ChiCTR2400092345 版本V1.0 版本创建时间2024/11/14 14:57:13 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2400092345 

最近更新日期：

Date of Last Refreshed on：

2024-11-14 14:57:07 

注册时间：

Date of Registration：

2024-11-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评价盐酸伊立替康脂质体注射液（Ⅱ）联合卡培他滨、贝伐珠单抗用于既往一线标准治疗失败的转移性结直肠癌（mCRC）： 一项前瞻性、多中心、探索性临床研究

Public title：

Evaluation of irinotecan hydrochloride liposome injection (II) in combination with capecitabine and bevacizumab in metastatic colorectal cancer (mCRC) patients who have failed previous first-line standard therapy: a prospective, multicenter, exploratory clinical study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价盐酸伊立替康脂质体注射液（Ⅱ）联合卡培他滨、贝伐珠单抗用于既往一线标准治疗失败的转移性结直肠癌（mCRC）： 一项前瞻性、多中心、探索性临床研究

Scientific title：

Evaluation of irinotecan hydrochloride liposome injection (II) in combination with capecitabine and bevacizumab in metastatic colorectal cancer (mCRC) patients who have failed previous first-line standard therapy: a prospective, multicenter, exploratory clinical study

研究课题代号(代码)：

Study subject ID：

 JS-GI 2401

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：

李晟 

研究负责人：

李晟 

Applicant：

Li Shen 

Study leader：

Li Shen 

申请注册联系人电话：

Applicant telephone：

+86 137 7076 8636

研究负责人电话：

Study leader's telephone：

+86 137 7076 8636

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：

lihsh198@163.com

研究负责人电子邮件：

Study leader's E-mail：

lihsh198@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：

南京市百子亭42号

研究负责人通讯地址：

南京市百子亭42号

Applicant address：

No. 42, Baiziting, Nanjing

Study leader's address：

No. 42, Baiziting, Nanjing

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：

江苏省肿瘤医院

Applicant's institution：

Jiangsu Cancer Hospital

研究负责人所在单位：

江苏省肿瘤医院

Affiliation of the Leader：

Jiangsu Cancer Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2024-015

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：

江苏省肿瘤医院伦理委员会

Name of the ethic committee：

Ethics Committee of Jiangsu Cancer Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-09-12 00:00:00

伦理委员会联系人：

刘小林

Contact Name of the ethic committee：

Liu Xiaolin

伦理委员会联系地址：

江苏省南京市百子亭42号

Contact Address of the ethic committee：

No. 42, Baiziting, Nanjing City, Jiangsu Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 25 8328 4707

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：

江苏省肿瘤医院

Primary sponsor：

Jiangsu Cancer Hospital

研究实施负责（组长）单位地址：

南京市百子亭42号

Primary sponsor's address：

No. 42, Baiziting, Nanjing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏

市(区县)：

南京

Country：

China

Province：

Jiangsu

City：

Najing

单位(医院)：

江苏省肿瘤医院

具体地址：

南京市百子亭42号

Institution
hospital：

Jiangsu Cancer Hospital

Address：

No. 42, Baiziting, Nanjing

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

Target disease：

metastatic colorectal cancer

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期+II期 

Study phase：

1-2

研究设计：

单臂 

Study design：

Single arm 

研究目的：

一、主要研究目的（1）第一阶段：安全性导入，评价盐酸伊立替康脂质体注射液（Ⅱ）联合卡培他滨、贝伐珠单抗二线治疗转移性结直肠癌的安全性和耐受性；确定后续临床试验中盐酸伊立替康脂质体注射液（Ⅱ）的 RP2D。（2）第二阶段：疗效拓展，通过评估客观缓解率（ORR），评价盐酸伊立替康脂质体注射液（Ⅱ）联合卡培他滨、贝伐珠单抗二线治疗转移性结直肠癌的有效性。 二、 次要研究目的，第二阶段：疗效拓展，通过评估总生存期（OS）、无进展生存期（PFS）和疾病控制率（DCR），评价盐酸伊立替康脂质体注射液（Ⅱ）联合卡培他滨、贝伐珠单抗二线治疗转移性结直肠癌的有效性；评价盐酸伊立替康脂质体注射液（Ⅱ）联合卡培他滨、贝伐珠单抗二线治疗转移性结直肠癌的安全性。  

