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.
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;
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;
Parallel
JMT101
DrugJMT101, 6 mg/kg, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks).
Irinotecan
DrugIrinotecan, 180mg/m\^2, administered by IV infusion once every two weeks (one treatment cycle is 4 weeks).
Regorafenib
DrugRegorafenib, 160 mg, taken orally once daily for the first 21 days of each 28-day cycle.
Progression-free Survival (PFS)
defined as the time from randomization to the first occurrence of disease progression as determined by the BIRC with use of RECIST v1.1 or death from any cause, whichever occurs first.
Overall response rate (ORR)
determined by the BIRC and investigator with use of RECIST v1.1
Disease Control Rate (DCR)
determined by the BIRC and investigator with use of RECIST v1.1
Duration of response (DOR)
determined by the BIRC and investigator with use of RECIST v1.1
Progression-free Survival (PFS)
defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.
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This trial is not recruiting at the moment. You can still explore other options:
