Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07815288
PHASE2

Retlirafusp Alfa Plus Targeted Therapy and Chemotherapy for Unresectable Colorectal Liver-Limited Metastases

Sponsor: Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

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

DRUG

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