Short-course Radiotherapy Followed by Fruquintinib Plus Adebrelimab and CAPOX in the Full Course Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Multicenter, Single-arm, Open-label Study

PHASE2RecruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

December 1, 2023

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2027

Conditions
Locally Advanced Rectal Cancer
Interventions
DRUG

Fruquintinib, Adebrelimab, Oxaliplatin, Capecitabine

"Safety run-in phase: Fruquintinib 4mg/d, oral, once daily, continuous treatment for 2 weeks, 1 week off, q3w, 6 cycles; If the number of patients experiencing dose-limiting toxicity (DLT) was ≤1, the study would continue at that dose level. If the number of patients with DLTs was \>1, the dose of fruquintinib was decreased to 3mg/d, qd po, d1-14, q3w, and the dose expansion phase was continued;Adebrelimab 1200mg, d1, IV infusion, q3W, 6 cycles; Capecitabine 1000 mg/m2, twice a day, po, d1-14, followed by 7 days of rest, q3W, 6 cycles; Oxaliplatin 130 mg/m2, d1, q3W, 6 cycles;~Dose expansion phase: Fruquintinib RP2D, qd po, d1-14, q3w, 6 cycles; Adebrelimab 1200mg, d1, IV infusion, q3W, 6 cycles; Capecitabine 1000 mg/m2, twice a day, po, d1-14, followed by 7 days of rest, q3W, 6 cycles; Oxaliplatin 130 mg/m2, d1, q3W, 6 cycles;"

Trial Locations (1)

Unknown

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

All Listed Sponsors
collaborator

Renmin Hospital of Wuhan University

OTHER

lead

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER