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

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

Outcome

Missed primary endpoint

paper the ORR was 26.7% and 15.1%, respectively (p = 0.061). PMID 39267574 ↗

Publications

• Zhao H, Zhang W, Lu Y, Dong Y, He Z, Zhen H, Li Q. Inosine enhances the efficacy of immune-checkpoint inhibitors in advanced solid tumors: A randomized, controlled, Phase 2 study. Cancer Med. 2024 Sep;13(17):e70143. doi: 10.1002/cam4.70143.

Drugs

Indications