The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer

Summary

The study is a prospective, single-center, single-arm, two-cohort, phase II clinical trial. Patients aged 18 years or older who had pelvic recurrence rectal cancer with or without resectable distant metastasis, with treatment naive disease (cohort A) or progressive disease after first-line chemotherapy (cohort B), Eastern Cooperative Oncology Group performance status of 0-1, will receive 25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (pelvic radiation history), 18 weeks toripalimab and investigator's choice of chemotherapy +/- target therapy, and stereotactic ablative radiotherapy (SABR) for all metastatic lesions between chemoimmunotherapy cycles, followed by multidisciplinary team (MDT) for decision:follow-up of complete response (CR), radical surgery, sustained treatment of non resection, or exit.

The primary endpoint was local objective response rate. Secondary endpoints were extrapelvic objective response rate, R0 resection rate, duration of response, progression-free survival, overall survival, and safety and tolerability of the treatment.

Shanghai Junshi Biomedical Technology Co., Ltd. Provides the first three cycles of toripalimab for free and has purchased liability insurance for clinical trial subjects.

Conditions

• Recurrent Rectal Cancer

Interventions

DRUG

PD-1 antibody

PD-1 antibody (Toripalimab): 240mg q3w or 160mg q2w

DRUG

Capecitabine

Capecitabine: 1000mg/m2 d1-14 q3w

DRUG

5FU

400 mg/m2 (bolus) and 2400 mg/m2 (continuous infusion for 48hr)

DRUG

folinic acid

400 mg/m2 q2w

DRUG

Oxaliplatin

130 mg/m² q3w or 85 mg/m² q2w

DRUG

Irinotecan

180 mg/m² q2w and 200 mg/m² q3w

DRUG

Raltitrexed

2 mg/m² q2w and 3 mg/m² q3w

DRUG

Cetuximab

400 mg/m² q2w

DRUG

Bevacizumab

5 mg/kg q2w or 7.5mg/kg q3w

RADIATION

Radiation

25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (pelvic radiation history) for pelvic recurrence tumor. 35-60Gy/5-8Fx irradiation for distance metastasis tumor.

Sponsors & Collaborators

• Fudan University

  lead OTHER

Principal Investigators

• Zhen Zhang, MD PhD · Fudan University

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

2022-11-30

Primary Completion

2024-12-01

Completion

2025-12-01

Countries

• China

Study Locations