RecruitingNCT06760858

A Prospective Cohort Study on the Treatment of Locally Advanced Gastric Cancer

A Prospective Cohort Study on the Treatment of Locally Advanced Gastric Cancer with SOX Plus Tislelizumab Combined with HIPEC

Sponsor

Southwest Hospital, China

Enrollment

122 participants

Start Date

Dec 1, 2024

Study Type

OBSERVATIONAL

Conditions

Gastric Cancer, Gastroesophageal Junction Cancer

Summary

The clinical trial aims to assess the efficacy and safety of Tislelizumab combined with the SOX regimen and HIPEC in treating locally advanced gastric cancer. The primary and secondary objectives are as follows: To evaluate the 3-year disease-free survival (DFS) in patients with locally advanced gastric cancer treated with systemic SOX chemotherapy plus Tislelizumab and HIPEC. To assess the major pathological response (MPR) in these patients. Secondary objectives include safety, pathological complete response (pCR), progression-free survival (PFS), tumor regression grade (TRG), overall survival (OS), incidence of adverse reactions during treatment, postoperative adverse reactions, and treatment efficacy. Participants will: Be willing to receive SOX plus Tislelizumab combined with HIPEC treatment (exposure group), undergo HIPEC followed by SOX and Tislelizumab to achieve stable disease (SD), partial response (PR), or complete response (CR). Patients who can undergo surgery after the second exploration will receive surgery and HIPEC treatment. If surgery is not possible, a multidisciplinary team (MDT) discussion will follow to determine the next treatment plan. Patients with progressive disease (PD) will also have an MDT discussion to determine the subsequent treatment. Be willing to receive SOX combined with HIPEC treatment (observation group), undergo HIPEC followed by SOX to achieve SD, PR, or CR. Patients who can undergo surgery after the second exploration will receive surgery and HIPEC treatment. If surgery is not possible, an MDT discussion will follow to determine the next treatment plan. Patients with PD will also have an MDT discussion to determine the subsequent treatment. Treatment details: SOX: S-1 dosage based on body surface area (BSA): \<1.25m², 40 mg bid orally, 1.25-1.5m², 50 mg bid orally, ≥1.5m², 60mg bid orally, days 1-14; Q3W; Oxaliplatin 130mg/m² IV day 1, for a total of 3 cycles. Tislelizumab: 200mg IV, day 1, Q3W, for a total of 3 cycles. HIPEC: Docetaxel: 120mg, day 1, day 3.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is following patients with locally advanced stomach (gastric) cancer — specifically those whose tumors do not have HER2 protein — to see how well different standard treatments work in real-world practice. **You may be eligible if...** - You are between 18 and 80 years old - You have newly diagnosed HER2-negative gastric cancer (stomach adenocarcinoma) - Your cancer is locally advanced (stage T4a) but has not spread to distant organs - You have not yet had any chemotherapy, radiation, or other cancer treatments - You are in good general health (ECOG 0–1) - Your blood counts and organ function are adequate **You may NOT be eligible if...** - You have HER2-positive stomach cancer - You have already started any cancer treatment - Your cancer has spread to distant organs (metastatic disease) - You have significant tumor complications like bleeding, obstruction, or perforation risk Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTislelizumab

Tislelizumab: 200mg IV, day 1, Q3W, for a total of 3 cycles.

DRUGSOX

SOX: S-1 dosage based on body surface area (BSA): \<1.25m², 40 mg bid orally, 1.25-1.5m², 50 mg bid orally, ≥1.5m², 60mg bid orally, days 1-14; Q3W; Oxaliplatin 130mg/m² IV day 1, for a total of 3 cycles.

DEVICEHIPEC

HIPEC: Docetaxel: 120mg, day 1, day 3.