About this trial
This is a randomized, open-label, multicenter, phase III clinical study. The aim is to evaluate the efficacy of JMT101 in combination with irinotecan in the third-line and beyond treatment of Metastatic Colorectal Cancer.
Eligibility criteria
Qualifiers
1. Age ranged from 18 to 75 years old (inclusive), regardless of gender;
2. Pathological diagnosis as metastatic colorectal adenocarcinoma, with RAS and BRAF wild-type and non-dMMR/MSI-H;
3. Tumor tissue available for central laboratory testing;
4. Metastatic colorectal cancer with disease progression after 2nd line treatment; previously received standard chemotherapy based on fluorouracil, oxaliplatin, irinotecan; patients are allowed to previously receive EGFR and/or VEGF inhibitors, but not allowed to previously receive regorafenib, fruquintinib;
Disqualifiers
1. Participants who have been systematically treated with an EGFR inhibitor (such as cetuximab) within 4 months prior to the first dose of study drug.
2. Central nervous system metastasis or meningeal metastasis;
3. Patients with high risk of bleeding due to tumor invasion of important arteries;
4. Uncontrolled or requiring repeated drainage of pleural effusion, pericardial effusion, or abdominal effusion;
Trial design
Treatments tested in this trial
- JMT101
- Irinotecan
- Regorafenib