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

Sponsor
Fudan University
Study ID
NCT04411537
Phase
PHASE2
Status
Unknown

Conditions

  • Locally Advanced Rectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • PD-1 antibody — DRUG
    Before neo-CRT: 2 cycles of PD-1 antibody, 240mg d1 q2w. After neo-CRT: 3 cycles of PD-1 antibody, 240mg d1 q2w.
  • Capecitabine — DRUG
    During neo-CRT: 625mg/m2 bid Monday-Friday per week
  • Irinotecan — DRUG
    During neo-CRT: 80mg/m2 qw (UGT1A1\*28 6/6) or 65mg/m2 qw (UGT1A1\*28 6/7)
  • Neoadjuvant Radiotherapy — RADIATION
    IMRT DT: 50Gy/25Fx

Study Details

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.

Key Dates

Start date
Jul 1, 2020
Status verified
May 2020
Primary completion
Apr 30, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    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.

Primary Outcome Measure

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 ]

Central Contacts

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