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Tislelizumab Combined with SOX and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Gastric Cancer with Peritoneal Metastasis: a Prospective Cohort Study

NCT06682182 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 74

Last updated 2024-11-12

No results posted yet for this study

Summary

The clinical trial aims to assess the efficacy and safety of Tislelizumab combined with the SOX regimen and HIPEC in treating gastric cancer with peritoneal metastasis. The primary and secondary objectives are as follows:

Primary objective: To evaluate the surgical conversion rate in patients with gastric cancer peritoneal metastasis treated with systemic chemotherapy plus immune checkpoint inhibitors combined with HIPEC.

Secondary objectives: To assess the safety, overall survival (OS), progression-free survival, tumor regression rate, incidence of adverse reactions during treatment, postoperative adverse reaction rates, and treatment efficacy of the combination therapy.

Participants will:

Be willing to receive SOX plus Tislelizumab combined with HIPEC treatment (exposure group), undergo one session of HIPEC followed by SOX plus immune checkpoint inhibitors (two cycles) 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, the next treatment plan will be discussed in a multidisciplinary team (MDT) meeting. Patients with progressive disease (PD) will also have their next treatment plan discussed in an MDT meeting.

Be willing to receive SOX combined with HIPEC treatment (observation group), undergo one session of HIPEC followed by SOX (two cycles) 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, the next treatment plan will be discussed in an MDT meeting. Patients with PD will also have their next treatment plan discussed in an MDT meeting.

Treatment details:

SOX: S-1 dosing 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 6 cycles.

Tislelizumab: 200mg IV, day 1, Q3W, for a total of 6 cycles. HIPEC: Docetaxel 75mg/m² in 3500ml normal saline, at 43°C for 60 minutes.

Conditions

  • Gastric Cancer with Peritoneal Metastasis

Interventions

DRUG

Tislelizumab+SOX

OX: S-1 dosing 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 6 cycles. Tislelizumab: 200mg IV, day 1, Q3W, for a total of 6 cycles. HIPEC: Docetaxel 75mg/m² in 3500ml normal saline, at 43°C for 60 minutes.

Sponsors & Collaborators

  • Southwest Hospital, China

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2026-12-01
Completion
2028-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06682182 on ClinicalTrials.gov