NCT05809336

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. A total of 172 patients with advanced malignant solid tumors were collected from Capital Medical University Beijing Friendship Hospital, and randomly assigned to two groups according to 1:1, 86 patients in the inosine group and 86 patients in the non-inosine group. The regimen of inosine treatment group was: inosine + PD-1/PD-L1 inhibitor ± chemotherapy/targeting, and the treatment regimen of non-inosine treatment group was: PD-1/PD-L1 inhibitor ±chemotherapy/targeting,every 2 or 3 weeks protocol ,until the subject's disease progresses, death, intolerable adverse events, the investigator determines that there is no benefit from continued treatment or other termination criteria are met (pregnancy, individual patient reasons or co-morbidities), the subject requests withdrawal from the study, withdrawal of informed consent, and loss of visit.Anti-tumor efficacy is evaluated every 2/3 cycles (every 6 weeks) based on computed tomography (CT) or magnetic resonance imaging (MRI) results and their tumor markers, according to RECIST v1.1 criteria. Inosine tablets were purchased from Tianjin Jinshi, dosage: 0.2g orally 3 times/day, PD-1/PD-L1 inhibitors, chemotherapy and targeted combination therapy regimens were developed by the investigators according to the NCCN guidelines and CSCO guidelines and the patient's condition and its staging.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Inosine 0.2g orally 3 times/day	inosine + PD-1/PD-L1 inhibitor ± chemotherapy/targeting,
DRUG	PD-1/PD-L1 inhibitor ,chemotherapy/targeting	PD-1/PD-L1 inhibitor ± chemotherapy/targeting

Timeline

• Start date: 2019-05-01
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2023-04-12
• Last updated: 2023-04-12

Locations

1 site across 1 country: China