A Prospective, Single-arm, Multicenter Phase II Clinical Study of Iparomlimab and Tuvonralimab Combined With Bevacizumab and Alternating Triweekly CAPOX/mCAPIRI Regimen as First-line Treatment for Unresectable Advanced Colorectal Cancer
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Jiangsu Cancer Institute & Hospital
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Investigator-assessed Objective Response Rate（ORR）
概览
简要总结
This study is a prospective, single-arm, multicenter exploratory clinical study aimed at evaluating the efficacy and safety of iparomlimab and tuvonralimab combined with bevacizumab and alternating triweekly CAPOX/mCAPIRI regimen as first-line treatment for unresectable advanced colorectal cancer. The study plans to enroll 70 patients with unresectable advanced metastatic colorectal cancer. After evaluation and confirmation of meeting enrollment criteria, patients will receive treatment with iparomlimab and tuvonralimab combined with bevacizumab and alternating triweekly CAPOX/mCAPIRI regimen. The primary endpoint of the study is ORR, and secondary endpoints include PFS, DoR, OS, and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •1\. Age 18-75 years;
- •2\. Patients with histologically or cytologically confirmed unresectable, advanced colorectal cancer;
- •3\. No prior systemic treatment;
- •4\. ECOG PS score ≤2;
- •5\. Expected survival ≥3 months;
- •6\. MSS/MSI-L status;
- •7\. At least one evaluable lesion based on RECIST 1.1 criteria;
- •8\. No prior systemic chemotherapy or other systemic therapy, or only received adjuvant chemotherapy with disease progression or recurrence within 6 months after completion of treatment;
- •9\. Adequate organ function reserve, with specific hepatic, renal, and hematologic parameters as follows:
- •White blood cell count ≥3.5×10⁹/L
排除标准
- •1\. Prior hypersensitivity to any of the study drugs;
- •2\. Active or known or suspected autoimmune disease requiring systemic treatment, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilator intervention;
- •3\. Presence of non-measurable lesions (e.g., pleural effusion/ascites, carcinomatous lymphangitis, diffuse liver involvement, bone metastases);
- •4\. Pregnant or lactating women;
- •5\. Uncontrolled symptomatic brain metastases or psychiatric disorders preventing accurate expression of subjective symptoms;
- •6\. Vital organ function failure;
- •7\. Conditions affecting drug absorption/distribution/metabolism/excretion (e.g., seizures, central nervous system diseases, cognitive impairment due to psychiatric disorders, chronic diarrhea, cachexia, etc.);
- •8\. Patients with complete or incomplete intestinal obstruction;
- •9\. History of severe cardiac disease (including congestive heart failure, uncontrolled high-risk arrhythmia, angina requiring medication, definite valvular heart disease history, severe myocardial infarction, refractory hypertension);
- •10\. Active infection requiring systemic treatment;
研究组 & 干预措施
QL1706+ bevacizumab+chemotherapy
The study consists of a 6-cycle induction treatment phase and a maintenance treatment phase. During the induction phase, patients receive iparomlimab and tuvonralimab combined with bevacizumab and chemotherapy. During the maintenance phase, patients receive iparomlimab and tuvonralimab combined with bevacizumab and capecitabine until disease progression or intolerable toxicity.
干预措施: Iparomlimab and tuvonralimab (Drug)
结局指标
主要结局
Investigator-assessed Objective Response Rate（ORR）
时间窗: From enrollment to the end of treatment at 18 months
CR+PR
次要结局
- Investigator-assessed Progression-Free Survival（PFS）(From enrollment to the end of treatment at 18 months)
- Investigator-assessed Duration of Response（DoR）(From enrollment to the end of treatment at 18 months)
- Overall Survival（OS）(From enrollment to the end of treatment at 36 months)
- AE(From enrollment to the end of treatment at 12 weeks)
研究者
Liangjun Zhu M.M.
Chief Physician, Department of Medical Oncology
Jiangsu Cancer Institute & Hospital