Who is sponsoring NCT05035381?

NCT05035381 is sponsored by Tianjin Medical University Cancer Institute and Hospital.

What drugs are being tested in NCT05035381?

Interventions in NCT05035381: Pembrolizumab (PD-1 Inhibitor) Combined With Bevacizumab and FOLFIRI Regimen.

What condition does NCT05035381 study?

NCT05035381 studies MSI-H Advanced Colorectal Cancer.

Is NCT05035381 still recruiting?

NCT05035381 is currently status unknown. Last updated 5 September 2021.

Last reviewed 2021-09-05 · How we verify

NCT05035381

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

PD-1 Inhibitor Combined With Bevacizumab and FOLFIRI Regimen in the Second-line Treatment of Advanced Colorectal Cancer

Status unknown Phase 2 Last updated 5 September 2021

What this trial tests

Phase 2 trial testing Pembrolizumab (PD-1 Inhibitor) Combined With Bevacizumab and FOLFIRI Regimen in MSI-H Advanced Colorectal Cancer in 10 participants. Status unknown.

Timeline

1 January 2019

Primary endpoint
30 December 2022

30 December 2022

Quick facts

Lead sponsor	Tianjin Medical University Cancer Institute and Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 January 2019
Primary completion	30 December 2022
Estimated completion	30 December 2022
Sites	1 location across China

Drugs / interventions tested

Pembrolizumab (PD-1 Inhibitor) Combined With Bevacizumab and FOLFIRI Regimen — full drug profile →

Conditions studied

MSI-H Advanced Colorectal Cancer — all drugs for MSI-H Advanced Colorectal Cancer →

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Who can join

Adults 18 to 75, any sex, with MSI-H Advanced Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

MSI-H is a biomarker for solid tumors benefiting from immunotherapy. Recent clinical studies have confirmed that PD-1 inhibitors have a good effect on MSI-H advanced colorectal cancer for first- or second-line treatment. The overall effective rate is 30% to 40%. However, about 30% of patients are resistant to PD-1 inhibitors. Whether PD-1 inhibitors and existing chemotherapeutics and anti-vascular drugs have synergistic effects is worth studying. This study is a phase II prospective clinical study of PD-1 inhibitor combined with bevacizumab and FOLFIRI regimen in the second-line treatment of unresectable recurrent or metastatic MSI-H colorectal cancer.

Publications & conference data

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

Challenges and Therapeutic Opportunities in the dMMR/MSI-H Colorectal Cancer Landscape.
Mulet-Margalef N, Linares J, Badia-Ramentol J, Jimeno M, et al · · 2023 · cited 55× · PMID 36831367 · DOI 10.3390/cancers15041022
Unraveling Resistance to Immunotherapy in MSI-High Colorectal Cancer.
Heregger R, Huemer F, Steiner M, Gonzalez-Martinez A, et al · · 2023 · cited 32× · PMID 37894457 · DOI 10.3390/cancers15205090
Exploring Predictive and Prognostic Biomarkers in Colorectal Cancer: A Comprehensive Review.
Ashouri K, Wong A, Mittal P, Torres-Gonzalez L, et al · · 2024 · cited 14× · PMID 39199569 · DOI 10.3390/cancers16162796
Intrinsic resistance and efficacy of immunotherapy in microsatellite instability-high colorectal cancer: A systematic review and meta-analysis.
Wang R, Lian J, Wang X, Pang X, et al · · 2023 · cited 14× · PMID 36408953 · DOI 10.17305/bjbms.2022.8286
The Interplay between Anti-Angiogenics and Immunotherapy in Colorectal Cancer.
Maiorano BA, Parisi A, Maiello E, Ciardiello D. · · 2022 · cited 7× · PMID 36294987 · DOI 10.3390/life12101552
Mechanisms of Anti-PD Therapy Resistance in Digestive System Neoplasms.
Wu Y, Jiang X, Yu Z, Xing Z, et al · · 2025 · PMID 38305306 · DOI 10.2174/0115748928269276231120103256

Verify or expand the search:

Other Tianjin Medical University Cancer Institute and Hospital trials

Trials by the same sponsor.

NCT07493993 — Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Nab-Paclitaxel in Neoa · Phase 2 · not yet recruiting
NCT07515469 — A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With QL1706, an Anti-PD · Phase 2 · not yet recruiting
NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence · Phase 3 · not yet recruiting
NCT07510594 — A Phase II Study of Benmelstobart + Anlotinib + Chemotherapy as First-Line Treatment for LCNEC and EP-NEC · Phase 2 · not yet recruiting
NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure · Phase 2 · 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 NCT05035381 (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 Tianjin Medical University Cancer Institute and Hospital
Last refreshed: 5 September 2021

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/NCT05035381.

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