Actively Recruiting
Hypofractionated Radiotherapy Plus Immunotherapy Versus Conventional Radiotherapy in Locally Recurrent Rectal Cancer
Led by Fudan University · Updated on 2025-04-15
221
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hypofractionated Radiotherapy Plus Immunotherapy Versus Conventional Radiotherapy in Locally Recurrent Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Eastern Cooperative Oncology Group performance status of 0-1
- Pelvic recurrence of rectal cancer confirmed by MRI or enhanced CT
- No synchronous distant metastases
- No prior radiotherapy within the last 6 months
- No prior first-line chemotherapy
- Life expectancy of at least 24 weeks as determined by investigator
- Adequate organ function
- Not pregnant or lactating
- Able and willing to provide written informed consent
You will not qualify if you...
- Low neutrophil count below 1.5 x 10^9/L
- Low platelet count below 100 x 10^9/L (or below 80 x 10^9/L if liver metastases present)
- Low hemoglobin below 90 g/L
- Elevated total bilirubin over 1.5 times upper limit of normal (ULN), or over 2.5 times ULN with liver metastases
- Elevated AST or ALT over 2.5 times ULN, or over 5 times ULN with liver metastases
- Creatinine above 1.5 times ULN or creatinine clearance below 50 mL/min
- Prolonged clotting times (APTT or PT over 1.5 times ULN)
- Serious electrolyte imbalances
- Significant protein in urine (urinary protein ≥ 2+ or 24-hour urine protein ≥ 1.0 g)
- Uncontrolled high blood pressure (systolic >140 mmHg or diastolic >90 mmHg)
- History of arterial or deep vein thrombosis within 6 months
- History or evidence of bleeding within 2 months
- History of heart disease within 6 months
- Uncontrolled malignant pleural effusion, ascites, or pericardial effusion
- Previous treatment with checkpoint inhibitor therapy
- Presence of another primary cancer or history of other cancers within 5 years
- Liver disease including HBV or HCV infection or cirrhosis
- Pregnant or lactating women, or women not willing to use strict contraception
- Investigator judgment of unsuitability due to clinical or laboratory abnormalities or compliance issues
- Serious mental disorders
- Brain metastases larger than 3 cm or total volume over 30 cc
- Evidence of spinal cord compression or tumors within 3 mm of spinal cord on MRI
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
Zhen Zhang, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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