Neoadjuvant Short-Course Radiotherapy With or Without Chemotherapy and AK112 in Locally Advanced Rectal Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

February 10, 2025

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2027

Conditions
Rectal Cancer
Interventions
DRUG

AK112 with SCRT and CapeOX

In the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7day interval, patients will receive 2 cycles of CapeOX chemotherapy combined with AK112 (every 3 weeks; Day 1: Oxaliplatin, 130 mg/m², IV infusion; Day 1: AK112, 20 mg/kg, IV infusion; Day 1 to Day 14: Capecitabine, 850-1000 mg/m², BID, orally).

DRUG

AK112 with SCRT

In the 1st week, neoadjuvant short-course radiotherapy will be administered (25 Gy in 5 fractions over 5 days). After a 7-day interval, patients will receive 2 cycles of AK112 treatment (Day 1: AK112, 20 mg/kg, IV infusion).

Trial Locations (1)

400000

RECRUITING

Daping Hospital, Chongqing

All Listed Sponsors
lead

fan li

OTHER