Objectives of Study：

(1) Phase I: Safety introduction to evaluate the safety and tolerability of irinotecan hydrochloride liposome injection (ii) combined with capecitabine and bevacizumab in the second-line treatment of metastatic colorectal cancer; To determine the RP2D of irinotecan hydrochloride liposome injection (II) in a follow-up clinical trial. (2) The second stage: efficacy expansion. The efficacy of irinotecan hydrochloride liposome injection (II) combined with capecitabine and bevacizumab in the second-line treatment of metastatic colorectal cancer was evaluated by evaluating the objective response rate (ORR). Second phase: Efficacy expansion. To evaluate the efficacy of irinotecan hydrochloride liposome injection (ii) combined with capecitabine and bevacizumab in the second-line treatment of metastatic colorectal cancer by evaluating overall survival (OS), progression-free survival (PFS) and disease control rate (DCR). To evaluate the safety of irinotecan hydrochloride liposome injection (Ⅱ) combined with capecitabine and bevacizumab in second-line treatment of metastatic colorectal 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. 年龄≥18 岁且≤75 岁，性别不限； 2. 经病理组织学和/或细胞学诊断结肠或直肠癌，临床记录显示为不可手术切除的晚期转移性结肠癌或直肠癌（即，根据 UICC/AJCC TNM 分期系统[2017 年第 8 版]分为 IV 期）； 3. 根据 RECIST v1.1 标准，至少具有 1 个可测量靶病灶（即，非淋巴结病灶 CT 扫描长径≥10 mm，淋巴结病灶 CT 扫描短径≥15 mm）； 4. 既往接受过针对转移性疾病的奥沙利铂±VEGF/EGFR 一线标准治疗且治疗失败或不耐受*； 注：*治疗失败或不耐受的定义：（1）治疗过程中疾病进展或末次治疗后的 6 个月内疾病进展，均有明确的影像学或临床进展证据；（2）因无法耐受治疗不良事件而退出一线治疗的患者，按 NCI-CTCAE v5.0 标准，不耐受的定义为：a. 血液学毒性：III 级的中性粒细胞减少伴随＞38.5℃的发热、III 级血小板减少伴出血症状、其他 IV 级及以上血液毒性反应；b.非血液学毒性：III 级及以上非血液毒性反应；c. 达到上述毒性反应，经研究者判断不适合继续进行原治疗方案治疗。 5. 美国东部肿瘤协作组（ECOG） 体力状态评分 0-1； 6. 预期生存时间≥3 个月； 7. 无主要器官的功能障碍，即开始研究治疗前 14 天内受试者的器官功能水平及相关实验室指标必须符合下列要求： (1) 血常规（开始研究治疗前 14 天内未进行过输血、输血小板、生长因子等支持治疗）：白细胞（WBC）≥3.0×109/L；中性粒细胞绝对计数（ANC）≥1.5×109/L；血小板计数（PLT）≥100×109/L；血红蛋白（Hb）≥90 g/L (2) 血生化：血清白蛋白 （ ALB ）≥ 30 g/L ；谷丙 转氨酶（ALT ） / 谷草 转氨酶（AST）≤2.5 倍正常值上限（ULN），如有肝转移则 ALT/AST≤5×ULN；总胆红素（TBIL）≤1.5×ULN；血清肌酐（Cr） ≤1.5×ULN，或根据 Cockcroft-Gault 公式计算的内生肌酐清除率≥60 mL/min (3) 尿常规：尿常规提示尿蛋白<++；若基线时尿蛋白≥++ ，需证实 24 小时尿蛋白定量≤1.0g。 (4) 凝血功能（开始研究治疗前 14 天内）：凝血酶原时间（PT）或活化部分凝血活酶时间（aPTT）≤1.5×ULN、国际标准化比值（INR）≤1.5 ×ULN（未接受过抗凝治疗）；若受试 者应用使用稳定剂量的抗凝剂或维生素 K 拮抗剂（如华法林、肝素或其类似物治疗），在凝血酶原时间国际标准化比值（INR）≤ 1.5 的前提下，允许以预防目的使用小剂量华法林（1mg 口服，每日一次）或小剂量阿司匹林（每日用量不超过 100 mg）； (5) 心脏功能：12-导联心电图正常或经研究者判断无临床意义的 12-导联心电图异常（即，男性 QTcF＜450 ms，女性 QTcF＜470 ms）；左室射血分数（LVEF）≥正常值低限（即，LVEF≥50%）； 8. 既往接受的其他抗肿瘤治疗需结束治疗 4 周及以上，且一般的身体状况或相关的不良反应已恢复（毒性反应≤1 级）或达到稳定状态； 9. 开始研究治疗前 7 天内育龄妇女血清妊娠试验必须为阴性，且必须为非哺乳期；育龄期女性受试者或伴侣为育龄期女性的男性受试者必须同意在试验期间和研究治疗期结束后6 个月内采取医学许可的避孕措施（例如，宫内节育器、男性手术绝育、避孕药或避孕套）； 10. 自愿参加并签署知情同意书，并能依从研究访视计划和其它方案要求。

