Preoperative Chemoradiotherapy and Toripalimab in Locally Recurrent Rectal Cancer

Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Study ID
NCT06751394
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Recurrent Rectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • PD-1 antibody (Toripalimab) — DRUG
    PD-1 antibody: (Toripalimab): 240mg q3w
  • Capecitabine — DRUG
    Capecitabine:1000mg/m² d1-14 q3w; Capecitabine:825mg/m² on the day of radiotherapy
  • Oxaliplatin — DRUG
    130 mg/m² q3w
  • Irinotecan — DRUG
    200 mg/m² q3w
  • Radiation — RADIATION
    45-50Gy/25Fx or 30Gy/15Fx
  • surgery — PROCEDURE
    The type of surgery will depend on the site of recurrence and the involvement of adjacent structures, which will be determined by the surgeons.

Study Details

The study is a prospective, single-center, single-arm, phase II clinical trial. Patients with pelvic recurrent rectal cancer aged from 18 to 75 years, Eastern Cooperative Oncology Group performance status of 0-1, will receive 45-50Gy/25Fx irradiation or 30Gy/15Fx reirradiation (history of pelvic radiation). PD-1 inhibitor (Toripalimab) was used throughout the course of induction chemotherapy (before radiation), concurrent chemoradiation and consolidation chemotherapy (after radiation); radical resection was followed by well-experienced surgeons . The primary endpoint was pathological complete response (pCR) rate. Secondary endpoints were R0 resection rate, 3-year progression-free survival, overall survival, pathological tumor regression grade, operation characteristics and incidence of major surgical complications.

Key Dates

Start date
Jan 1, 2025
Status verified
Dec 2024
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: Group A
    The patients will receive 2 cycles of XELOX or XELIRI and PD-1 antibody, followed by long course radiotherapy (45-50Gy/25f or 30Gy/25f), concurrent with Capecitabine and 1-2 cycles of PD-1 antibody, then receive 2-3 cycles of XELOX or XELIRI and PD-1 antibody. Curative surgery is scheduled after neoadjuvant treatment.

Primary Outcome Measure

Pathological complete response rate [ Time Frame: up to 1 year ]

Central Contacts