QL1706 With Short-Course Radiotherapy and Chemotherapy for MSS Rectal Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

September 20, 2025

Primary Completion Date

September 20, 2026

Study Completion Date

September 20, 2029

Conditions
Locally Advanced Rectal Cancer (LARC)Mismatch Repair-Proficient (pMMR) Rectal CancerNon-metastatic Rectal Cancer
Interventions
DRUG

Drug: QL1706 Drug: mFOLFOX6 Radiation: Short-Course Radiotherapy (SCRT)

"QL1706 is an investigational bifunctional MabPair antibody that simultaneously targets PD-1 (IgG4) and CTLA-4 (IgG1). It is administered intravenously according to the study protocol during the neoadjuvant chemotherapy cycles. The use of QL1706 aims to enhance antitumor immunity in the pMMR/MSS rectal cancer setting, a population typically unresponsive to immune checkpoint blockade alone.~mFOLFOX6 is a standard oxaliplatin-based chemotherapy regimen composed of oxaliplatin, leucovorin, and 5-fluorouracil. It is administered in combination with QL1706 during the neoadjuvant phase as part of total neoadjuvant therapy (TNT). The regimen is modified to optimize tolerability while maintaining efficacy in locally advanced rectal cancer.~Short-course radiotherapy consists of a total dose of 25 Gy delivered in 5 fractions over one week to the pelvis. This approach is designed to rapidly downstage tumors, release tumor antigens, and prime the immune microenvironment for subsequent immunotherapy"

All Listed Sponsors
lead

Sun Yat-sen University

OTHER