The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSS Locally Advanced Rectal Cancer

Fudan University50 enrolled

Overview

The study evaluates the addition of immunotherapy of PD-1 antibody in neoadjuvant chemoradiotherapy in microsatellite stable (MSS) locally advanced rectal cancer (LARC). A total of 50 MSS 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Locally Advanced Rectal Cancer

Interventions

PD-1 antibodyDRUG

Before neo-CRT: 2 cycles of PD-1 antibody, 240mg d1 q2w. After neo-CRT: 3 cycles of PD-1 antibody, 240mg d1 q2w.

CapecitabineDRUG

During neo-CRT: 625mg/m2 bid Monday-Friday per week

IrinotecanDRUG

During neo-CRT: 80mg/m2 qw (UGT1A1\*28 6/6) or 65mg/m2 qw (UGT1A1\*28 6/7)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 MSS or p-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 MSI-H or d-MMR 9. allergic to any component of the therapy

Locations (1)

Zhen Zhang

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Pathologic Complete Response Rate

Time frame: The pathologic complete response rate was evaluated after surgery, which was scheduled 7-8 weeks after the end of chemoradiotherapy

Secondary Outcomes

Disease free survival

3 year disease free survival rate

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.

Local recurrence free survival

3 year local recurrence free survival rate

Time frame: From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.

Overall survival

3 year overall survival rate

Time frame: From date of randomization until the date of death from any cause, assessed up to 36 months.

Adverse effects

Chemoradiation-related or immunotherapy-related adverse events

Time frame: From date of randomization until the date of death from any cause, assessed up to 5 years

Surgical complications

Surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.

Time frame: The surgery was scheduled 7-8 weeks after the end of chemoradiotherapy. And the surgical complications were assessed up to 5 years from the surgery.

Performance Status (Zubrod-ECOG-WHO method), range 0-5. The higher scores mean a worse quality of life.

Central Contacts

zhen zhang, M.D, PH.D

CONTACT

18801735029 zhen_zhang@fudan.edu.cn

Data from ClinicalTrials.gov

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