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NCT06455254
A Single-arm, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of Candonilimab（AK104） Combined With Regorafenib For the Third-line Treatment of MSS Colorectal Liver Metastasis
Phase 2 trial testing Candonilimab (AK104) in CRC in 44 participants. Currently enrolling.
1 December 2025
Quick facts
| Lead sponsor | Jin-hong Chen |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 44 |
| Start date | 11 July 2024 |
| Primary completion | 1 December 2025 |
| Estimated completion | 1 June 2026 |
| Sites | 3 locations across China |
Drugs / interventions tested
- Candonilimab (AK104) — full drug profile →
- Regorafenib — full drug profile →
Conditions studied
- CRC — all drugs for CRC →
Sponsor
Jin-hong Chen — full company profile →
Who can join
Adults 18 to 75, any sex, with CRC. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Objective Response Rate (ORR)
Time frame: 6 months
ORR, determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
Sponsor's own description
This study is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of Candonilimab (AK104) combined with Regorafenib for the treatment of MSS colorectal liver metastasis. Candonilimab (AK104) is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06455254
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT06728072 — Addition of Antibiotics to Upfront Treatment Regimen for Colorectal Cancer · Phase 2 · recruiting
- NCT06445062 — Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors · Phase 1, PHASE2 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06455254 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jin-hong Chen
- Last refreshed: 27 July 2024
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/NCT06455254.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing