HIPEC Combined With SOX and Sintilimab in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis

ConditionsPeritoneal Metastases Gastric Cancer

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorSichuan University

About this trial

The prognosis of patients with peritoneal metastasis from gastric cancer is extremely poor. Although chemotherapy combined with immunotherapy has achieved promising efficacy in the first-line treatment of advanced gastric cancer, patients with peritoneal metastasis benefit less from this regimen. Hyperthermic intraperitoneal chemotherapy (HIPEC) represents a novel treatment option, which maintains the high concentration of drugs in the abdominal cavity, and improve the anti-tumor efficacy of chemotherapy drugs through the thermo-thermal effect. The purpose of this study is to investigate the efficacy and safety of HIPEC and systemic chemotherapy combined with sintilimab in the first-line treatment of advanced gastric cancer and gastroesophageal junction adenocarcinoma with peritoneal metastasis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years.

Unresectable gastric/gastroesophageal junction adenocarcinoma diagnosed with peritoneal metastasis through laparoscopic exploration and pathological or cytological examination;

No previous antitumor treatment.

Agree to provide blood/tissue specimens.

Disqualifiers

Undergoing other drug clinical trials or having participated in any drug clinical trials one month before enrollment.

Active autoimmune disease or history of refractory autoimmune disease.

Receiving corticosteroids (> 10mg/d prednisone or equivalent dose of steroids) or other systematic immunosuppression therapies within 14 days before enrollment, excluding the following therapies: steroid hormone replacement therapy (≤10mg/d); local steroid therapy; and short-term, prophylactic steroid therapy for preventing allergies or nausea and vomiting.

Congestive heart failure > New York Heart Association (NYHA) class 2;

Trial design

Design model

Single group

Treatments tested in this trial

S-1, Oxaliplatin sintilimab HIPEC
Drug
1. Exploratory laparoscopy or laparotomy 2. SOX regimen (oxaliplatin 100mg/m2, d1, S-1 BSA\<1.25m2 40mg, twice a day; 1.25m2 ≤ BSA \< 1.5m2 50mg, twice a day; BSA ≥ 1.5m2 60mg, twice a day; d1-14) chemotherapy combined with sintilimab (200mg, d1), once every three weeks. 3. In the first cycle, HIPEC (paclitaxel 80 mg/m2, d1-d3) will be administrated, 4. In the second and third cycles, HIPEC or intraperitoneal chemotherapy (paclitaxel 80 mg/m2, d1) will be administrated according to the patient's condition. 5. Another 3-cycle SOX regimen of systemic chemotherapy. 6. After the end of 6 cycles, maintain treatment with a combination of S-1 and sintilimab until disease progression or intolerable toxicity.

Treatment groups

69 Participants

are divided into 1 treatment group

Group A: SOX+sintilimab+HIPECExperimental treatment 1 intervention

Trial outcomes