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MSI-H is a biomarker for solid tumors benefiting from immunotherapy. Recent clinical studies have confirmed that PD-1 inhibitors have a good effect on MSI-H advanced colorectal cancer for first- or second-line treatment. The overall effective rate is 30% to 40%. However, about 30% of patients are resistant to PD-1 inhibitors. Whether PD-1 inhibitors and existing chemotherapeutics and anti-vascular drugs have synergistic effects is worth studying. This study is a phase II prospective clinical study of PD-1 inhibitor combined with bevacizumab and FOLFIRI regimen in the second-line treatment of unresectable recurrent or metastatic MSI-H colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experiment Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab (PD-1 Inhibitor) Combined With Bevacizumab and FOLFIRI Regimen | Drug | MSI-H colorectal cancer, recurrence and metastasis within 1 year after surgery, or failure of first-line oxaliplatin and fluorouracil chemotherapy for advanced colorectal cancer, PD-1 inhibitors combined with bevacizumab and FOLFIRI regimen |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate | Up to 2 years | |
| Progression-free survival | up to 2 years | |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongli Li, Dr. | Contact | 86-22-23340123 | 1051 | hongli@126.com |
| Tao Ning, Dr. | Contact | 86-22-23340123 | 1051 | ningtao37@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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|
|
| up to 3 years |
| Adverse Events | up to one year |
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D000082082 | Immune Checkpoint Inhibitors |
| D000068258 | Bevacizumab |
| D000077146 | Irinotecan |
| D005472 | Fluorouracil |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
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