The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Locally Advanced Rectal Cancer

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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 5*5Gy 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 5*5Gy 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.

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

Details

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

Criteria

Inclusion Criteria:

1. pathological confirmed adenocarcinoma

2. clinical stage T3-4 and/or N+

3. the distance from anal verge less than 12 cm

4. without distance metastases

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

6. KPS >=70

7. without previous anti-cancer therapy or immunotherapy

8. with good compliance

9. signed the inform consent

Exclusion Criteria:

1. pregnancy or breast-feeding women

2. history of other malignancies within 5 years

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

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

5. 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

6. DPD deficiency

7. allergic to any component of the therapy