Status:
UNKNOWN
The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSI-H Locally Advanced Rectal Cancer
Lead Sponsor:
Fudan University
Conditions:
Locally Advanced Rectal Cancer
Eligibility:
All Genders
15-70 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- pathological confirmed adenocarcinoma
- clinical stage T3-4 and/or N+
- the distance from anal verge less than 12 cm
- without distance metastases
- age 18-70 years old, female and male
- KPS \>=70
- UGT1A1\*28 6/6 or 6/7
- the MSI status is MSI-H or d-MMR
- without previous anti-cancer therapy or immunotherapy
- with good compliance
- signed the inform consent
Exclusion
- pregnancy or breast-feeding women
- history of other malignancies within 5 years
- serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
- immunodeficiency disease or long-term using of immunosuppressive agents
- 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
- DPD deficiency
- UGT1A1\*28 7/7
- the MSI status is MSS or p-MMR
- allergic to any component of the therapy
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04411524
Start Date
July 1 2020
End Date
December 31 2022
Last Update
June 2 2020
Active Locations (1)
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1
Zhen Zhang
Shanghai, Shanghai Municipality, China, 200032