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Retlirafusp Alfa Plus Targeted Therapy and Chemotherapy for Unresectable Colorectal Liver-Limited Metastases
Sponsor: Peking University Cancer Hospital & Institute
Summary
This is a single-center, open-label, exploratory phase II trial to evaluate efficacy and safety of Retlirafusp alfa (PD-L1/TGF-βRII bispecific fusion protein) combined with standard first-line targeted-chemotherapy as conversion therapy in adult patients with initially unresectable microsatellite-stable (MSS/pMMR) colorectal adenocarcinoma liver metastases. Two pre-defined cohorts are enrolled: Cohort 1 for RAS/BRAF wild-type left-sided primary tumor (mFOLFOX6 + cetuximab + Retlirafusp alfa); Cohort 2 for RAS/BRAF-mutant or right-sided primary tumor (CAPEOX + bevacizumab + Retlirafusp alfa).
Official title: Retlirafusp Alfa Plus Targeted Therapy and Chemotherapy as Conversion Therapy for Initially Unresectable Colorectal Cancer Liver Metastases: An Exploratory Phase II Study
Key Details
Gender
All
Age Range
18 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-09-30
Completion Date
2029-12-30
Last Updated
2026-09-11
Healthy Volunteers
No
Interventions
Retlirafusp alfa Combined with Targeted Therapy and Chemotherapy
Cohort 1 (RAS/BRAF wild-type, left-sided primary colon cancer): * Retlirafusp alfa 1800 mg IV D1 every 3 weeks * Cetuximab 500 mg/m² IV D1 every 2 weeks * mFOLFOX6: Oxaliplatin 85 mg/m² IV D1 q2w; Leucovorin 400 mg/m² IV D1 q2w; 5-FU 400 mg/m² IV bolus D1 q2w plus 2400 mg/m² 48-h continuous infusion q2w. Cohort 2 (RAS/BRAF mutant OR RAS/BRAF wild-type right-sided primary colon cancer): * Retlirafusp alfa 1800 mg IV D1 every 3 weeks * Bevacizumab 7.5 mg/kg IV D1 every 3 weeks * CAPEOX: Oxaliplatin 130 mg/m² IV D1 q3w; Capecitabine 1000 mg/m² orally twice daily D1-14 q3w.
Locations (1)
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China