drugset / Trial / NCT04711434
PD-1 Antibody for The Prevention of Adenomatous Polyps and Second Primary Tumors in Lynch Syndrome Patients
Phase 3
Unknown
260 enrolled
Sun Yat-sen University
Fujian Cancer Hospital · collabGuangdong Provincial Hospital of Traditional Chinese Medicine · collabGuangdong Provincial People's Hospital · collabSecond Affiliated Hospital, School of Medicine, Zhejiang University · collabThe Third Affiliated Hospital of Kunming Medical College. · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
This study aims to explore the role of PD-1 Antibody in preventing adenomatous polyps and second primary tumors in patients with Lynch Syndrome. There two arms, one is the experimental arm (PD-1 antibody prevention group) and the other is the control arm (routine follow-up group). For the experimental group, Tripleitriumab (PD-1 antibody) is given every 3 months for a year.
Timeline
- Start
- 2020-11-01
- Primary completion
- 2023-12-31
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |