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Trial Title:
Tirelizumab Combined With Chemotherapy in the Treatment of HER-2 Negative Locally Advanced Gastric Cancer
NCT ID:
NCT06284746
Condition:
Locally Advanced Gastric Carcinoma
HER2 Negative
Efficacy
Safety
Conditions: Official terms:
Stomach Neoplasms
Fluorouracil
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Tirolizumab+SOX/XELOX
Description:
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.
Arm group label:
Tirelizumab combined with neoadjuvant chemotherapy
Intervention type:
Drug
Intervention name:
SOX/XELOX
Description:
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.
Arm group label:
standard chemotherapy
Summary:
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
General Surgery Institute, China PLA General Hospital
Address:
City:
Beijing
Zip:
100853
Country:
China
Status:
Recruiting
Contact:
Last name:
Yunhe Gao, Ph.D.
Phone:
86-010-66937164
Email:
gaoyunhe@301hospital.org
Start date:
October 1, 2023
Completion date:
July 30, 2025
Lead sponsor:
Agency:
Lin Chen
Agency class:
Other
Source:
Chinese PLA General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06284746
