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New treatment option for Malignant Peritoneal Mesothelioma, Advanced
Official title Sintilimab, Bevacizumab, Pemetrexed, and Cisplatin for Unresectable MPeM
ClinicalTrials.gov ID: NCT06543069
What this study is testing
What is Sintilimab, Bevacizumab , Pemetrexed , Cisplatin?
Sintilimab, Bevacizumab , Pemetrexed , Cisplatin is an investigational medicine, being studied as a potential treatment for malignant peritoneal mesothelioma, advanced.
Also referred to as Sintilimab+Bevacizumab+Pemetrexed+ Cisplatin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Fully understand the study and voluntarily sign the informed consent form;
- Age ≥18 years old;
- Pathologically (including histologically or cytologically) confirmed as peritoneal mesothelioma;
- ECOG performance status of 0-1;
- Expected survival of ≥3 months;
You likely can't join if
- Unable to adhere to the study protocol or procedures;
- Vaccination with live vaccines within 4 weeks before enrollment or expected during the study period;
- Other malignancies within the past 5 years, except for cured basal or squamous cell skin cancer, thyroid papillary carcinoma, or in situ cervical...
- Active autoimmune diseases or a history of autoimmune diseases within 4 weeks prior to enrollment;
- Previous allogeneic bone marrow or organ transplantation;
- Serious cardiovascular diseases within 6 months prior to enrollment, including unstable angina or myocardial infarction;
See the full eligibility criteria
- Fully understand the study and voluntarily sign the informed consent form;
- Age ≥18 years old;
- Pathologically (including histologically or cytologically) confirmed as peritoneal mesothelioma;
- ECOG performance status of 0-1;
- Expected survival of ≥3 months;
- Function of vital organs must meet the following criteria (use of any blood products and cell growth factors is not allowed within 14 days prior to enrollment): Absolute neutrophil count ≥1.5×10\^9/L; Platelets...
- Women of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment and agree to use appropriate contraception during the trial and for 8 weeks after the last dose of trial...
- Have not participated in other clinical studies within 4 weeks before enrollment and during treatment. -
- Unable to adhere to the study protocol or procedures;
- Vaccination with live vaccines within 4 weeks before enrollment or expected during the study period;
- Other malignancies within the past 5 years, except for cured basal or squamous cell skin cancer, thyroid papillary carcinoma, or in situ cervical cancer;
- Active autoimmune diseases or a history of autoimmune diseases within 4 weeks prior to enrollment;
- Previous allogeneic bone marrow or organ transplantation;
- Serious cardiovascular diseases within 6 months prior to enrollment, including unstable angina or myocardial infarction;
- Allergy to study drugs or any of their excipients;
- International Normalized Ratio (INR) \>1.5 or Partial Thromboplastin Time (APTT) \>1.5×ULN;
- Electrolyte abnormalities of clinical significance as judged by the investigator;
- Uncontrolled hypertension before enrollment, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;
- Evidence or history of significant bleeding tendency within 3 months before enrollment (bleeding \>30 mL, including hematemesis, melena, hematochezia), hemoptysis (more than 5 mL of fresh blood within 4 weeks) or a...
- Significant cardiovascular diseases of clinical importance, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within the past 6 months; congestive heart...
- Active or uncontrolled severe infections (≥CTCAE v5.0 Grade 2);
- Known Human Immunodeficiency Virus (HIV) infection. Clinically significant liver disease history, including viral hepatitis [active Hepatitis B Virus (HBV) infection must be excluded, i.e., HBV DNA positive (\>1×10\^4...
- Any other diseases, clinically significant metabolic dysfunctions, physical examination findings, or laboratory findings that, in the judgment of the investigator, make the patient unsuitable for the study drug (e.g...
- Urinalysis indicating urine protein ≥2+ and 24-hour urine protein \>1.0g;
- Complications requiring long-term treatment with immunosuppressants or systemic or local use of immunosuppressive corticosteroids (more than 10mg/day of prednisone or equivalent therapeutic hormones);
- Patients deemed unsuitable for the study by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.