A Randomized, Multicenter, Phase Ⅱ/Ⅲ Study of RC148 Combined With Chemotherapy Versus Bevacizumab Combined With Chemotherapy as First-line Treatment for Unresectable or Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 19
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a Phase Ⅱ/Ⅲ study. The purpose of this study is to evaluate the efficacy and safety of RC148 combined with chemotherapy for the first-line treatment of unresectable metastatic colorectal cancer (CRC)
详细描述
Primary objective in Phase II: To preliminarily evaluate the efficacy of RC148 combined with chemotherapy as first - line treatment for unresectable or metastatic CRC.
Primary objective in Phase III: To evaluate the efficacy of RC148 combined with chemotherapy compared with bevacizumab combined with chemotherapy as first - line treatment for unresectable or metastatic CRC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The Phase II of this study is designed to be a randomized and open - label trial. The Phase III is a randomized and double - blind study, in which neither the researchers nor the subjects know the type of investigational drug given in addition to chemotherapy.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily agree to participate in the study, sign the informed consent form, and be able to comply with the study protocol.
- •Aged 18-75 years old (including 18 years old and 75 years old).
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •Expected survival period ≥ 12 weeks.
- •At least one measurable lesion according to RECIST v1.1 criteria.
- •Histologically or cytologically confirmed colorectal adenocarcinoma, judged by the investigator as unsuitable for curative treatment, and no prior systemic anti-tumor treatment in the recurrent or metastatic stage.
- •Subjects must be able to provide tumor tissue samples for biomarker detection.
- •Adequate bone marrow, liver, kidney, and coagulation function.
- •Female subjects of childbearing potential must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment, and must have a negative blood pregnancy test within 7 days before study enrollment; male subjects must agree to use at least one medically approved contraceptive method during the study treatment and for 6 months after the end of the study treatment.
排除标准
- •Known to have microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR).
- •Imaging shows obvious tumor necrosis or cavitation, and the investigator judges that participation in the study may increase the risk of bleeding.
- •Subjects with brain metastases.
- •Toxicities from prior anti-tumor therapy have not recovered to ≤ grade 1 according to NCI-CTCAE v6.
- •Known hypersensitivity or delayed-type allergy to any component of the study drug or similar drugs.
- •Subjects with refractory nausea and vomiting, chronic gastrointestinal diseases, or other diseases that may interfere the adequate absorption, distribution, metabolism, or excretion of oral drugs.
- •Subjects with acute, chronic, or symptomatic infections.
- •Subjects with diagnosed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severe impairment of lung function, or other lung diseases.
- •Subjects with active inflammatory bowel disease, a history of gastrointestinal perforation and/or fistula, or clinical symptoms of gastrointestinal obstruction.
- •Subjects with severe arterial/venous thromboembolic events within 6 months before randomization.
- •Active gastrointestinal bleeding, hemoptysis, peptic ulcer, or hemorrhagic events requiring intervention within 28 days before randomization; or presence of severe esophagogastric varices or epistaxis.
- •Presence of symptomatic or intervention-requiring third-space effusions.
- •Subjects with active or previously diagnosed autoimmune diseases that may recur.
- •History of other invasive malignant tumors within 5 years before randomization, or presence of any residual evidence of previously diagnosed malignant tumors.
- •Subjects who are pregnant, lactating, or planning to become pregnant.
研究组 & 干预措施
Experimental Group 1
Drug: RC148 （Dose1） in combination with CAPEOX
干预措施: RC148 (Dose 1) plus Capecitabine and Oxaliplatin (Drug)
Experimental Group 2
Drug: RC148 RC148 (Dose 2) in combination with CAPEOX
干预措施: RC148 (Dose 2) plus Capecitabine and Oxaliplatin (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 24 months
Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1
次要结局
- AEs/SAE(36 months)
- Duration of Response (DoR)(24 months)
- Disease Control Rate (DCR)(24 months)
- Time to Response (TTR)(24 months)
- Overall Survival (OS)(36 months)