The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Locally Advanced Rectal Cancer (TORCH）
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- STATUS
- Recruiting
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- End date
- Dec 31, 2023
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- participants needed
- 130
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- sponsor
- Fudan University
Summary
The study evaluates the combination of immunotherapy of PD-1 antibody and neoadjuvant short-course radiotherapy in locally advanced rectal cancer (LARC). Patients are randomly assigned into two prospective cohorts: consolidation cohort and induction cohort. Consolidation cohort: A total of 65 patients will receive 55Gy short-course radiotherapy, followed by 6 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the total mesorectal excision (TME). Induction cohort: A total of 65 patients will firstly receive 2 cycles of CAPOX chemotherapy and PD-1 antibody, then receive 55Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TME surgery. The rate of pathological complete response (pCR), long-term prognosis and adverse effects will be analyzed.
Details
| Condition | Locally Advanced Rectal Cancer |
|---|---|
| Treatment | Capecitabine, Oxaliplatin, PD-1 antibody, Short-course Radiotherapy |
| Clinical Study Identifier | NCT04518280 |
| Sponsor | Fudan University |
| Last Modified on | 4 October 2022 |
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