Inclusion criteria

1. Age ≥18 years old and ≤75 years old, regardless of gender; 2. Diagnosis of colon or rectal cancer by histopathology and/or cytology with clinical records showing advanced metastatic colon or rectal cancer that is inoperable (i.e., stage IV according to the UICC/AJCC TNM staging system [8th edition 2017]); 3. According to the RECIST v1.1 standard, there should be at least one measurable target lesion (that is, the length of CT scan for non-lymph node lesions ≥10 mm, and the short diameter of CT scan for lymph node lesions ≥15 mm); 4. Previous first-line standard oxaliplatin ±VEGF/EGFR therapy for metastatic disease and treatment failure or intolerance *; * Definitions of treatment failure or intolerance: (1) disease progression during treatment or within 6 months after the last treatment, with clear imaging or clinical evidence of progression; (2) For patients who withdrew from first-line therapy due to an adverse event that they could not tolerate, intolerance was defined according to NCI-CTCAE v5.0 standards as: a. Hematological toxicity: Grade III neutropenia with fever > 38.5℃, grade III thrombocytopenia with bleeding symptoms, other grade IV and above hematological toxicity; b. Non-hematological toxicity: Grade III and above non-hematological toxicity; c. If the above toxic reactions are achieved, the researchers judge that it is not suitable to continue the original treatment regimen. 5. Physical status score 0-1 of the Eastern Oncology Consortium (ECOG); 6. Expected survival time ≥3 months; 7. No major organ dysfunction, that is, the organ function level and related laboratory indicators of the subjects within 14 days before the start of the study and treatment must meet the following requirements: (1) blood routine (no blood transfusion, platelet transfusion, growth factor and other supportive treatment within 14 days before the start of the study and treatment) : white blood cell (WBC) ≥3.0×109/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count (PLT) ≥100×109/L; Hemoglobin (Hb) ≥90 g/L (2) Blood biochemistry: serum albumin (ALB) ≥ 30 g/L; Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN), if there is liver metastasis ALT/AST≤5×ULN; Total bilirubin (TBIL) ≤1.5×ULN; Serum creatinine (Cr) ≤1.5×ULN, or endogenous creatinine clearance ≥60 mL/min as calculated by Cockcroft-Gault formula (3) Urine routine: urine routine indicates urine protein <++; If urinary protein ≥++ at baseline, it is necessary to confirm that the 24-hour urinary protein quantity is ≤1.0g. (4) Coagulation function (within 14 days before the start of study treatment) : prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤1.5×ULN, International normalized ratio (INR) ≤1.5×ULN (did not receive anticoagulant therapy); Under test Patients should be treated with stable dose anticoagulants or vitamin K antagonists (such as warfarin, heparin, or their equivalents), and low doses of warfarin (1mg orally, 1mg orally, 1mg orally, 1mg orally, 1mg orally, and 1mg orally, are permitted for prophylactic purposes under the condition that the International Normalized ratio of prothrombin time (INR) is ≤ 1.5. Once daily) or low-dose aspirin (up to 100 mg daily); (5) Cardiac function: normal 12-lead electrocardiogram or abnormal 12-lead electrocardiogram judged by the investigator to be clinically insignificant (i.e., QTcF < 450 ms in men and QTcF < 470 ms in women); Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (i.e., LVEF≥50%); 8. Other anti-tumor treatments received in the past must be completed for 4 weeks or more, and the general physical condition or related adverse reactions have recovered (toxicity ≤ grade 1) or reached a stable state; 9. The serum pregnancy test for women of childbearing age must be negative within 7 days before the start of the study treatment, and must be non-lactating; A female subject of childbearing age or a male subject whose partner is a female of childbearing age must consent to use a medically licensed contraceptive method (e.g., IUD, male surgical sterilization, contraceptive pill or condom) during the trial period and within 6 months after the end of the study treatment period; 10. Voluntarily participate and sign informed consent, and be able to comply with the research visit plan and other program requirements.

