Who is sponsoring NCT05809336?

NCT05809336 is sponsored by Beijing Friendship Hospital.

What drugs are being tested in NCT05809336?

Interventions in NCT05809336: Inosine 0.2g orally 3 times/day, PD-1/PD-L1 inhibitor ,chemotherapy/targeting.

What condition does NCT05809336 study?

NCT05809336 studies Advanced Solid Tumor.

Is NCT05809336 still recruiting?

NCT05809336 is currently completed. Last updated 12 April 2023.

Last reviewed 2023-04-12 · How we verify

NCT05809336

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2, PHASE3 Last updated 12 April 2023

What this trial tests

Phase 2, PHASE3 trial testing Inosine 0.2g orally 3 times/day in Advanced Solid Tumor in 172 participants. Completed in 31 October 2022.

Timeline

1 May 2019

Primary endpoint
31 October 2022

31 October 2022

Quick facts

Lead sponsor	Beijing Friendship Hospital
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	172
Start date	1 May 2019
Primary completion	31 October 2022
Estimated completion	31 October 2022
Sites	1 location across China

Drugs / interventions tested

Inosine 0.2g orally 3 times/day — full drug profile →
PD-1/PD-L1 inhibitor ,chemotherapy/targeting — full drug profile →

Conditions studied

Advanced Solid Tumor — all drugs for Advanced Solid Tumor →

Sponsor

Beijing Friendship Hospital

Who can join

Adults 18 to 75, any sex, with Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Redefining bioactive small molecules from microbial metabolites as revolutionary anticancer agents.
Giurini EF, Godla A, Gupta KH. · · 2024 · cited 15× · PMID 38200347 · DOI 10.1038/s41417-023-00715-x
Inosine enhances the efficacy of immune-checkpoint inhibitors in advanced solid tumors: A randomized, controlled, Phase 2 study.
Zhao H, Zhang W, Lu Y, Dong Y, et al · · 2024 · cited 10× · PMID 39267574 · DOI 10.1002/cam4.70143
Microbial metabolite-driven immune reprogramming in tumor immunotherapy: mechanisms and therapeutic perspectives.
Lu Y, Yuan H, Liang S, Li D, et al · · 2025 · cited 1× · PMID 41181090 · DOI 10.3389/fimmu.2025.1603658

Verify or expand the search:

Other recruiting trials for Advanced Solid Tumor

Currently open trials in the same condition.

NCT07300943 — Study in Advanced Solid Tumor Patients · Phase 1, PHASE2 · recruiting
NCT07304128 — A Study of PLB-002 in Advanced Solid Tumors · Phase 1 · recruiting
NCT07213830 — A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Anti-tumour Activity · Phase 1, PHASE2 · recruiting
NCT07226349 — A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors · Phase 1 · recruiting
NCT07222267 — An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Soli · Phase 1 · recruiting

Other Beijing Friendship Hospital trials

Trials by the same sponsor.

NCT07453862 — Novel Calcium Channel Modulators in RLS and Variants: Efficacy & Safety · Phase 1 · recruiting
NCT07397442 — Short-Course Radiotherapy Combined With Chemotherapy and Immunotherapy in Mid-Low Locally Advanced Rectal Cancer · Phase 2 · not yet recruiting
NCT07393048 — Application and Exploration of Personalized ctDNA-MRD Detection Technology in Predicting the Efficacy of Neoadjuvant The · recruiting
NCT07441850 — Digital Rehabilitation for Gastric Cancer Surgery After Neoadjuvant Therapy · NA · recruiting
NCT07369739 — Golidocitinib Combined With Selinexor for CAEBVD · Phase 2, PHASE3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05809336 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Beijing Friendship Hospital
Last refreshed: 12 April 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05809336.

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