NCT06455254招募中2 期
A Single-arm, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of Candonilimab（AK104） Combined With Regorafenib For the Third-line Treatment of MSS Colorectal Liver Metastasis
Jin-hong Chen3 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年7月11日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 3
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of Candonilimab (AK104) combined with Regorafenib for the treatment of MSS colorectal liver metastasis. Candonilimab (AK104) is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4.
详细描述
This is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of Candonilimab (AK104) combined with Regorafenib for the treatment of MSS colorectal liver metastasis. The purpose of the study is to observe and evaluate the efficacy and safety of Cadonilimab in combination with Regorafenib in patients with CRLM who had failed the previous second-line standard regimen, and to explore biomarkers related to efficacy.
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
- •Age > 18 years old and < 75 years old;
- •ECOG Performance status score 0 or 1;
- •Histologically or cytologically confirmed adenocarcinoma of colon or rectum, with liver metastases, with or without extrahepatic metastases;
- •At least one measurable lesion as defined by RECIST version 1.1;
- •Progressed or be intolerant to prior systemic therapy including fluoropyrimidines, irinotecan, oxaliplatin, bevacizumab and/or cetuximab/panitumumab (if RAS/RAF-wild-type);
- •Known RAS and BRAF status;
- •Only patients with mismatch repair-proficient (pMMR)/microsatellite stable (MSS) status;
- •Adequate bone-marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment:
- •Liver and renal function: Total bilirubin ≤ 1.5× ULNl; aspartate transaminase (AST), alanine transaminase (ALT) ≤ 5× ULN; Serum creatinine ≤ 1.5× ULN; Bone-marrow function: Neutrophil count ≥ 1.5×10^9/L, Hemoglobin (Hb) ≥ 9.0 g/dL, Platelet count ≥ 100×10^9/L; International normalised ratio (INR) and partial thromboplastin time (PTT) ≤1.5 × ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of an underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care；
- •Patients of childbearing potential must be willing to use highly effective contraception for the duration of the study and for ≥120 days after the last dose of cadonilimab; female patients with a negative urine or serum pregnancy test result within ≤3 days prior to the first dose of the drug;
- •Able to understand and voluntarily sign written informed consent;
- •No history of allergy to regorafenib, cadonilimab and its components.
排除标准
- •Women who are pregnant or breastfeeding;
- •Patients who have previously been treated with third-line regimens such as regorafenib, fruquintinib, trifluridine tipiracil, or other immune checkpoint inhibitors, including anti-PD-1, anti-PD-L1, anti-CTLA-4, or any cellular immunotherapy;
- •Active autoimmune disease requiring systemic therapy within the past 2 years (e.g., treatment with disease-modifying drugs, corticosteroids, immunosuppressants), replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid therapy for adrenal or pituitary insufficiency) is not considered a systemic treatment;
- •Active or prior history of definite inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea);
- •Patients who have received intervention, ablation or radiotherapy within the previous 3 months for the target lesion;
- •Patients with an expected survival time of less than 3 months;
- •Study participants with other malignant tumors within 3 years prior to enrollment, excluding cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.);
- •Patients with severe psychological or psychiatric abnormalities;
- •No history of severe arrhythmia, heart failure, severe ventilatory dysfunction and severe lung infection, no acute and chronic renal failure;
- •Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study;
- •Any other clinically significant disease or condition that, in the opinion of the investigator, may affect adherence to the protocol, or the signing of the Informed Consent Form (ICF) by the subject, or make participation in this clinical trial inappropriate.
研究组 & 干预措施
Treatment arm
Experimental
Candonilimab (AK104) + Regorafenib
干预措施: Candonilimab (AK104) (Drug)
Treatment arm
Experimental
Candonilimab (AK104) + Regorafenib
干预措施: Regorafenib (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 6 months
ORR, determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
次要结局
- Disease Control Rate (DCR)(6 months)
- Duration of response (DoR)(6 months)
- Progression-free Survival (PFS)(6 months)
- Overall survival (OS)(2 years)
- Adverse event incidence rate (AE rate)(6 months)
研究者
Jin-hong Chen
Director, Clinical Professor
Fudan University
研究点 (3)
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