Phase 2Not yet recruiting
A Prospective, Biomarker-Stratified Phase 2 Study: β-Hydroxybutyrate as a Predictive Biomarker for Short-Course Radiotherapy Followed by Chemotherapy Plus PD-1 Inhibitor Versus Chemotherapy Alone in Locally Advanced Rectal Cancer
- Sponsor
- Tao Zhang (Academic or other)
- Enrolment
- 144 planned
- Conditions
- Rectal Cancer; Radiotherapy; Immunotherapy; Chemotherapy
- Interventions
- Short-course radiotherapy; Capecitabine; Oxaliplatin; TME surgery; PD -1/PD-L1 monoclonal antibody; Watch & Wait strategy
- Ages
- adults, older adults
- Registry
- NCT07847229
Full record on ClinicalTrials.gov
From the registry
This is a prospective, single-arm, biomarker-stratified, multicenter phase 2 clinical trial. All enrolled patients first receive short-course radiotherapy (SCRT), followed by measurement of serum β-hydroxybutyrate (β-HB) levels to calculate the post-radiotherapy elevation rate. Patients are stratified into an β-HB-positive stratum (elevation significantly) and an β-HB-negative stratum (no elevation), then randomized 1:1 within each stratum to receive either perioperative chemotherapy plus PD-1 inhibitor or perioperative chemotherapy alone. The primary endpoint is the complete response (CR) rate, defined as the composite of pathological complete response (pCR) and clinical complete response (cCR). The study aims to evaluate the efficacy and safety of adding PD-1 inhibitor to perioperative chemotherapy in LARC, and to validate post-radiotherapy β-HB elevation as a predictive biomarker for immunotherapy benefit.
Primary outcomes
- complete response (CR) rate
History
Study completion expected
Primary completion expected
Expected to start
Last registry update
Registered