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

Beijing Friendship Hospital2 sites in 1 country50 target enrollmentApril 2024

ConditionsLocally Advanced Rectal Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Locally Advanced Rectal Cancer
Sponsor: Beijing Friendship Hospital
Enrollment: 50
Locations: 2
Primary Endpoint: CR
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 2024

End Date

May 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Beijing Friendship Hospital

Responsible Party

Principal Investigator

Zhongtao Zhang

professor

Beijing Friendship Hospital

Eligibility Criteria

Inclusion Criteria

•Sign a written informed consent form and voluntarily join this study;
•Age 18-75 years old, male or female;
•Pathologically confirmed adenocarcinoma of the rectum;
•Clinically staged as II\~III stage by MRI (according to the 8th edition of AJCC);
•Tumor lower edge distance from the anal margin ≤10cm;
•Able to undergo surgical resection;
•Able to swallow pills normally;
•ECOG PS 0-1;
•No prior anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc.;
•Planning to undergo surgical treatment after completing neoadjuvant therapy;

Exclusion Criteria

•History of allergy to monoclonal antibodies, PD-1 monoclonal antibodies, capecitabine, or oxaliplatin;
•History of receiving or currently receiving any of the following treatments:
•Any surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc., for tumors;
•Use of immunosuppressive drugs or systemic steroid therapy to achieve immunosuppression (dose \>10mg/day prednisone or equivalent) within 2 weeks before the first use of the study drug; inhalation or local use of steroids and adrenal cortical hormone replacement therapy with a dose \>10mg/day prednisone or equivalent is allowed in the absence of active autoimmune diseases;
•Receipt of attenuated live vaccines within 4 weeks before the first use of the study drug;
•Underwent major surgery or had severe trauma within 4 weeks before the first use of the study drug;
•Active autoimmune diseases or history of autoimmune diseases, including but not limited to: interstitial pneumonia, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered for inclusion after hormone replacement therapy); psoriasis or childhood asthma/allergies that have completely resolved and do not require any intervention in adulthood may be considered for inclusion, but patients requiring bronchodilators for medical intervention are not eligible for inclusion;
•History of immunodeficiency, including HIV positive, or acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation;
•Presence of poorly controlled clinical symptoms or diseases of the heart, including but not limited to: (1) NYHA class II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within the past year, (4) clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or poorly controlled after clinical intervention;
•Severe infection (CTCAE \> grade 2) within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, septicemia, complications of infection, etc.; baseline chest imaging suggests active pulmonary inflammation, presence of symptoms and signs of infection within 14 days before the first use of the study drug or requiring oral or intravenous antibiotic therapy, except for prophylactic use of antibiotics;