Tirelizumab Combined With Chemotherapy in the Treatment of HER-2 Negative Locally Advanced Gastric Cancer

February 28, 2024 updated by: Lin Chen

Clinical Efficacy and Safety of Tirelizumab Combined With Chemotherapy in the Treatment of HER-2 Negative Locally Advanced Resectable Gastric Cancer

This study objectively analyzes the safety and survival evaluation of perioperative immunotherapy combined with chemotherapy in locally advanced gastric cancer patients through a prospective randomized controlled trial research method; By comparing the pathological response rate, disease-free survival rate, and incidence of adverse events between the combination therapy and chemotherapy alone group, we aim to verify the efficacy and safety of tirelizumab combined with SOX/XELOX chemotherapy in disease control of locally advanced gastric cancer patients, laying the foundation and providing a basis for large-scale multicenter clinical research.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • General Surgery Institute, China PLA General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The subjects voluntarily joined this study and signed an informed consent form
  • Locally advanced gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or histology as HER-2 negative (cT2-4N+M0 Phase II-III)
  • The primary lesion can be surgically removed, and the patient is willing to receive surgical treatment
  • There are measurable solid tumors (efficacy evaluation standard: RECIST 1.1)
  • Tumor evaluation should be conducted through CT scanning or MRI within 28 days before treatment
  • ECOG score 0-1
  • Life expectancy ≥ 12 months.

Exclusion Criteria:

  • Preoperative imaging examination indicates distant or peritoneal metastasis in patients
  • Subjects with any known active autoimmune disease
  • Serious cardiovascular disease
  • The serum of the subjects tested positive for HIV
  • Active hepatitis B (HbsAg positive and HBV-DNA ≥ 10 ^ 3copies/mL) or active hepatitis C (HCV antibody positive and HCV-DNA positive, requiring antiviral treatment at the same time)
  • Known subjects with previous allergies to macromolecular protein formulations/monoclonal antibody components, or other contraindications to immunotherapy or chemotherapy
  • Have a history of alcohol, drug, or substance abuse
  • Individuals with a clear history of neurological or mental disorders, such as epilepsy, dementia, and poor compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tirelizumab combined with neoadjuvant chemotherapy
Four cycles of tirolizumab combined with SOX/XELOX neoadjuvant chemotherapy regimen before surgery, followed by laparoscopic D2 gastric cancer radical surgery, and four cycles of adjuvant chemotherapy after surgery.
Drug: Tirolizumab+SOX/XELOX
Tirolizumab combined with chemotherapy(SOX/XELOX) regimen. The SOX regimen consists of the drugs Tegilol (S-1) and Oxaliplatin. The XELOX regimen consists of the drugs oxaliplatin and capecitabine.
Active Comparator: standard chemotherapy
Four cycles of standard chemotherapy regimen (SOX/XELOX regimen) were administered before and after surgery.
Drug: SOX/XELOX
Simple chemotherapy regimen (SOX/XELOX regimen). The SOX regimen consists of the drugs Tegilol (S-1) and Oxaliplatin. The XELOX regimen consists of the drugs oxaliplatin and capecitabine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete response (pCR)
Time Frame: Less than 20 months
After neoadjuvant therapy, there were no residual surviving tumor cells in the tumor bed during the pathological remission assessment of postoperative specimens.
Less than 20 months
Objective Response Rate（ORR）
Time Frame: Less than 20 months
The proportion of patients whose tumor volume has shrunk to a predetermined value and can maintain the minimum time limit requirement is the sum of complete response (CR) and partial response (PR) ratios, with ORR=CR+PR.
Less than 20 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival（DFS）
Time Frame: Less than 20 months
Time from randomization to disease recurrence or (for any reason) death.
Less than 20 months
Overall survival（OS）
Time Frame: Less than 20 months
Time from randomization to death (for any reason)
Less than 20 months
Major Pathologic Response（MPR）
Time Frame: Less than 20 months
After preoperative treatment, the number of surviving tumors decreases below the threshold that can affect clinical prognosis.
Less than 20 months
The incidence of adverse events during treatment
Time Frame: Less than 20 months
Including adverse reactions related to immunotherapy and postoperative complications. Reflecting safety and tolerability.
Less than 20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lin Chen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

July 30, 2025

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Estimated)

February 29, 2024

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 301Qiaoz

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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