drugset / Trial / NCT05809336

Gut Microbial Metabolites Inosine Combined With PD-1/PD-L1 Inhibitor for Patients With Malignant Advanced Solid Tumors

NCT05809336

Phase 2/3 Completed 172 enrolled Beijing Friendship Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

We conducted a single-center, prospective randomized ,Parallel controls, open labels Clinical Studies,The study is about Gut Microbial Metabolites Inosine Combined With PD-1/PD-L1 Inhibitor for Patients with malignant Advanced Solid Tumors .One group was the inosine group , the other group was the non-inosine group.The treatment regimen of inosine group : inosine + PD-1/PD-L1 inhibitor ± chemotherapy/targeting, and the treatment regimen of non-inosine group : PD-1/PD-L1 inhibitor ± chemotherapy/targeting.The primary study endpoints were overall survival (OS) and progression-free survival PFS, and the secondary study endpoints were objective remission rate (ORR) and disease control rate (DCR) comparing the two groups.

Timeline

Start
2019-05-01
Primary completion
2022-10-31
Completion
2022-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Inosine Unknown 0.2 g Oral
Background Atezolizumab Monoclonal antibody
Background Camrelizumab Monoclonal antibody
Background Pembrolizumab Monoclonal antibody
Background Penpulimab Monoclonal antibody
Background Sintilimab Monoclonal antibody
Background Tislelizumab Monoclonal antibody
Background Toripalimab Monoclonal antibody

Indications