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

NCT06304987 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-03-19

No results posted yet for this study

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.

Conditions

  • Locally Advanced Rectal Cancer

Interventions

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • Changhai Hospital

    collaborator OTHER

  • Beijing Friendship Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2026-04-30
Completion
2026-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06304987 on ClinicalTrials.gov