drugset / Trial / NCT05809336
Gut Microbial Metabolites Inosine Combined With PD-1/PD-L1 Inhibitor for Patients With Malignant Advanced Solid Tumors
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — | — |