drugset / Trial / NCT07509424
Neoadjuvant Short-course Radiotherapy Followed by a Combination of Disitamab Vedotin, Sintilimab, and Capecitabine in Locally Advanced HER2-expressing Rectal Cance
Phase 2
Not yet recruiting
29 enrolled
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NaSingle-groupOpen-labelTreatment
Summary
After signing the informed consent form, patients who met the inclusion and exclusion criteria were given the full course of neoadjuvant treatment: short-term radiotherapy, followed by 6 consecutive cycles of disitamab vedotin, combined with sintilimab and capecitabine, and within 3-4 weeks after the last dose, they underwent preoperative imaging examinations to evaluate the efficacy of the neoadjuvant treatment and the possibility of total mesorectal excision. Whether adjuvant therapy was performed after surgery was determined by the investigators.
Timeline
- Start
- 2026-04-22
- Primary completion
- 2029-04-10
- Completion
- 2029-07-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | — | — |
| Subject | Disitamab Vedotin | Monoclonal antibody | — | — |
| Subject | Sintilimab | Monoclonal antibody | — | — |