drugset / Trial / NCT06829355
"Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer"
Phase 2
Recruiting
52 enrolled
Beijing Friendship Hospital
Peking Union Medical College Hospital · collabPeking University People's Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, open-label, prospective, randomized controlled Phase II clinical study. All eligible subjects will be randomly assigned in a 1:1 ratio to either the triple therapy group or the double therapy group. Triple therapy group: Subjects will receive Thymalfasin in combination with Regorafenib and Tislelizumab until iCPD is achieved per iRECIST (progressive disease (PD) per iRECIST), or until an intolerable toxicity occurs; Double therapy group: Subjects will receive Regorafenib and Tislelizumab until iCPD is achieved per iRECIST (PD per iRECIST), or until an intolerable toxicity occurs.
Timeline
- Start
- 2025-02-11
- Primary completion
- 2025-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Thymalfasin | Peptide | 4.8 mg | Subcutaneous |
| Background | Regorafenib | Small molecule | 120 mg | Oral |
| Background | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |