：

No. 99 Dongwu Road, Airport Economic Zone, Tianjin 300308, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	天津市	市(区县)：
Country：	China	Province：	Tianjin	City：
单位(医院)：	天津市肿瘤医院空港医院	具体地址：	天津市空港经济区东五道 99 号
Institution hospital：	Tianjin Cancer Hospital Airport Hospital	Address：	No. 99 Dongwu Road, Airport Economic Zone, Tianjin 300308, China

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

宫颈癌

Target disease：

Cervical cancer

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：

II期临床试验

Study phase：

2

研究设计：

单臂

Study design：

Single arm

研究目的：

主要目的评估卡度尼利单抗联合同步放化疗治疗局部晚期宫颈癌患者的有效性。次要目的评估卡度尼利单抗联合同步放化疗治疗局部晚期宫颈癌患者的安全性。

Objectives of Study：

Primary objective To evaluate the efficacy of cadunilumab in combination with concurrent chemoradiotherapy for patients with locally advanced cervical cancer. Secondary objective To evaluate the safety of cadunilumab in combination with concurrent chemoradiotherapy for patients with locally advanced cervical cancer.

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.受试者能够理解并自愿签署书面知情同意书。知情同意书必须在执行研究要求的指定研究程序前签署。
2.在签署知情同意书当日年龄>= 18 岁，女性。
3.东部肿瘤协作组织（ECOG）体能状况评分为0 或1。
4.预期生存期>=6 个月。
5.经组织学或细胞学确诊的宫颈癌。
5.1病理类型为鳞癌；
5.2未经任何抗肿瘤治疗（包括但不限于放疗、化疗、手术、靶向治疗和免疫治疗）。
注：以临床分期为目的进行的盆腔淋巴结或主动脉旁淋巴结切除或活检是允许的。
5.3FIGO2018 分期在ⅢA-ⅣA 期，如诊断ⅢC1 期，需要有>=2 个确认转移的淋巴结。
淋巴结转移诊断可经活检证实或影像学诊断；影像学诊断淋巴结转移需满足下列任一标准：
MRI 或CT 显示阳性淋巴结（最小横径>=10mm），需注意最小横径需>=15mm 方可作为靶病灶。18F-FDG PET/CT 提示阳性淋巴结（SUVmax>=2.5）
6.根据RECIST v1.1 标准至少有一个可测量肿瘤病灶。
7.所有受试者必须愿意在随机前提供肿瘤组织样本。
8. 具有良好的器官功能：
8.1 血液学（开始研究治疗前7天内未使用任何血液成分及细胞生长因子支持治疗）：中性粒细胞绝对值ANC >=1.5 ×10^9/L (1,500/mm^3) ； 血小板计数 >= 100 × 10^9/L (100,000/mm^3) ； 血红蛋白 >= 90 g/L。
8.2 肾脏：肌酐清除率* (CrCl) 计算值 >= 50 mL/min。* 将采用 Cockcroft-Gault 公式计算CrCl (Cockcroft-Gault 公式) CrCl (mL/min) = {(140 - 年龄) × 体重 (kg) × 0.85}/ (血清肌酐. (mg/dL) × 72)。尿蛋白 < 2+ 或24小时（h）尿蛋白定量 < 1.0 g。
8.3 肝脏：血清总胆红素（TBil）<= 1.5 × ULN；AST和ALT <= 2.5× ULN；血清白蛋白（ALB）>=28 g/L
8.4 凝血功能：国际标准化比率（INR）和活化部分凝血活酶时间（APTT）<= 1.5 × ULN（如受试者正在接受抗凝治疗，则受试者须接受稳定剂量抗凝剂且在筛选时凝血参数（PT/INR 和APTT）处在使用抗凝剂治疗的预期范围内）。
8.5 心功能：左室射血分数（LVEF）>= 50%。
9. 具有生育能力的女性受试者必须在首次用药前3天内进行尿液或血清妊娠检查（如尿液妊娠检查结果不能确认为阴性，需进行血清妊娠检查，以血清妊娠结果为准），且结果为阴性。如具有生育能力的女性受试者与未绝育的男性伴侣发生性行为，该受试者必须自筛选开始采取可接受的避孕方法，且必须同意在研究药物末次用药后的120天内持续使用采用避孕方法；关于在此时间点后是否停止避孕，应与研究者讨论。周期性禁欲、安全期避孕是不可接受的避孕方法。有生育能力的女性是指未经手术绝育（即双侧输卵管结扎术、双侧卵巢切除术或全子宫切除术）或未绝经的女性（绝经的定义为无替代医学原因的前提下至少连续12个月停经，血清促卵泡激素水平在绝经后女性的实验室参考范围之内）；高效的避孕方法是指在持续正确使用情况下避孕失败率很低（如每年低于 1%）的避孕方法。并非所有避孕方法均是高效的。除屏障避孕法之外，有生育能力的女性受试者还必须单独使用激素避孕法（如避孕药），以确保不发生妊娠。
10.	受试者愿意而且能够遵守日程表规定的访视、治疗方案、实验室检查，及遵守研究的其他要求。

