Hypofractionated Radiotherapy Plus Immunotherapy Versus Conventional Radiotherapy in Locally Recurrent Rectal Cancer
NCT ID: NCT06928584
Last Updated: 2025-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
221 participants
INTERVENTIONAL
2025-03-10
2030-03-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional radiotherapy arm
Conventional radiotherapy (50Gy/25Fx irradiation or 39Gy/30Fx bid reirradiation) and investigator's choice of first-line chemotherapy +/- target therapy.
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 plus Immunotherapy arm
Hypofractionated radiotherapy (25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation), 18 weeks sintilimab and investigator's choice of first-line chemotherapy +/- target therapy.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
TBIL \> 1.5 ULN, or TBIL \> 2.5 ULN in patients with liver metastasis. AST or ALT \> 2.5 ULN, or ALT and/or AST \> 5 ULN in patients with liver metastasis.
Cr \> 1.5 ULN, or creatinine clearance\< 50 mL/min (calculated according to Cockcroft Gault formula).
APTT \> 1.5 ULN, PT \> 1.5 ULN (subject to the normal value of the clinical trial research center).
Serious electrolyte abnormalities. Urinary protein ≥ 2+, or 24-h urine protein ≥1.0 g/24 h. Uncontrolled hypertension: SBP \>140 mmHg or DBP \> 90 mmHg. A history of arterial thrombosis or deep vein thrombosis within 6 months; a history of bleeding or evidence of bleeding tendency within 2 months.
A history of heart disease within 6 months. Uncontrolled malignant pleural effusion, ascites, or pericardial effusion. History of checkpoint inhibitor therapy. The presence of a clinically detectable second primary malignancy, or history of other malignancies within 5 years.
A history of liver disease including, but not limited to, HBV infection or HBV DNA positive (≥1×104/mL), HCV infection or HCV DNA positive (≥1×103/mL), and liver cirrhosis.
Pregnant or lactating women or women who may be pregnant have a positive pregnancy test before the first medication, or the female participants themselves and their partners who were unwilling to implement strict contraception during the study period.
The investigator considers that the subject is not suitable to participate in this clinical study due to any clinical or laboratory abnormalities or compliance problems.
Serious mental abnormalities. The diameter of brain metastasis is greater than 3 cm or the total volume is greater than 30 cc. Clinical or radiological evidence of spinal cord compression, or tumors within 3 mm of the spinal cord on MRI.
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhen Zhang
Professor
Principal Investigators
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Zhen Zhang, MD PhD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FDRT-2024-416-3970
Identifier Type: -
Identifier Source: org_study_id
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