Tests sintilimab and bevacizumab with chemotherapy for advanced peritoneal mesothelioma

Trial details

Who runs it

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Trial code

NCT06543069

Record updated

7 August 2024

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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 ≥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); 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; Have not participated in other clinical studies within 4 weeks before enrollment and during treatment. -.

Exclusion: Vaccination with live vaccines within 4 weeks before enrollment or expected during the study period; 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; 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; 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); Other malignancies within the past 5 years, except for cured basal or squamous cell skin cancer, thyroid papillary carcinoma, or in situ cervical cancer; Allergy to study drugs or any of their excipients; Uncontrolled hypertension before enrollment, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg; Active or uncontrolled severe infections (≥CTCAE v5.0 Grade 2); International Normalized Ratio (INR) >1.5 or Partial Thromboplastin Time (APTT) >1.5×ULN; 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%; 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)]; 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; Unable to adhere to the study protocol or procedures; Electrolyte abnormalities of clinical significance as judged by the investigator; Urinalysis indicating urine protein ≥2+ and 24-hour urine protein >1.0g; Patients deemed unsuitable for the study by the investigator.

ClinicalTrials.gov NCT06543069