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NCT06321081
ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC
Phase 2 trial testing irinotecan, cetuximab, envafolimab in RAS Mutation in 60 participants. Currently enrolling.
14 February 2026
Quick facts
| Lead sponsor | Beijing Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 March 2024 |
| Primary completion | 14 February 2026 |
| Estimated completion | 14 August 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- irinotecan, cetuximab, envafolimab — full drug profile →
Conditions studied
- RAS Mutation — all drugs for RAS Mutation →
- Metastatic Colorectal Cancer — all drugs for Metastatic Colorectal Cancer →
- MSS — all drugs for MSS →
Sponsor
Beijing Hospital
Who can join
18 and older, any sex, with RAS Mutation or Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a non-profit phase II, open, clinical study of the combination of irinotecan plus cetuximab and envafolimab as a rechallenge regimen, in pre-treated RAS/BRAF wild type metastatic colorectal cancer patients (according to liquid biopsy at baseline). Patients have been treated in front lines with irinotecan and cetuximab and had a clinical benefit (complete or partial response) from both of them, no matter whether they had treated by any PD-1 inhibitor before.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Combination immunotherapy for colorectal cancer: Clinical applications, rationale, challenges, and future perspectives.
Fei J, Cai C, Wu W, Shen H, et al · · 2026 · PMID 41950929 · DOI 10.1016/j.xcrm.2026.102728
Verify or expand the search:
- PubMed search for NCT06321081
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for RAS Mutation
Currently open trials in the same condition.
- NCT07252479 — Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations · Phase 1 · recruiting
- NCT06218810 — Cadonilimab in Combination With Bevacizumab and FOLFOX Regimen for the First-Line Treatment of Advanced Unresectable MSS · Phase 2 · recruiting
- NCT06229340 — Leflunomide or Combination of MEK Inhibitor and Hydroxychloroquine for Refractory Patients With RAS Mutations · Phase 2 · recruiting
- NCT04776655 — Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB · Phase 3 · recruiting
- NCT04678648 — A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies · Phase 1 · recruiting
Other Beijing Hospital trials
Trials by the same sponsor.
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- NCT07295665 — External Validation of Ischemia and Hemorrhage Risk Models in Patients With Coronary Heart Disease · not yet recruiting
- NCT07143851 — Multi-modal Intelligent Diagnosis System for Multiple Ophthalmic Diseases · not yet recruiting
- NCT06955819 — GUTPROH: Probiotic-Herbal Formula for Self-Reported Constipation in Community Adults · NA · not yet recruiting
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 NCT06321081 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Hospital
- Last refreshed: 20 March 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/NCT06321081.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing