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ACTIVE NOT RECRUITING
NCT06933251
PHASE2

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

Sponsor: Guangdong Provincial People's Hospital

View on ClinicalTrials.gov

Summary

This is a single-center, open-label, single-arm clinical study aimed at conducting a preliminary evaluation of the efficacy and safety of combining PCSK9 inhibitors and PD-1 inhibitors (dual inhibitors) with neoadjuvant chemoradiotherapy in patients with pMMR/MSS locally advanced rectal cancer.

Official title: Clinical Study of PCSK9 Inhibitor and PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy in the Treatment of pMMR/MSS Locally Advanced Rectal Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-01-20

Completion Date

2030-02-28

Last Updated

2026-03-09

Healthy Volunteers

No

Interventions

DRUG

Neoadjuvant Chemoradiotherapy Combined with PD-1 inhibitor Immunotherapy and PCSK9 Inhibitor Therapy

1. Neoadjuvant Treatment 1.1 Short-Course Radiotherapy (SCRT) Total Dose: 25 Gy in 5 fractions over 5 days. Interval: 1-week rest before the next stage. 1.2 Chemotherapy and Immunotherapy Regimen: Start 1 week after SCRT with 6 cycles of CAPOX chemotherapy combined with PD-1 inhibitor immunotherapy (3 weeks per cycle). 1.3 PCSK9 Inhibitor Administration: Subcutaneous injection every 4 weeks during neoadjuvant therapy (6 cycles total). 2. Multidisciplinary Team (MDT) Discussion Timing: 2 weeks after completing neoadjuvant therapy. Approach: Patients achieving clinical complete response (cCR): "Watch-and-wait" strategy. Others: Surgery based on MDT evaluation.

Locations (2)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

No. 106, Zhongshan 2nd Road, Yuexiu District, Guangzhou

Guangzhou, Guangdong, China