Inclusion criteria

1. Subjects are able to understand and voluntarily sign a written informed consent. The informed consent must be signed before the specified research procedures required by the study are performed.
2. Aged >= 18 years old and female on the day of signing the informed consent.
3. Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1.
4. Expected survival period is >= 6 months.
5. Cervical cancer confirmed by histology or cytology.
5.1 Pathological type is squamous cell carcinoma;
5.2 No anti-tumor treatment (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy and immunotherapy) has been received.
Note: Pelvic lymph node or para-aortic lymph node resection or biopsy for the purpose of clinical staging is allowed.
5.3 FIGO2018 stage is ⅢA-ⅣA. If diagnosed with stage ⅢC1, there must be >=2 confirmed metastatic lymph nodes.
Lymph node metastasis can be diagnosed by biopsy or imaging; imaging diagnosis of lymph node metastasis must meet any of the following criteria:
MRI or CT shows positive lymph nodes (minimum transverse diameter >= 10mm), and it should be noted that the minimum transverse diameter must be >= 15mm to be used as a target lesion. 18F-FDG PET/CT indicates positive lymph nodes (SUVmax >= 2.5)
6. At least one measurable tumor lesion according to RECIST v1.1 standards.
7. All subjects must be willing to provide tumor tissue samples before randomization.
8. Good organ function:
8.1 Hematology (no blood components and cell growth factor support therapy were used within 7 days before the start of study treatment): absolute neutrophil ANC >= 1.5 × 10^9/L (1,500/mm^3); platelet count >= 100 × 10^9/L (100,000/mm^3); hemoglobin >= 90 g/L.
8.2 Kidney: Calculated creatinine clearance* (CrCl) >= 50 mL/min. * CrCl will be calculated using the Cockcroft-Gault formula (Cockcroft-Gault formula) CrCl (mL/min) = {(140 - age) × body weight (kg) × 0.85}/ (serum creatinine. (mg/dL) × 72). Urine protein < 2+ or 24-hour (h) urine protein < 1.0 g.
8.3 Liver: serum total bilirubin (TBil) <= 1.5 × ULN; AST and ALT <= 2.5 × ULN; serum albumin (ALB) >= 28 g/L
8.4 Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (APTT) <= 1.5 × ULN (if the subject is receiving anticoagulant therapy, the subject must receive a stable dose of anticoagulants and the coagulation parameters (PT/INR and APTT) are within the expected range of anticoagulant therapy at screening).
8.5 Cardiac function: left ventricular ejection fraction (LVEF) >= 50%.
9. Female subjects of childbearing potential must undergo a urine or serum pregnancy test within 3 days before the first medication (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test is required, and the serum pregnancy result shall prevail), and the result must be negative. If a female subject of childbearing potential has sexual intercourse with a male partner who is not sterilized, the subject must use an acceptable contraceptive method from the start of screening and must agree to continue using the contraceptive method within 120 days after the last dose of the study drug; whether to stop contraception after this time point should be discussed with the investigator. Cyclic abstinence and safe period contraception are unacceptable contraceptive methods. Women of childbearing potential refer to those who have not undergone surgical sterilization (i.e. bilateral tubal ligation, bilateral oophorectomy, or total hysterectomy) or premenopausal women (menopause is defined as at least 12 consecutive months of amenorrhea without alternative medical reasons, and serum follicle-stimulating hormone levels are within the laboratory reference range for postmenopausal women); highly effective contraceptive methods refer to contraceptive methods with a very low contraceptive failure rate (e.g., less than 1% per year) when used continuously and correctly. Not all contraceptive methods are highly effective. In addition to barrier contraception, female subjects of childbearing potential must also use hormonal contraception (e.g., birth control pills) alone to ensure that pregnancy does not occur.
10. The subject is willing and able to comply with the scheduled visits, treatment regimen, laboratory tests, and other requirements of the study.

排除标准：

1.其他病理组织学类型的宫颈癌受试者，如神经内分泌癌、肉瘤等。 2.有远处转移证据，包括腹股沟淋巴结转移及近头侧L1 椎体上缘水平以上淋巴结转移。 3.曾接受全子宫切除术（切除子宫体+子宫颈）。次全子宫切除术或宫角切除术等保留宫颈的手术史是允许的。 4.因解剖异常等原因无法使用近距离放疗拒绝接受近距离放疗。 5.留置金属宫内节育器不能进行MRI 成像。 6.随机前2 年内患有其他活动性恶性肿瘤，除局部可治愈的瘤种且表现为已治愈者外，如皮肤鳞状细胞癌、皮肤基底细胞癌、浅表性膀胱癌、乳腺原位癌。 7.存在具有临床意义的双侧肾盂积水，经研究者判断不能经肾造瘘术或输尿管支架置入术缓解。 8.既往接受过免疫检查点抑制剂（如：抗PD-1 抗体、抗PD-L1 抗体、抗CTLA-4抗体等）或针对免疫共刺激因子（如：针对ICOS、CD40、CD137、GITR、OX40靶点的抗体等）等任何针对肿瘤免疫作用机制的治疗。 9.随机前2 周内需要使用糖皮质激素（> 10 mg/日泼尼松或等效剂量的糖皮质激素）或其他免疫抑制药物进行全身治疗的受试者；以下除外： a) 允许吸入性、眼科或局部使用剂量<= 10 mg/日泼尼松或等效剂量的糖皮质激素治疗。 b) 生理性糖皮质激素替代治疗，用量<= 10 mg/日泼尼松或等效剂量的糖皮质激素。 c) 糖皮质激素作为超敏反应的预防用药（如CT 检查前用药）。随机前2 周内接受过具有免疫调剂作用的药物（如胸腺肽、干扰素、白介素-2） 10.随机前2 周内接受过具有免疫调剂作用的药物（如胸腺肽、干扰素、白介素-2）。 11.存在需要全身系统治疗的活动性感染（包括活动性肺结核、活动性梅毒螺旋体感染以及需要全身系统治疗的真菌感染），注：针对乙型病毒性肝炎而使用的抗病毒药物除外。 12.随机前4 周内发生严重感染，包括但不局限于伴有需要住院治疗的并发症、败血症或严重肺炎。 13.随机前4 周内接受过重大手术治疗（由研究者确定），开放性活检或出现过显著外伤；或研究期间需要进行择期的重大手术治疗。以诊断为目的的系统性盆腔/主动脉旁淋巴切除术是允许的。 14.随机前4 周内使用过活疫苗。 15.患有活动性或可能复发的自身免疫性疾病；以下除外：不需系统治疗的白癜风、脱发、银屑病或湿疹；由自身免疫性甲状腺炎引起的甲状腺功能减退，仅需要稳定剂量的激素替代治疗；仅需要稳定剂量的胰岛素替代治疗的I 型糖尿病。下列任何心脑血管疾病： a) 经充分抗高血压药物治疗仍无法控制的高血压（定义为收缩压>150 mmHg，舒张压>100 mmHg），或有发生高血压危象，高血压脑病的病史； b) 随机前6 个月内发生心肌梗死、不稳定性心绞痛、肺栓塞、主动脉夹层、深静脉血栓及任何动脉血栓栓塞事件； c) 美国纽约心脏病协会（NYHA）心功能分级>= II 级的心力衰竭； d) 存在需要长期药物干预的严重心律失常；允许入组无症状、心室率稳定的心房颤动患者； e) 随机前6 个月内发生脑血管事件（CVA）； f) 左室射血分数（LVEF）< 50%； g) 既往患有心肌炎或心肌病病史。 16.已知原发性或继发性免疫缺陷，包括人类免疫缺陷病毒（HIV）抗体检测阳性。 17.活动性乙型病毒性肝炎受试者，非活动性或无症状的乙型肝炎病毒（HBV）携带者（乙型肝炎表面抗原[HBsAg]阳性）且HBV DNA＞1000 IU/mL，及活动性丙型病毒性肝炎受试者。注：非活动性或无症状的携带者，经治疗且稳定的乙型肝炎受试者符合HBV DNA<= 1000 IU/mL 允许入组。已治愈的丙型病毒性肝炎受试者，HCVAb 阳性且HCVRNA 阴性的受试者允许入组。 18.患有活动性或有病史记录的炎症性肠病（如克罗恩病、溃疡性结肠炎）、活动性憩室炎。 19.已知异体器官移植史和异体造血干细胞移植史。 20.已知间质性肺病或非感染性肺炎的病史。 21.已知对其他单克隆抗体产生严重超敏反应的病史。 22.已知对顺铂有任何禁忌症。 23.妊娠期或哺乳期女性。 24.研究者认为可能会导致接受研究药物治疗有风险，或将干扰研究药物的评价或受试者安全性或研究结果解析的任何状况（如患有其他严重疾病或精神类疾病等）

Exclusion criteria：

1. Subjects with other pathological histological types of cervical cancer, such as neuroendocrine carcinoma, sarcoma, etc. 2. Evidence of distant metastasis, including inguinal lymph node metastasis and lymph node metastasis above the level of the upper edge of the proximal L1 vertebra. 3. A total hysterectomy (resection of the uterine body + cervix) was performed. A history of surgery to preserve the cervix, such as subtotal hysterectomy or uterine angle resection, is allowed. 4. Brachytherapy cannot be used due to anatomical abnormalities and other reasons. 5. MRI imaging cannot be performed with an indwelling metal intrauterine device. 6. Suffering from other active malignant tumors within 2 years before randomization, except for locally curable tumors that appear to have been cured, such as squamous cell carcinoma of the skin, basal cell carcinoma of the skin, superficial bladder cancer, and breast carcinoma in situ. 7. There is clinically significant bilateral hydronephrosis, which cannot be relieved by nephrostomy or ureteral stent placement as determined by the investigator. 8. Subjects who have received any treatment targeting tumor immune mechanisms, such as immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.) or immune co-stimulatory factors (such as antibodies targeting ICOS, CD40, CD137, GITR, OX40 targets, etc.). 9. Subjects who need systemic treatment with glucocorticoids (> 10 mg/day prednisone or equivalent dose of glucocorticoids) or other immunosuppressive drugs within 2 weeks before randomization; except for the following: a) Inhaled, ophthalmic or topical glucocorticoid treatment with a dose of <= 10 mg/day prednisone or equivalent dose is allowed. b) Physiological glucocorticoid replacement therapy, with a dose of <= 10 mg/day prednisone or equivalent dose of glucocorticoids. c) Glucocorticoids as a preventive medication for hypersensitivity reactions (such as medication before CT examination). Received immunomodulatory drugs (such as thymosin, interferon, interleukin-2) within 2 weeks before randomization 10. Received immunomodulatory drugs (such as thymosin, interferon, interleukin-2) within 2 weeks before randomization. 11. Active infection requiring systemic treatment (including active pulmonary tuberculosis, active syphilis spirochete infection and fungal infection requiring systemic treatment), note: antiviral drugs used for hepatitis B virus are excluded. 12. Severe infection within 4 weeks before randomization, including but not limited to complications requiring hospitalization, sepsis or severe pneumonia. 13. Received major surgical treatment (determined by the investigator), open biopsy or significant trauma within 4 weeks before randomization; or required elective major surgical treatment during the study. Systematic pelvic/para-aortic lymphadenectomy for diagnostic purposes is allowed. 14. Used live vaccines within 4 weeks before randomization. 15. Patients with active or recurrent autoimmune diseases, except for the following: vitiligo, alopecia, psoriasis or eczema that do not require systemic treatment; hypothyroidism caused by autoimmune thyroiditis that only requires a stable dose of hormone replacement therapy; type I diabetes that only requires a stable dose of insulin replacement therapy. Any of the following cardiovascular and cerebrovascular diseases: a) Hypertension that cannot be controlled despite adequate antihypertensive drug treatment (defined as systolic blood pressure >150 mmHg, diastolic blood pressure >100 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy; b) Myocardial infarction, unstable angina, pulmonary embolism, aortic dissection, deep vein thrombosis, and any arterial thromboembolic events within 6 months before randomization; c) Heart failure with New York Heart Association (NYHA) functional class >= II; d) Severe arrhythmias requiring long-term drug intervention; asymptomatic patients with atrial fibrillation and stable ventricular rate are allowed to be enrolled; e) Cerebrovascular events (CVA) within 6 months before randomization; f) Left ventricular ejection fraction (LVEF) < 50%; g) History of myocarditis or cardiomyopathy. 16. Known primary or secondary immunodeficiency, including positive human immunodeficiency virus (HIV) antibody test. 17. Subjects with active hepatitis B, inactive or asymptomatic hepatitis B virus (HBV) carriers (HBsAg positive) with HBV DNA>1000 IU/mL, and subjects with active hepatitis C. Note: Inactive or asymptomatic carriers, treated and stable hepatitis B subjects with HBV DNA<=1000 IU/mL are allowed to enroll. Cured hepatitis C subjects, subjects with positive HCVAb and negative HCVRNA are allowed to enroll. 18. Active or documented inflammatory bowel disease (such as Crohn's disease, ulcerative colitis), active diverticulitis. 19. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 20. Known history of interstitial lung disease or non-infectious pneumonia. 21. Known history of severe hypersensitivity reactions to other monoclonal antibodies. 22. Any known contraindications to cisplatin. 23. Pregnant or lactating women. 24.Any condition that the researcher believes may lead to risk of receiving the study drug, or interfere with the evaluation of the study drug or the safety of the subjects or the interpretation of the study results (such as other serious diseases or mental illnesses, etc.)

研究实施时间：

Study execute time：

从 From 2024-05-23 00:00:00至 To 2027-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-09-10 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：	观察组	样本量：	40
Group：	observed group	Sample size：	40
干预措施：	卡度尼利单抗联合同步放化疗	干预措施代码：
Intervention：	Cadonilimab with chemoradiotherapy	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	天津市	市(区县)：
Country：	China	Province：	Tianjin	City：
单位(医院)：	天津市肿瘤医院空港医院	单位级别：	三级
Institution hospital：	Tianjin Cancer Hospital Airport Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	2年无进展生存率	指标类型：	主要指标
Outcome：	2-year progression-free survival rate	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	3年无进展生存率	指标类型：	次要指标
Outcome：	3-year progression-free survival rate	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	无进展生存期	指标类型：	次要指标
Outcome：	progression-free survival	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	客观缓解率	指标类型：	次要指标
Outcome：	Objective response rate	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	疾病控制率	指标类型：	次要指标
Outcome：	Disease control rate	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 Response	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	平均缓解时间	指标类型：	次要指标
Outcome：	Time to response	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	总生存期	指标类型：	次要指标
Outcome：	Overall survival	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	3年总生存率	指标类型：	次要指标
Outcome：	3-year overall survival rate	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	5年总生存率	指标类型：	次要指标
Outcome：	5-year overall survival rate	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：	癌旁组织	组织：
Sample Name：	Tissue adjacent to the tumor	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

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：

标本中文名：	肿瘤组织	组织：
Sample Name：	Tumor tissue	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：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	non	岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

无

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

none

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	否No
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）：	通过邮箱联系共享：zchen01@tmu.edu.cn,在试验结束六个月时间后可联系
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Please contact us via email for sharing: zchen01@tmu.edu.cn,
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：	病理记录表
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Case Record Form
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2025-11-10 08:12:30