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To explore the efficacy and safety of sintilimab, bevacizumab combined with pemetrexed and cisplatin in the treatment of malignant peritoneal mesothelioma, and to explore the biomarkers related to efficacy or safety.
This single-arm study aims to enroll 28 patients with unresectable malignant peritoneal mesothelioma. Enrolled patients will undergo treatment with sintilimab (200 mg), bevacizumab (7.5 mg/kg), pemetrexed (500 mg/m^2), and cisplatin (75 mg/m^2) administered every three weeks. Tumor assessments will be performed every two cycles according to RECIST 1.1 criteria, and after six cycles, maintenance therapy with sintilimab, bevacizumab, and pemetrexed will continue until disease progression or unacceptable toxicity occurs. The primary outcome measure of the study is Progression-Free Survival (PFS), while secondary outcomes include Overall Survival (OS), Objective Response Rate (ORR), and Disease Control Rate (DCR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | Sintilimab and Bevacizumab Combined with Pemetrexed and Cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab, Bevacizumab , Pemetrexed , Cisplatin | Drug | Sintilimab: 200mg, bevacizumab: 7.5mg/kg, pemetrexed: 500mg/m2, cisplatin: 75mg /m2, Q3w. Tumor assessments will be performed every two cycles according to RECIST 1.1 criteria. After 6 cycles, maintenance therapy with sintilimab, bevacizumab, and pemetrexed will continue until disease progression or unacceptable toxicity occurs. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | The time from the date of first administration of this regimen to the date of first documented disease progression or death due to any cause. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | The time from the initiation of the first dose of medication in a patient to death from any cause. | 36 months |
| Objective Response Rate (ORR) | The proportion of patients with a comfirmed complete response or patial response using RECIST1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongkun Sun | Contact | 13141276041 | hsunyk@cicams.ac.cn | |
| Yuting Fang | Contact | 13700902492 | fangyuting502@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongkun Sun, Doctor | Cancer Institute and Hospital, Chinese Academy of Medical SciencesCancer | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital,Chinese Academy of Medical Sciences | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| D000068258 | Bevacizumab |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
|
| 36 months |
| Disease Control Rate (DCR) | The percentage of patients who have achieved complete response, partial response, and stable disease to the treatment, as defined by RECIST 1.1 criteria. | 36 months |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |