NCT06304987

Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and PCSK9 Inhibitor for pMMR/MSS Locally Advanced Mid-low Rectal Cancer

The Efficacy and Safety of Preoperative Neoadjuvant Chemoradiation Combined With PD-1 Inhibitor and PCSK9 Inhibitor in the Treatment of pMMR/MSS Locally Advanced Middle and Low Rectal Cancer: a Multicenter Study, Prospective, Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, prospective, randomized controlled study to evaluate the effectiveness and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and PCSK9 inhibitor in the treatment of patients with pMMR/MSS locally advanced middle and low rectal cancer.

Detailed description

This study included patients with locally advanced low rectal cancer as research subjects, and evaluated the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor (Sintilimab) and PCSK9 inhibitor (Tafolecimab) or neoadjuvant chemoradiotherapy combined with PD -1 (Sintilimab) for patients with locally advanced rectal cancer. The primary endpoints of the study are clinical complete response (cCR) (including imaging and endoscopic complete response) and pathological complete response (pCR). Secondary endpoints are major pathological response rate (MPR), objective response rate (ORR), disease-free survival (DFS), overall survival (OS), organ preservation rate (OPR), and neoadjuvant rectal (NAR) score, quality of life score (QoL), safety and tolerability.

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Long-course chemoradiation and PD-1 inhibitor, with PCSK9 inhibitor	In long-course chemoradiotherapy (CRT) + PD-1 inhibitor for LARC patients, the experimental group used concurrent PCSK9 inhibitor, and the active comparison group did not use PCSK9 inhibitor.
COMBINATION_PRODUCT	Long-course chemoradiation and PD-1 inhibitor, without PCSK9 inhibitor	In long-course chemoradiotherapy (CRT) + PD-1 inhibitor for LARC patients, the experimental group used concurrent PCSK9 inhibitor, and the active comparison group did not use PCSK9 inhibitor.

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2024-03-12
• Last updated: 2024-03-19

Locations

2 sites across 1 country: China