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Spots Global Cancer Trial Database for HIPEC Combined With SOX and Sintilimab in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis

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Trial Identification

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

Official Title: The Efficacy and Safety of Hyperthermic Intraperitoneal Chemotherapy (HIPEC)Combined With SOX and Sintilimab in the Treatment of Advanced Gastric Cancer With Peritoneal Metastasis: A Prospective, Single-arm, Phase II Clinical Study

Study ID: NCT06213519

Study Description

Brief Summary: 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.

Detailed Description: To determine the efficacy and safety of HIPEC and systemic chemotherapy combined with sintilimab in the first-line treatment of advanced gastric cancer with peritoneal metastasis, patients will receive SOX regimen chemotherapy combined with sintilimab, once every three weeks. In the first cycle, HIPEC will be administrated, and HIPEC or intraperitoneal chemotherapy will be administrated in the second to third cycles according to the patient's condition. Then, another 3-cycle SOX regimen of systemic chemotherapy will be administrated. After the end of 6 cycles, patients will receive maintain treatment with a combination of S-1 and sintilimab until disease progression or intolerable toxicity.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Name: Kun Yang, M.D.

Affiliation: West China Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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