Total Neoadjuvant Treatment ±Immunotherapy for High Risk Locally Advanced Rectal Cancer (TNTi)

Peking University Cancer Hospital & Institute1 site in 1 country472 target enrollmentMarch 29, 2023

ConditionsRectal Cancer

InterventionsCamrelizumab ＋Immunotherapy

DrugsCamrelizumab ＋Immunotherapy

Overview

Phase: Phase 3
Intervention: Camrelizumab ＋Immunotherapy
Conditions: Rectal Cancer
Sponsor: Peking University Cancer Hospital & Institute
Enrollment: 472
Locations: 1
Primary Endpoint: The PCR rate between total neoadjuvant treatment ±immunotherapy
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to compare the PCR rate between Total Neoadjuvant Treatment ±Immunotherapy in high risk locally advanced rectal cancer. The main questions it aims to answer are:

The PCR rate between the two groups
The 3years DFS between the two groups
Chemoradiotherapy and immunotherapy toxicity
Postoperative complications Participants will receive total neoadjuvant treatment ±immunotherapy followed by surgery.

Researchers will compare neoadjuvant treatment ±immunotherapy to see the PCR rate.

Registry

clinicaltrials.gov

Start Date

March 29, 2023

End Date

October 1, 2029

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Peking University Cancer Hospital & Institute

Responsible Party

Principal Investigator

Aiwen Wu

Chief of Gastrointestinal Center Unit III

Peking University Cancer Hospital & Institute

Eligibility Criteria

Inclusion Criteria

•\>18，\<75 years old
•ECOG score 0-1
•colorectal adenocarcinoma confirmed by pathology
•The distance between the lower margin of the tumor and the anal margin is ≤12cm or the distance between the anorectal ring (ARJ) is ≤8cm
•The initial local MRI stage was T4b, or mrN2, or positive MRF, or positive EMVI, or lateral lymph node metastasis (mrLLND+)
•No evidence of distant metastasis
•No history of pelvic radiotherapy
•No history of rectal cancer surgery or chemotherapy
•Systemic infections that do not require antibiotic treatment
•Not associated with immune system diseases

Exclusion Criteria

•Recurrent rectal cancer
•Microsatellite instability (MSI) or mismatch repair gene deletion (dMMR)
•The patient has had other malignancies in the past 5 years (in addition to properly treated basal cell carcinoma and skin squamous cell carcinoma)
•The patient has had arterial embolic diseases in the past 6 months, such as angina pectoris, MI, TIA, CVA, etc.
•Have received other types of anti-tumor or experimental therapy
•The patient is a pregnant or lactating woman
•The patient has other diseases or mental disorders that may affect the patient's participation in this study
•Patients who have previously received anti-PD-1, anti-PD-L1, anti-PD-L2 therapy or VEGFR TKI therapy.
•Major surgical procedures were performed/received within 4 weeks prior to the first administration of the study drug or the side effects of which have not yet recovered, live vaccination, immunotherapy, and radiotherapy within 2 weeks.
•Study patients who had received hematopoietic stimulating factors, such as granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc., within 1 week before the first administration of the drug.