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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

February 28, 2030

Study Completion Date

February 28, 2030

Conditions
Locally Advanced Rectal Cancer (LARC)
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."

Trial Locations (1)

Unknown

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

All Listed Sponsors
lead

Guangdong Provincial People's Hospital

OTHER