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

NCT ID: NCT06284746

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-07-30

Brief 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.

Conditions

Locally Advanced Gastric Carcinoma; HER2 Negative; Efficacy; Safety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Tirolizumab+SOX/XELOX

Intervention Type: DRUG

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.

standard chemotherapy

Four cycles of standard chemotherapy regimen (SOX/XELOX regimen) were administered before and after surgery.

Group Type: ACTIVE_COMPARATOR

SOX/XELOX

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lin Chen

OTHER

Sponsor Role: lead

Responsible Party

Lin Chen

Attending physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

General Surgery Institute, China PLA General Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yunhe Gao, Ph.D.

Role: primary

gaoyunhe@301hospital.org

86-010-66937164

References

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Reference Type: BACKGROUND

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Reference Type: RESULT

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Other Identifiers

301Qiaoz

Identifier Type: -

Identifier Source: org_study_id