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

NCT04411524 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-06-02

No results posted yet for this study

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.

Conditions

  • Locally Advanced Rectal Cancer

Interventions

DRUG

PD-1 antibody

Before neo-CRT: 2 cycles of PD-1 antibody After neo-CRT: 3 cycles of PD-1 antibody

DRUG

Capecitabine

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

DRUG

Irinotecan

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

RADIATION

Neoadjuvant Radiotherapy

IMRT DT: 50Gy/25Fx

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Zhen Zhang, M.D, PH.D · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-04-30
Completion
2022-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04411524 on ClinicalTrials.gov