排除标准：

1. 在筛选前 5 年内曾患有结直肠癌以外的恶性肿瘤（已治愈的皮肤基底细胞或鳞状上皮细胞癌、宫颈原位癌、研究者评估具有低风险转移和死亡风险的恶性肿瘤除外）； 2. 已知经肿瘤组织经免疫组化方法证实为错配修复缺陷（dMMR）状态，或二代测序（NGS）/聚合酶链式反应（PCR）方法确认为微卫星高不稳定性（MSI-H）状态，且经研究者评估适合接受免疫检查点抑制剂（PD-1/PD-L1 抑制剂）治疗。 3. 二代测序（NGS）/聚合酶链式反应（PCR）方法确认为 BRAF V600E 突变，对化疗预后不良的患者（注：入组前能够提供相关报告；无法提供报告的受试者，建议进行相应检测[非强制]）； 4. 已知有中枢神经系统转移者，对于临床疑似中枢神经系统转移的患者，开始研究治疗前 28 天内必须进行增强电子计算机断层扫描（CT）或增强核磁共振（MRI）检查，排除中枢神经系统转移； 5. 既往接受过伊立替康/伊立替康脂质体为基础的化疗； 6. 开始研究治疗前 14 天内使用 CYP3A4、CYP2C8 和 UGT1A1 强抑制剂/诱导剂； 7. 开始研究治疗前 4 周内参加过其他药物临床试验； 8. 临床记录显示有严重的胃肠功能紊乱（包括出血、梗阻；NCI-CTCAE v5.0＞2 级的炎症；NCI-CTCAE v5.0＞1 级的腹泻），或经研究者判断可能会影响药物的摄入、转运或吸收的其他情况（包括无法吞咽；小肠切除术后或全胃切除等）； 9. 需要临床干预的胸腔积液或腹水（NCI-CTCAE v5.0≥2 级）； 10. 存在妨碍试验药物治疗的严重合并症、活动性感染或未控制的糖尿病： (1) 研究者认为会影响受试者接受研究方案治疗能力的未受控制的严重医学疾病，例如 合并严重的内科疾病，包括严重心脏病、脑血管病、未控制的糖尿病、未控制的高血压、不受控制的感染、活动性消化性溃疡等； (2) 筛选前一年内发生过动/静脉血栓事件，如脑血管意外（包括暂时性缺血性发作）、深静脉血栓（因前期化疗行静脉置管引发静脉血栓经研究者判断已痊愈者除外）及肺栓塞等； (3) 影像学显示肿瘤已侵犯重要血管周围或经研究者判断患者肿瘤在治疗期间有极高可能侵袭重要血管而引起致命大出血的情况； (4) 既往有间质性肺病，或有（非感染性）肺炎且需口服或静脉类固醇激素； (5) 有未能良好控制的心脏临床症状或疾病，如：纽约心脏病协会（NYHA） 2 级以上心力衰竭；不稳定型心绞痛；6 个月内发生过心肌梗死；有临床意义、需要治疗或干预的室上性或室性心律失常； (6) 丙型肝炎病毒（HCV）抗体阳性或人免疫缺陷病毒（HIV）抗体阳性； 11. 筛选前 4 周内发生过严重感染（NCI-CTCAE v5.0＞2 级），如需要住院治疗的严重肺炎、菌血症、感染并发症等；开始研究治疗前 2 周内存在感染的症状和体征需要静脉使用抗生素治疗（预防性使用抗生素的情况除外）。 12. 已知对任意试验药物（盐酸伊立替康脂质体注射液（Ⅱ）、卡培他滨、贝伐珠单抗）或其辅料过敏或不能耐受，或存在任一试验药物禁忌症； 13. 研究者认为应排除在本研究之外，例如经研究者判断，受试者有其他可能导致本研究被迫中途终止的因素，如存在其他的严重疾病（含精神疾病）需要合并治疗，有严重的实验室检查异常，伴有家庭或社会等因素、会影响到受试者的安全或资料及样品的收集的。

