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Preoperative Chemoradiotherapy and Toripalimab in Locally Recurrent Rectal Cancer

NCT06751394 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-12-27

No results posted yet for this study

Summary

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.

Conditions

  • Recurrent Rectal Cancer

Interventions

DRUG

PD-1 antibody (Toripalimab)

PD-1 antibody: (Toripalimab): 240mg q3w

DRUG

Capecitabine

Capecitabine:1000mg/m² d1-14 q3w; Capecitabine:825mg/m² on the day of radiotherapy

DRUG

Oxaliplatin

130 mg/m² q3w

DRUG

Irinotecan

200 mg/m² q3w

RADIATION

Radiation

45-50Gy/25Fx or 30Gy/15Fx

PROCEDURE

surgery

The type of surgery will depend on the site of recurrence and the involvement of adjacent structures, which will be determined by the surgeons.

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2028-12-31
Completion
2028-12-31

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 NCT06751394 on ClinicalTrials.gov