Last reviewed · How we verify
NCT05815290
Cadonilimab in Locally Advanced MSI-H/dMMR Colorectal Cancer
Phase 2 trial testing Cadonilimab in dMMR Colorectal Cancer in 50 participants. Status unknown.
30 September 2024
Quick facts
| Lead sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 29 March 2023 |
| Primary completion | 30 September 2024 |
| Estimated completion | 30 March 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Cadonilimab — full drug profile →
Conditions studied
- dMMR Colorectal Cancer — all drugs for dMMR Colorectal Cancer →
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Who can join
18 and older, any sex, with dMMR Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a two-arm phase II clinical study to evaluate the efficacy and safety of Cadonilimab (a PD-1/CTLA-4 bispecific antibody) in MSI-H/dMMR locally advanced colorectal cancer as the regimen of neoadjuvant treatment. Eligible patients will receive Cadonilimab monotherapy for eight cycles before surgery and part of patients may exempt from surgery.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Beyond PD(L)-1 Blockade in Microsatellite-Instable Cancers: Current Landscape of Immune Co-Inhibitory Receptor Targeting.
Crimini E, Boscolo Bielo L, Berton Giachetti PPM, Pellizzari G, et al · · 2024 · cited 5× · PMID 38254772 · DOI 10.3390/cancers16020281 -
Clinical status and future prospects of neoadjuvant immunotherapy for localized mismatch repair-deficient cancers: a review.
Li J. · · 2024 · cited 3× · PMID 38768473 · DOI 10.1097/js9.0000000000001680 -
Biology and evolving management of resectable dMMR/MSI-H cancers: current status and future perspectives.
Tanegashima T, Shiota M, Toyosaki K, Funakoshi K, et al · · 2025 · cited 1× · PMID 41196394 · DOI 10.1007/s00262-025-04223-9 -
Case report: Efficacy of immunotherapy as conversion therapy in dMMR/MSI-H colorectal cancer: a case series and review of the literature.
San-Román-Gil M, Martínez-Delfrade I, Albarrán-Fernández V, Guerrero-Serrano P, et al · · 2024 · cited 1× · PMID 38361927 · DOI 10.3389/fimmu.2024.1352262
Verify or expand the search:
- PubMed search for NCT05815290
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cadonilimab
Trials testing the same drug.
- NCT07446257 — THIO and Cadonilimab in Resectable Hepatocellular Carcinoma · EARLY_PHASE1 · not yet recruiting
- NCT07243951 — Phase II Clinical Study on the Efficacy and Safety of the Combination of Cadonilimab and Capecitabine in Adjuvant Therap · Phase 2 · not yet recruiting
- NCT06913218 — A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically R · Phase 1 · not yet recruiting
- NCT06940921 — SBRT-LDRT-Cadonilimab for Advanced Gastric, Colorectal and Ovarian Cancers With Peritoneal Metastases · Phase 1, PHASE2 · active not recruiting
- NCT06789848 — Ligufalimab and Cadonilimab in Advanced Liver Cancers · Phase 2 · recruiting
Other recruiting trials for dMMR Colorectal Cancer
Currently open trials in the same condition.
- NCT06613165 — Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer · recruiting
- NCT05239546 — Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers · Phase 2 · recruiting
Other Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials
Trials by the same sponsor.
- NCT07531563 — Protein Supplementation for Radiation- Induced Oral Mucositis in Head and Neck Cancer Patients Receiving Radiotherapy · NA · not yet recruiting
- NCT07537049 — BR101 in Patients With Relapsed/Refractory Multiple Myeloma · Phase 1 · not yet recruiting
- NCT07187154 — The Application of Symptoms Management Program Based on the Patient Reported Outcome After Esophagectomy · NA · not yet recruiting
- NCT07530549 — A Phase II Single-arm Clinical Study in the Treatment of Locally Advanced Esophageal Cancer After Failed Neoadjuvant Che · Phase 2 · not yet recruiting
- NCT07507058 — Hypofractionated Radiotherapy for Postoperative Intermediate-Risk Head and Neck Squamous Cell Carcinoma · 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 NCT05815290 (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 Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Last refreshed: 18 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/NCT05815290.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing