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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Sintilimab, Bevacizumab, Pemetrexed, and Cisplatin for Unresectable MPeM

A Single-Arm, Phase II Clinical Study of Sintilimab and Bevacizumab Combined With Pemetrexed and Cisplatin for Unresectable Malignant Peritoneal Mesothelioma

Sintilimab, Bevacizumab, Pemetrexed, and Cisplatin for Unresectable MPeM (NCT06543069) is a Phase 2 interventional studying Malignant Peritoneal Mesothelioma, Advanced, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Malignant Peritoneal Mesothelioma, Advanced and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 28 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Fully understand the study and voluntarily sign the willing to sign a consent form form; 2. Age ≥18 years old; 3. Pathologically (including histologically or cytologically) confirmed as peritoneal mesothelioma; 4. You should be able to carry out daily activities with 0 level of ability (ECOG 0)-1; 5. Expected survival of ≥3 months; 6. 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; platelet count at least 100×10\^9/L; blood count (hemoglobin) at least 90g/L; Total bilirubin \<1.5 times the upper limit of normal (ULN); ALT and AST \<2.5×ULN, GPT ≤1.5×ULN; Serum creatinine ≤1×ULN; Creatinine clearance rate \>60 ml/min (Cockcroft-Gault formula); 7. 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 medication; for men, must be surgically sterilized or agree to use appropriate contraception during the trial and for 8 weeks after the last dose of trial medication; 8. Have not participated in other clinical studies within 4 weeks before enrollment and during treatment. - Who Should NOT Join This Trial: 1. Unable to adhere to the study protocol or procedures; 2. Vaccination with live vaccines within 4 weeks before enrollment or expected during the study period; 3. Other malignancies within the past 5 years, except for cured basal or squamous cell skin cancer, thyroid papillary carcinoma, or in situ cervical cancer; 4. Active autoimmune conditions (where your immune system attacks your own body)s or a history of autoimmune conditions (where your immune system attacks your own body)s within 4 weeks prior to enrollment; 5. Previous allogeneic bone marrow or organ transplantation; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Fully understand the study and voluntarily sign the informed consent form; 2. Age ≥18 years old; 3. Pathologically (including histologically or cytologically) confirmed as peritoneal mesothelioma; 4. ECOG performance status of 0-1; 5. Expected survival of ≥3 months; 6. 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 ≥100×10\^9/L; Hemoglobin ≥90g/L; Total bilirubin \<1.5 times the upper limit of normal (ULN); ALT and AST \<2.5×ULN, GPT ≤1.5×ULN; Serum creatinine ≤1×ULN; Creatinine clearance rate \>60 ml/min (Cockcroft-Gault formula); 7. 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 medication; for men, must be surgically sterilized or agree to use appropriate contraception during the trial and for 8 weeks after the last dose of trial medication; 8. Have not participated in other clinical studies within 4 weeks before enrollment and during treatment. - Exclusion Criteria: 1. Unable to adhere to the study protocol or procedures; 2. Vaccination with live vaccines within 4 weeks before enrollment or expected during the study period; 3. Other malignancies within the past 5 years, except for cured basal or squamous cell skin cancer, thyroid papillary carcinoma, or in situ cervical cancer; 4. Active autoimmune diseases or a history of autoimmune diseases within 4 weeks prior to enrollment; 5. Previous allogeneic bone marrow or organ transplantation; 6. Serious cardiovascular diseases within 6 months prior to enrollment, including unstable angina or myocardial infarction; 7. Allergy to study drugs or any of their excipients; 8. International Normalized Ratio (INR) \>1.5 or Partial Thromboplastin Time (APTT) \>1.5×ULN; 9. Electrolyte abnormalities of clinical significance as judged by the investigator; 10. Uncontrolled hypertension before enrollment, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg; 11. 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 thromboembolic event (including stroke and/or transient ischemic attack) within the past 12 months; 12. 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 failure New York Heart Association (NYHA) class \>2; ventricular arrhythmias requiring medication; Left Ventricular Ejection Fraction (LVEF) \<50%; 13. Active or uncontrolled severe infections (≥CTCAE v5.0 Grade 2); 14. Known Human Immunodeficiency Virus (HIV) infection. Clinically significant liver disease history, including viral hepatitis \[active Hepatitis B Virus (HBV) infection must be excluded, i.e., HBV DNA positive (\>1×10\^4 copies/mL or \>2000 IU/mL); known Hepatitis C Virus (HCV) infection and HCV RNA positive (\>1×10\^3 copies/mL)\]; 15. 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., requiring treatment for epilepsy), could interfere with the interpretation of study results, or place the patient at high risk; 16. Urinalysis indicating urine protein ≥2+ and 24-hour urine protein \>1.0g; 17. 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); 18. Patients deemed unsuitable for the study by the investigator.

Treatments Being Tested

DRUG

Sintilimab, Bevacizumab , Pemetrexed , Cisplatin

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Cancer Institute and Hospital,Chinese Academy of Medical Sciences
Beijing, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06543069), the sponsor (Cancer Institute and Hospital, Chinese Academy of Medical Sciences), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06543069 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06543069?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06543069?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06543069. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06543069. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.