The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer (TORCH-E）

• Status: Not yet recruiting
• Trial end date: 2025-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The study evaluates the combination of immunotherapy of PD-1 antibody and neoadjuvant short-course radiotherapy in early low rectal cancer. A total of 34 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the local excision(TEM) or total mesorectal excision (TME). The rate of complete response (CR, pCR + sustained cCR for ≥ 1 year), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Antibodies; Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

1. age 18-70 years old, female and male

2. pathological confirmed adenocarcinoma

3. clinical stage T1-3bN0, tumor maximum diameter less than 4cm

4. the distance from anal verge less than 5 cm

5. without distance metastases

6. KPS >=70

7. with good compliance

8. microsatellite repair status is MSS/pMMR

9. without previous anti-cancer therapy or immunotherapy

10. signed the inform consent

Exclusion Criteria:

1. pregnancy or breast-feeding women

2. pathological confirmed signet ring cell carcinoma

3. clinical stage T1N0 and can be resected locally

4. history of other malignancies within 5 years

5. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.

6. immunodeficiency disease or long-term using of immunosuppressive agents

7. baseline blood and biochemical indicators do not meet the following criteria:

neutrophils≥1.5×10^9/L, Hb≥90g/L, PLT≥100×10^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN

8. DPD deficiency

9. allergic to any component of the therapy