Exclusion criteria：

1.Have had malignancies other than colorectal cancer in the 5 years prior to screening (except cured basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and malignancies assessed by investigators as having a low risk of metastasis and death); 2. The tumor tissue is known to be in mismatch repair defect (dMMR) state confirmed by immunohistochemistry, or microsatellite high instability (MSI-H) state confirmed by second-generation sequencing (NGS)/polymerase chain reaction (PCR) method, It was evaluated by the researchers to be suitable for treatment with immune checkpoint inhibitors (PD-1/PD-L1 inhibitors) (Note: relevant reports could be submitted before enrollment; For subjects unable to provide a report, corresponding testing is recommended [optional]); 3. Second-generation sequencing (NGS)/polymerase chain reaction (PCR) method confirmed BRAF V600E mutation for patients with poor prognosis after chemotherapy (Note: relevant reports can be provided before entestation; For subjects unable to provide a report, corresponding testing is recommended [optional]); 4. For patients with known CNS metastases and clinically suspected CNS metastases, enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI) must be performed within 28 days before the start of the study to rule out CNS metastases; 5. Previously received irinotecan/irinotecan liposome based chemotherapy; 6. Use of CYP3A4, CYP2C8, and UGT1A1 suppressors/inducers within 14 days prior to initiation of study therapy; 7. Participated in other drug clinical trials within 4 weeks before starting the study treatment; 8. Clinical records show severe gastrointestinal dysfunction (including bleeding, obstruction; NCI-CTCAE v5.0 > Grade 2 inflammation; Diarrhea (NCI-CTCAE v5.0 > 1), or other conditions (including inability to swallow) that the investigator determines may affect the ingestion, transport, or absorption of the drug; Small bowel resection or total gastrectomy, etc.); 9. Pleural effusion or ascites requiring clinical intervention (NCI-CTCAE v5.0≥2); 10. The presence of serious comorbidities, active infections, or uncontrolled diabetes that impede treatment with the investigational drug: (1) A serious, uncontrolled medical condition that the investigator believes will affect the subject's ability to be treated with the study protocol, for example, complicated with serious internal disease, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.; (2) Occurrence of arteriovenous thrombosis events within one year prior to screening, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis (except venous thrombosis caused by intravenous catheterization in previous chemotherapy and cured by investigators) and pulmonary embolism; (3) Imaging shows that the tumor has invaded the vicinity of important blood vessels or the investigator determines that the patient's tumor is highly likely to invade important blood vessels during treatment and cause fatal massive bleeding; (4) Prior interstitial lung disease, or (non-infectious) pneumonia requiring oral or intravenous steroid hormones; (5) have clinical symptoms or diseases of the heart that are not well controlled, such as: New York Heart Association (NYHA) level 2 or higher heart failure; Unstable angina pectoris; Myocardial infarction within 6 months; Supraventricular or ventricular arrhythmias that are clinically significant and require treatment or intervention; (6) Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive; 11. Serious infections (NCI-CTCAE v5.0 > Grade 2) occurred within 4 weeks prior to screening, such as severe pneumonia requiring hospitalization, bacteremia, and infection complications; The presence of signs and symptoms of infection within 2 weeks prior to the start of study treatment required intravenous antibiotic treatment (except in the case of prophylactic antibiotic use). 12. Known allergy or intolerance to any drug (irinotecan hydrochloride liposome injection (II), capecitabine, bevacizumab) or its excipients, or contraindications to any drug; 13. The investigator considers that the subjects should be excluded from the study, for example, the subjects have other factors that may lead to the forced termination of the study, such as the presence of other serious diseases (including mental illness) requiring combined treatment, serious abnormalities in laboratory tests, family or social factors, which will affect the safety of the subjects or the collection of data and samples.

