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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
221
50Gy/25Fx irradiation or 39Gy/30Fx bid reirradiation (previous pelvic radiation)
1000mg/m2 d1-14 q3w
400 mg/m2 (bolus) and 2400 mg/m2 (continuous infusion for 48hr)
400 mg/m2 q2w
130 mg/m² q3w or 85 mg/m² q2w
180 mg/m² q2w and 200 mg/m² q3w
500 mg/m² q2w
5 mg/kg q2w or 7.5mg/kg q3w
25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (previous pelvic radiation)
200mg IV q3w
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGProgression-Free Survival
time from the date of start treatment until disease progression or censored at last follow-up or death.
Time frame: up to 3 years
Objective response rate (ORR)
the proportion of patients with the best response of confirmed complete or partial response according to RECIST 1.1, as assessed by the investigator.
Time frame: up to 1 year
Complete response rate
the proportion of patients with the best response of confirmed complete response according to RECIST 1.1, as assessed by the investigator.
Time frame: up to 1 year
R0 resection rate
the proportion of patients who achieve R0 resection of pelvic recurrent tumour after therapy.
Time frame: up to 1 year
Duration of response (DOR)
time from the first documented pelvic objective response to pelvic or extrapelvic disease progression in patients with confirmed response.
Time frame: up to 3 years
Overall Survival
from the date of start treatment until the date of death from any cause or censored at last follow-up.
Time frame: up to 3 years
Safety and tolerability
proportion of patients with treatment-related acute toxicities as assessed by NCI CTCAE v5.0, from treatment initiation until 90 days upon completion of immunotherapy.
Time frame: up to 1 year
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