NCT05690035撤回2 期
PD-1 Antibody (Tislelizumab) Combined With VEGFR 1/2/3 Inhibitor (Fruquintinib) for ARID1A-mutated Metastatic pMMR/MSS Colorectal Cancer: an Open-label, Multi-center, Phase II Clinical Trial
Sun Yat-sen University2 个研究点 分布在 1 个国家开始时间: 2025年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is an open-label phase II study, with the aim of investigating the efficacy and safety of Tislelizumab + Fruquintinib combination therapy in ARID1A-mutated pMMR/MSS metastatic colorectal cancer who have been treated with standard chemotherapy that includes fluoropyrimidine, oxaliplatin, and irinotecan. Patients with hypermutated CRC that carries POLE/POLD1 mutations cannot be included.
详细描述
In this open-label phase II study, patients with ARID1A-mutated pMMR/MSS metastatic colorectal cancer who have been treated with standard chemotherapy that includes fluoropyrimidine, oxaliplatin, and irinotecan, will be scheduled for Tislelizumab (200mg ivdrip Q3W day1) + Fruquintinib (5mg/day Q3W day1-14) until intolerable toxicity, disease progression or death. Primary endpoint of this study is ORR and secondary endpoints are OS, PFS, DCR 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old (including 18 and 80);
- •Histologically confirmed colorectal adenocarcinoma and biopsy pathology confirmed MSS/pMMR;
- •Gene testing confirmed ARID1A gene mutation (nonsynonymous);
- •No signs of intestinal obstruction; Or intestinal obstruction has been relieved after proximal colostomy;
- •Has received and failed ≥ 2 line of chemotherapy or progressed on or intolerable to oxaliplatin, irinotecan and fluorouracil chemotherapy after diagnosed with mCRC;
- •ECOG PS 0-2;
- •Able to swallow tablets;
- •Life expectancy of greater than 3 months;
- •Adequate bone marrow and organ function;
- •If female and of childbearing potential, must:
- •Have a negative pregnancy test ≤14 days prior to initiating study treatment
- •Agree to avoid pregnancy during and for 3 months after study treatment
- •If male with a partner of childbearing potential, must:
- •Agree to use adequate, medically approved, contraceptive precautions during and for 3 months after the last dose of study treatment.
- •Able and willing to provide written informed consent for the study.
排除标准
- •Any active autoimmune disease or history of autoimmune disease;
- •Those who are using immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve immunosuppressive purpose, and continue to use within 2 weeks before enrollment;
- •Severe allergic reaction to other monoclonal antibodies;
- •Subjects with clinical symptoms of untreated active brain metastasis or meningeal metastasis;
- •Have received other PD-1 antibody therapy or other immunotherapy targeting PD-1/PD-L1 in the past;
- •Patients with high TMB (≥ 30Muts/Mb) and germline or somatic POLE/POLD1 gene mutations in the exonuclease domain;
- •There are clinical symptoms or diseases of heart that are not well controlled, such as: (a) heart failure of NYHA level 2 or above (b) unstable angina pectoris (c) myocardial infarction occurred within 1 year (d) clinically significant supraventricular or ventricular arrhythmia needs treatment or intervention;
- •Known hereditary or acquired bleeding and thrombophilia or being treated with thrombolysis or anticoagulation;
- •Urinary protein ≥ ++, or the 24-hour urine protein quantification greater than 1.0g;
- •Clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment;
- •Subjects with active infection;
- •Congenital or acquired immune deficiency (such as HIV infected persons), or active hepatitis (hepatitis B: HBsAg positive and HBV DNA ≥ 10^4 copies/ml; hepatitis C: HCV antibody positive);
- •Other advanced malignant tumors within 5 years (except cured skin basal cell carcinoma, cervical carcinoma in situ, ovarian cancer, thyroid cancer and breast cancer);
- •Live vaccine may be inoculated less than 4 weeks before the study medication or during the study period;
- •Known or suspected to be allergic to the study drug or to any drug given in this trial;
- •Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions that makes the subject not eligible according to the judgment of the investigator.
研究组 & 干预措施
patients with mCRC
Experimental
Tislelizumab 200mg ivdrip every 3 weeks; Fruquintinib 5mg qd day 1-14, every 3 weeks
干预措施: Tislelizumab & Fruquintinib (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: up to 3 years
The proportion of patients with a confirmed complete response or partial response
次要结局
- Disease control rate(up to 3 years)
- Incidence of Treatment-Emergent Adverse Events(until 60 days after last patient last study drug treatment)
- Progression-Free Survival (PFS)(up to 3 years)
- Overall Survival (OS)(up to 3 years)
研究者
Pei-Rong Ding
Professor
Sun Yat-sen University
研究点 (2)
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