Prospective Single-arm Phase II Clinical Study of Fruquintinib Combined With Toripalimab and SRT in Neoadjuvant Therapy for Locally Advanced Rectal Cancer

West China Hospital1 site in 1 country44 target enrollmentSeptember 1, 2022

ConditionsRectal Cancer

InterventionsFruquintinib Toripalimab Short-course radiotherapy TME

DrugsFruquintinib Toripalimab

Overview

Phase: Phase 2
Intervention: Fruquintinib
Conditions: Rectal Cancer
Sponsor: West China Hospital
Enrollment: 44
Locations: 1
Primary Endpoint: pCR following neoadjuvant chemotherapy
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate the efficacy and safety of combined fruquintinib、toripalimab and SRT in neoadjuvant therapy for locally advanced rectal cancer.

Detailed Description

The aim of this study is to investigate whether combined fruquintinib、toripalimab and SRT can achieve breakthrough efficacy in neoadjuvant therapy for locally advanced rectal cancer, achieving a better pCR rate and better tolerance compared with conventional neoadjuvant therapy for locally advanced rectal cancer.

Registry

clinicaltrials.gov

Start Date

September 1, 2022

End Date

April 1, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

West China Hospital

Responsible Party

Principal Investigator

Yaqin Zhao

Associate Chief Physician

West China Hospital

Eligibility Criteria

Inclusion Criteria

•Rectal adenocarcinoma was confirmed pathologically;
•Baseline clinical staging was T3-4 and/or N+, and rectal enhanced MRI was recommended as staging standard;
•distance from anus ≤12cm;
•No distant metastasis;
•Age 18-70, regardless of gender;
•ECOG(Eastern Cooperative Oncology Group) score ≤1;
•No chemotherapy or other anti-tumor therapy was used before inclusion;
•Major organ functions within 28 days prior to treatment meet the following criteria: A. Blood routine examination criteria (within 14 days without blood transfusion) : Hemoglobin (HB) ≥80g/L, absolute value of neutrophil (ANC) ≥1.5×109/L, absolute value of lymphocytes ≥ the lower limit of normal value, platelet (PLT) ≥80×109/L; B. Biochemical tests should meet the following criteria: Total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; C. Coagulation tests should meet the following standards: International standardized ratio (INR) or prothrombin time (PT) ≤1.5 ULN; Activated partial thrombin time (APTT) ≤1.5 ULN (if the patient is on anticoagulant therapy, as long as PT and APTT are within the expected treatment range); D. Thyroid function: T3 and T4 levels were normal after drug treatment;
•No history of autoimmune diseases or current autoimmune diseases;
•Subjects must give informed consent to the study prior to the study and have voluntarily signed a written informed consent;

Exclusion Criteria

•Patients who have previously received immune checkpoint inhibitors;
•Known allergic reactions to PD-1 monoclonal antibody active ingredients, TKI inhibitor-related ingredients or any excipients;
•Patients with organ bleeding or bleeding tendency, except for rectal primary tumor bleeding (need investigator to assess the risk of bleeding;
•Pregnant or lactating women;
•years or at the same time have a history of other malignant tumors, but cured skin basal cell carcinoma and cervical carcinoma in situ and thyroid;
•Patients with uncontrolled epilepsy, central nervous system disease or mental disorders, the investigator judged that their clinical severity may hinder the signing of informed consent or affect the patient 's compliance with oral drugs;
•Clinically serious (i.e., active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring drug intervention, or a history of myocardial infarction within the last 12 months;
•Subjects requiring systemic treatment with corticosteroids (greater than 10 mg prednisone equivalent daily) or other immunosuppressive agents (including organ transplant recipients) within 2 weeks before the first dose of study drug;
•Participated in other interventional drug clinical trials within 4 weeks before the first dose;
•Major surgery or severe trauma within 4 weeks before the first dose of study drug;

Arms & Interventions

Fruquintinib& Toripalimab& SRT

Induction treatment: Fruquintinib 5mg d1-d14； Toripalimab 240 mg intravenously d1； Consolidation treatment: SRT: 25 Gy in 5 fractions d22-d26； Fruquitinib 5mg d22-d35，43-56,64-77； Toripalimab 240 mg intravenously d22、43、64； Surgery: Surgical resection will be performed according to the principles of TME(total mesorectal excision) 2-4 weeks after the last dose administration of Fruquintinib； Adjuvant chemotherapy: Standard chemotherapy or observation according to the judgement of Principle Investigator and patients' willing.

Intervention: Fruquintinib