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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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. -

Locations
Other Locations
China
Cancer Institute and Hospital,Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Yongkun Sun
hsunyk@cicams.ac.cn
13141276041
Backup
Yuting Fang
fangyuting502@163.com
13700902492
Time Frame
Start Date: 2024-01-31
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 28
Treatments
Experimental: single arm
Sintilimab and Bevacizumab Combined with Pemetrexed and Cisplatin
Related Therapeutic Areas
Sponsors
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

This content was sourced from clinicaltrials.gov