A Single-centre Phase II Clinical Study of Tislelizumab Combined with SOX Regimen in the Treatment of Locally Advanced Gastric Cancer/gastroesophageal Junction Adenocarcinoma

Liaoning Cancer Hospital & Institute0 sites20 target enrollmentDecember 30, 2024

ConditionsGastric/Gastroesophageal Junction Adenocarcinoma

InterventionsTislelizumab + SOX

DrugsTislelizumab + SOX

Overview

Phase: Phase 2
Intervention: Tislelizumab + SOX
Conditions: Gastric/Gastroesophageal Junction Adenocarcinoma
Sponsor: Liaoning Cancer Hospital & Institute
Enrollment: 20
Primary Endpoint: Pathologic complete response rate (pCR)
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study is to evaluate the efficacy of neoadjuvant long-term treatment with tislelizumab in combination with SOX in the treatment of locally advanced gastric/gastroesophageal junction adenocarcinoma.

Registry

clinicaltrials.gov

Start Date

December 30, 2024

End Date

March 31, 2028

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Liaoning Cancer Hospital & Institute

Responsible Party

Principal Investigator

Zheng Zhichao

Offices Director

Liaoning Cancer Hospital & Institute

Eligibility Criteria

Inclusion Criteria

•Willing to participate in this study, able to sign the informed consent form, and with compliance;
•No gender restriction, aged ≥18 and ≤70 years (at the time of signing the informed consent form);
•ECO score of 0-1;
•Estimated survival ≥6 months;
•HER-2 negative;
•Central laboratory confirmed PD-L1 expression in the, with a combined positive score (CPS) ≥1;
•Histological and radiological assessment confirmed as advanced gastric cancer (GC) or gastroesal junction (GEJ) adenocarcinoma, with a clinical stage of cT3-T4aN M0;
•Pre-enrollment by the attending physician to determine eligibility for R0 resection with curative intent;
•Good cardiac function. Patients with underlying ischemic, valvular disease, or other severe heart disease should have a preoperative assessment by a cardiologist if there are clinical indications;
•No prior cytotoxic or targeted, no prior partial or complete esophagogastric tumor resection;

Exclusion Criteria

•Have had or simultaneously have other active malignant tumors within 5 years. Cured localized tumors, as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast in situ, are eligible;
•Patients who are preparing for or have previously undergone organ or bone marrow transplantation;
•Have ≥2 grade myocardial ischem or myocardial infarction, arrhythmia (QTc ≥470ms), and ≥2 grade congestive heart failure (New York Heart AssociationNYHA\] classification);
•Human immunodeficiency virus (HIV) infection;
•Have active pulmonary tuberculosis;
•Have a history or current presence interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe pulmonary dysfunction, etc., which may interfere with the detection and management of suspected drug-related pulmonary toxicity;
•Have known active or suspected autoimmune diseases, except those in a stable state at the time of enrollment (not requiring systemic immunospressive therapy);
•Have received live vaccine treatment within 28 days before the first dose; seasonal flu vaccines are not included;
•Have received or need receive systemic corticosteroids (\> 10 mg/day prednisone equivalent dose) or other immunosuppressive drugs within 14 days before the dose or during the study. However, the following cases are allowed: patients with no active autoimmune diseases can use topical or inhaled corticosteroids, or hormone replacement therapy with a dose ≤ 10 mg/day prednisone equivalent dose;
•Have any active infection that requires systemic anti-infective within 14 days before the first dose; prophylactic antibiotic treatment (e.g., for urinary tract infections or chronic obstructive pulmonary disease) is not;

Arms & Interventions

Tislelizumab + SOX

Intervention: Tislelizumab + SOX

Outcomes

Primary Outcomes

Pathologic complete response rate (pCR)

Time Frame: 3 week

Secondary Outcomes

The R0 resection rate after radical operation(1 year)
Major Pathological response (MPR) after radical operation(From baseline to after radical operation)
Event Free Survival Rate from baseline to 1 year(from baseline to 1 year)
Overall Survival rate from baseline to 1 year(From baseline to 1 year)
Disease-related treatment failure rate from baseline to 1 year(From baseline to 1 year)
Objective response rate from baseline to 1 year(From baseline to 1 year)
Disease control rate from baseline to 1year(From baseline to 1year)
Correlation between PD-L1 expression, TMB level and T cell subsets in tumour tissue samples and efficacy.(6 week)
The safety from baseline to 1year(From baseline to 1year)