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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
General Surgery Institute, China PLA General Hospital
RECRUITING
Beijing
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2025-07-30
Participants
Target number of participants: 80
Treatments
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.
Active_comparator: standard chemotherapy
Four cycles of standard chemotherapy regimen (SOX/XELOX regimen) were administered before and after surgery.
Related Therapeutic Areas
Sponsors
Leads: Lin Chen

This content was sourced from clinicaltrials.gov

Similar Clinical Trials