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.
Patients with pathologically confirmed Her-2 negative gastric adenocarcinoma who have not received chemotherapy, radiotherapy, or other anti-cancer treatments before the start of the clinical trial.
Patients who are receiving other drug clinical trials or have participated in any drug clinical trials within one month before enrollment.
Patients with pathologically confirmed Her-2 negative gastric adenocarcinoma who have not received chemotherapy, radiotherapy, or other anti-cancer treatments before the start of the clinical trial.American Joint Committee on Cancer (AJCC) 8th edition TNM staging of T1-4aNxM1 (limited to peritoneal metastasis or the presence of ascites beyond the pelvis), without obstruction, perforation, or bleeding risk. Peritoneal Cancer Index (PCI) ≤ 20.
Cohort
Prospective
Tislelizumab+SOX
DrugOX: 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.
Conversion surgery rate
Conversion surgery rate (the proportion of enrolled patients achieving R0 resection after treatment) for gastric cancer patients with peritoneal metastasis treated with Tislelizumab combined with HIPEC
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This trial is not recruiting at the moment. You can still explore other options:
