drugset / Trial / NCT04411524
The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSI-H Locally Advanced Rectal Cancer
NaSingle-groupOpen-labelTreatment
Summary
The study evaluates the addition of immunotherapy of PD-1 antibody in neoadjuvant chemoradiotherapy in microsatellite stability-high (MSI-H) locally advanced rectal cancer (LARC). A total of 50 MSI-H LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX. The tumor response grade, adverse effects and long-term prognosis will be analyzed.
Timeline
- Start
- 2020-07-01
- Primary completion
- 2022-04-30
- Completion
- 2022-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Capecitabine | Small molecule | 625 mg/m2 | — |
| Background | Irinotecan | Small molecule | 65 mg/m2 | — |
| Background | Irinotecan | Small molecule | 80 mg/m2 | — |
Indications
No indication recorded.