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

Lin Chen

Status and phase: Enrolling; Phase 2

Conditions: Locally Advanced Gastric Carcinoma; Efficacy; HER2 Negative; Safety

Treatments: Drug: Tirolizumab+SOX/XELOX; Drug: SOX/XELOX

Study type: Interventional

Funder types: Other

Identifiers

NCT06284746

301Qiaoz

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups

Tirelizumab combined with neoadjuvant chemotherapy

Experimental group

Description:

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.

Treatment:

Drug: Tirolizumab+SOX/XELOX

standard chemotherapy

Active Comparator group

Description:

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

Treatment:

Drug: SOX/XELOX