NCT05839470 is a Phase 2 clinical trial of cadonilimab in Colorectal Cancer, sponsored by Fujian Cancer Hospital.

Who is sponsoring NCT05839470?

NCT05839470 is sponsored by Fujian Cancer Hospital.

What drugs are being tested in NCT05839470?

Interventions in NCT05839470: cadonilimab, irinotecan, Oxaliplatin, leucovorin or levoleucovorin, 5-FU.

What condition does NCT05839470 study?

NCT05839470 studies Colorectal Cancer.

Is NCT05839470 still recruiting?

NCT05839470 is currently status unknown. Last updated 15 November 2023.

Last reviewed 2023-11-15 · How we verify

NCT05839470

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

Cadonilimab Plus FOLFOXIRI and Bevacizumab as First Line Therapy for Metastatic MSS Colorectal Cancer

Status unknown Phase 2 Last updated 15 November 2023

What this trial tests

Phase 2 trial testing cadonilimab in Colorectal Cancer in 20 participants. Status unknown.

Timeline

19 November 2023

Primary endpoint
1 March 2024

1 March 2025

Quick facts

Lead sponsor	Fujian Cancer Hospital
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	19 November 2023
Primary completion	1 March 2024
Estimated completion	1 March 2025
Sites	1 location across China

Drugs / interventions tested

cadonilimab — full drug profile →
irinotecan (irinotecan) — full drug profile →
Oxaliplatin (Oxaliplatin) — full drug profile →
leucovorin or levoleucovorin
5-FU

Conditions studied

Colorectal Cancer — all drugs for Colorectal Cancer →

Sponsor

Fujian Cancer Hospital

Who can join

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

Sponsor's own description

Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors. This was a phase II study of cadonilimab in combination with bevacizumab and FOLFOXIRI as first line therapy for metastatic microsatellite stable (MSS) colorectal cancer. The goal of this clinical trial is to evaluated the efficacy and safety.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Current and emerging concepts for systemic treatment of metastatic colorectal cancer.
Steup C, Kennel KB, Neurath MF, Fichtner-Feigl S, et al · · 2025 · cited 10× · PMID 41047178 · DOI 10.1136/gutjnl-2025-335412

Verify or expand the search:

Other trials of cadonilimab

Trials testing the same drug.

NCT06577961 — Vorolanib Combined With Cadonilimab in the Treatment of Untreated Advanced RCC Patients · Phase 1, PHASE2 · not yet recruiting
NCT06650332 — Cadonilimab Combination Regimen as First-line Treatment for HER2-expressing GC/GEJ Patients · Phase 1, PHASE2 · recruiting
NCT06145308 — Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing · Phase 2 · recruiting
NCT05737368 — Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab · Phase 1 · unknown

Other recruiting trials for Colorectal Cancer

Currently open trials in the same condition.

NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · recruiting

Other Fujian Cancer Hospital trials

Trials by the same sponsor.

NCT07470840 — SBRT Plus Anlotinib and Bimepolizumab in Locally Advanced or Metastatic Renal Cell Carcinoma · Phase 2 · not yet recruiting
NCT07469306 — Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer · Phase 2 · not yet recruiting
NCT07492654 — Clinical Study on the Prevention and Treatment of Radiation Vaginitis With Triethanolamine Cream · Phase 4 · not yet recruiting
NCT07399158 — CROSSROAD: Treatment Regimen Switch - Re-induction Chemotherapy vs. Direct Radiotherapy in LANPC With Inadequate Respons · not yet recruiting
NCT07256236 — SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer · 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 NCT05839470 (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 Fujian Cancer Hospital
Last refreshed: 15 November 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/NCT05839470.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing