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Hypofractionated Radiotherapy Plus Immunotherapy Versus Conventional Radiotherapy in Locally Recurrent Rectal Cancer
Sponsor: Fudan University
Summary
TORCH-R2 is a prospective, multicenter, randomized, phase II clinical trial. Patients aged 18 years or older with pelvic recurrence rectal cancer without synchronous distant metastases or recent chemo- and/or radiotherapy treatment, Eastern Cooperative Oncology Group performance status of 0-1will be enrolled . Patients will be randomized to receive either hypofractionated radiotherapy (25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation), 18 weeks sintilimab and investigator's choice of first-line chemotherapy +/- target therapy (experimental arm), or conventional radiotherapy (50Gy/25Fx irradiation or 39Gy/30Fx bid reirradiation) and chemotherapy +/- target therapy (control arm). Patiens will be restaged and followed by multidisciplinary team (MDT) for decision: radical surgery, sustained systerm+/- local treatment of non resection. The primary endpoint was progression-free survival. Secondary endpoints were objective response rate (ORR), complete response rate, R0 resection rate, duration of response (DOR), overall survival (OS), and safety and tolerability of the treatment.
Official title: Multicenter, Randomized, Phase II Trial of Neoadjuvant Hypofractionated Radiotherapy Plus Immunotherapy and First-line Therapy Versus Conventional Radiotherapy Plus First-line Therapy in pMMR Locally Recurrent Rectal Cancer (TORCH-R2)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
221
Start Date
2025-03-10
Completion Date
2030-03-10
Last Updated
2025-04-15
Healthy Volunteers
No
Conditions
Interventions
Conventional Radiotherapy
50Gy/25Fx irradiation or 39Gy/30Fx bid reirradiation (previous pelvic radiation)
Capecitabine
1000mg/m2 d1-14 q3w
5-fluorouracil
400 mg/m2 (bolus) and 2400 mg/m2 (continuous infusion for 48hr)
folinic acid
400 mg/m2 q2w
Oxaliplatin
130 mg/m² q3w or 85 mg/m² q2w
Irinotecan
180 mg/m² q2w and 200 mg/m² q3w
Cetuximab
500 mg/m² q2w
Bevacizumab
5 mg/kg q2w or 7.5mg/kg q3w
Hypofractionated radiotherapy
25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (previous pelvic radiation)
PD-1 antibody
200mg IV q3w
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China