Clinical trial NCT06284746: Tirelizumab Combined With Chemotherapy in the Treatment of HER-2 Negative Locally Advanced Gastric Cancer
Official title: Clinical Efficacy and Safety of Tirelizumab Combined With Chemotherapy in the Treatment of HER-2 Negative Locally Advanced Resectable Gastric Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Locally Advanced Gastric Carcinoma
HER2 Negative
Efficacy
Safety
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pathological complete response (pCR)
timeFrame: Less than 20 months
measure: Objective Response Rate（ORR）
timeFrame: Less than 20 months
Secondary outcomes:
measure: Disease-free survival（DFS）
timeFrame: Less than 20 months
measure: Overall survival（OS）
timeFrame: Less than 20 months
measure: Major Pathologic Response（MPR）
timeFrame: Less than 20 months
measure: The incidence of adverse events during treatment
timeFrame: Less than 20 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: General Surgery Institute, China PLA General Hospital
state: Beijing
Study officials:
References:
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