Trials / Recruiting
RecruitingNCT05890742
A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer
A Phase 1b/3 Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Evaluate efficacy and safety of IBI310 (CTLA-4 antibody) in combination with Sintilimab, for neoadjuvant treatment of MSI-H/dMMR resectable colon cancer
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sintilimab | In ARM Phase Ib Control group, Sintilimab will be used twice, q3w. |
| DRUG | IBI310&Sintilimab | In ARM Phase Ib\&III Experimental group，IBI310\&Sintilimab will be used in first cycle, Sintilimab will be used in second cycle(q3w). Radical surgery after neoadjuvant therapy. |
| PROCEDURE | Radical surgery | In ARM Phase Ib\&III Experimental group, Phase Ib Control group, subjects will receive radical surgery after neoadjuvant therapy. In ARM Phase III Control group,subjects will receive radical surgery without neoadjuvant therapy |
Timeline
- Start date
- 2023-05-25
- Primary completion
- 2028-04-15
- Completion
- 2028-07-15
- First posted
- 2023-06-06
- Last updated
- 2024-03-15
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05890742. Inclusion in this directory is not an endorsement.