研究实施时间：

Study execute time：

从 From 2024-11-30 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-12-15 00:00:00 至 To 2025-12-31 00:00:00  

干预措施：

Interventions：

组别：

安全导入阶段（safety run in）：伊立替康脂质体+卡培他滨 +贝伐珠单抗

样本量：

12

Group：

safety run in:Irinotecan liposome + capecitabine + bevacizumab

Sample size：

干预措施：

盐酸伊立替康脂质体注射液（II）80mg/m2（若出发剂量下调规则，则调整为60mg/m2）+卡培他滨 800 mg/m+贝伐珠单抗7.5 mg/kg

干预措施代码：

Intervention：

safety run in. Irinotecan hydrochloride liposome injection (II) 80 mg/m2 (or 60mg/m2,if trigger dose down regulation)+ capecitabine 800 mg/m2+ bevacizumab 7.5 mg/kg

Intervention code：

组别：

疗效拓展阶段（ Efficacy expansion stage）：伊立替康脂质体+卡培他滨 +贝伐珠单抗

样本量：

54

Group：

Efficacy expansion stage: Irinotecan liposome + capecitabine + bevacizumab

Sample size：

干预措施：

疗效拓展：盐酸伊立替康脂质体注射液（II）RP2D+卡培他滨 800 mg/m2+贝伐珠单抗7.5 mg/kg

干预措施代码：

Intervention：

Efficacy expansion stage: Irinotecan hydrochloride liposome injection (II) RP2D+ capecitabine 800 mg/m+ bevacizumab 7.5 mg/kg

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

 南京 

Country：

China 

Province：

Jiangsu  

City：

Nanjing  

单位(医院)：

江苏省肿瘤医院 

单位级别：

三甲 

Institution
hospital：

Jiangsu Cancer Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

 南京 

Country：

China 

Province：

Jiangsu  

City：

Nanjing  

单位(医院)：

南京市中医院 

单位级别：

三甲 

Institution
hospital：

Nanjing Traditional Chinese Medicine Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

 镇江 

Country：

China 

Province：

Jiangsu  

City：

zhenjiang 

单位(医院)：

镇江市第一人民医院 

单位级别：

三甲 

Institution
hospital：

The First People's Hospital of Zhenjiang City

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

客观缓解率

指标类型：

主要指标

Outcome：

objective remission 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：

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：

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：

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：

安全性

指标类型：

次要指标

Outcome：

security

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

 其它  

说明

Fate of sample：

0thers  

Note：

标本中文名：

尿液

组织：

Sample Name：

urine

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 75 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）：

本研究为单臂研究，无随机

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

This study was a one-arm study and was not randomized

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：

无

Blinding：

None

是否共享原始数据：

IPD sharing

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）：

不共享

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Not shared

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

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：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-11-14 14:57:07