计划状态
招聘阶段
第 1 阶段 第二阶段允许先接受免疫治疗
是CRC 指导的试验
是药物
Cadonilimab标签
MSI-H/ MMRd评论
Trial in China that admits only patients with MSI-H/MMRd cancer (not MSS) for whom previous treatment with an anti-PD-1 or PD-L1 monoclonal antibody for advanced or metastatic colorectal cancer has failed.
Then, prior treatment with anti-PD-1 /PD-L1 is required; prior treatment with an anti CTLA-4 is not allowed.
Patients will receive Cadonilimab alone.
Cadonilimab: an anti-PD-1/CTLA-4 bispecific antibody (an agent that combines immunotherapies like Keytruda and Yervoy in only one drug).
有用链接
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10012886/ https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00411-4/fulltext| 地点 | 位置状态 |
|---|---|
| 中国 | |
|
The Sixth Affiliated Hospital of Sun Yat-sen University 广东广州 510655 |
招聘 |
联系方式
联系
纳入标准
纳入标准
1. Willing and able to provide written informed consent.
2. Histological or cytological documentation of adenocarcinoma of the colon or rectum.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
4. Tumor tissues were identified as mismatch repair-deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR).
5. Subjects with stage IV colorectal cancer must have measurable or non measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1.
6. Previous treatment with an anti-PD-1 or PD-L1 monoclonal antibody for advanced or metastatic colorectal cancer has failed. Treatment failure was defined as: disease progression or unacceptable toxicity during treatment or within 6 months after the last treatment.
7. Adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol.
排除标准
排除标准：
1. Previously received anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T-lymphocyte-associated Protein 4, CTLA-4) antibody.
2. Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.
3. Heart failure grade III/IV (NYHA-classification).
4. Unresolved toxicity higher than CTCAE v.5.0 Grade 1 attributed to any prior therapy/procedure.
5. Subjects with known allergy to the study drugs or to any of its excipients.
6. Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
7. Breast- feeding or pregnant women.
8. Lack of effective contraception.
