The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSI-H Locally Advanced Rectal Cancer

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

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. UGT1A1*28 6/6 or 6/7

8. the MSI status is MSI-H or d-MMR

9. without previous anti-cancer therapy or immunotherapy

10. with good compliance

11. 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. UGT1A1*28 7/7

8. the MSI status is MSS or p-MMR

9. allergic to any component of the therapy