Actively Recruiting
Sintilimab, Bevacizumab, Pemetrexed, and Cisplatin for Unresectable MPeM
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-08-07
28
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sintilimab, Bevacizumab, Pemetrexed, and Cisplatin for Unresectable MPeM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study and voluntarily sign the informed consent form
- Age 18 years or older
- Pathologically confirmed peritoneal mesothelioma
- ECOG performance status of 0 to 1
- Expected survival of at least 3 months
- Adequate vital organ function including specified blood counts and liver, kidney function
- Women of childbearing potential must have a negative pregnancy test within 7 days before enrollment and agree to use contraception during the trial and for 8 weeks after last dose
- Men must be surgically sterilized or agree to use contraception during the trial and for 8 weeks after last dose
- No participation in other clinical studies within 4 weeks before enrollment and during treatment
You will not qualify if you...
- Unable to follow study protocol or procedures
- Vaccination with live vaccines within 4 weeks before enrollment or expected during the study
- Other malignancies within past 5 years except cured basal or squamous cell skin cancer, thyroid papillary carcinoma, or in situ cervical cancer
- Active or recent autoimmune diseases within 4 weeks before enrollment
- Previous allogeneic bone marrow or organ transplantation
- Serious cardiovascular diseases within 6 months prior to enrollment including unstable angina or recent myocardial infarction
- Allergy to study drugs or their ingredients
- Abnormal blood clotting tests (INR >1.5 or APTT >1.5 times upper limit)
- Significant electrolyte imbalances
- Uncontrolled hypertension (systolic ≥140 mmHg or diastolic ≥90 mmHg)
- Recent significant bleeding or thromboembolic events
- Significant cardiovascular conditions including heart failure NYHA class >2, ventricular arrhythmias, or low heart ejection fraction
- Active or uncontrolled severe infections
- Known HIV infection or active hepatitis B or C infections
- Any other serious diseases or conditions that could affect study safety or results
- Significant proteinuria
- Long-term use of immunosuppressive drugs or corticosteroids exceeding specified doses
- Deemed unsuitable for the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Institute and Hospital,Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
Y
Yongkun Sun
CONTACT
Y
Yuting Fang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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