Hyperthermic Intraperitoneal Chemotherapy for Advanced Gastric Cancer With Peritoneal Metastatis

Phase 2

• Conditions: Exploratory Behavior; Hyperthermic Intraperitoneal Chemotherapy; Stage IV Gastric Cancer With Metastasis
• Interventions: Drug: Without Hyperthermic Intraperitoneal Chemotherapy; Drug: Hyperthermic Intraperitoneal Chemotherapy

• Registration Number: NCT03604614
• Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

Brief Summary

The incidence rate of gastric cancer is high in Southeast Asia, so is the mortality rate.Due to the lack of specific performance, about 5%-20% of patients have found peritoneal metastases at the time of first diagnosis.At present, clinical studies on HIPEC in the treatment of patients with advanced gastric cancer peritoneal metastasis are almost related to abdominal perfusion after laparoscopic gastrectomy.Herein, we conduct a single-centre randomized controlled trial to explore the safety and feasibility of laparoscopic exploration combined with HIPEC in the treatment of advanced gastric cancer with peritoneal metastasis.

Detailed Description

Gastric cancer is one of the most common digestive tumors in the world.In China, advanced gastric cancer with severe local progression or distant metastasis is more common.Gastric cancer with peritoneal carcinomatosis has an extremely poor prognosis,with a median survival of less than 6 months.Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is currently a treatment for malignant tumors in the abdominal cavity and prevents tumor recurrence and metastasis.Studies have shown that hyperthermic intraperitoneal perfusion chemotherapy (HIPEC) has good clinical efficacy in the prevention and treatment of peritoneal metastasis of gastric cancer and its associated malignant ascites.Therefore,we conduct a single-centre randomized controlled trial to explore the safety and feasibility of HIPEC in the treatment of advanced gastric cancer with peritoneal metastasis. The metahnism of HIPEC is taking advantage of the difference in temperature sensitivity between cancer cells and normal cells. Perfusion of the abdominal cavity with a chemical fluid of the appropriate temperature can be performed. Suitable high temperatures can directly kill tumor cells.It is generally believed that the optimal temperature for the treatment of tumors is 42.5°C to 44°C.In this study,we set the temperature 43°C. Paclitaxel is a novel broad-spectrum antitumor drug,which has a unique anti-cancer mechanism.We use Paclitaxel as peritoneal hyperthermic perfusion chemotherapy drugs.The chemotherapy is SOX(Teggio and Oxaliplatin),.The primary endpoint is PFS. Secondary endpoints are one-year OS、canversion rate and ascites assessment. A phase III study PHOENIX-GC trial had finished enrollment,and the conclusion was the median OS 17.7 and 15.2 months respectively for IP and SP.The primary analysis did not show the statistical superiority of the IP regimen.The sensitivity analysis IP considering the imbalance of ascites, suggested clinical efficacy of IP PTX in gastric cancer with peritoneal metastasis. For this reason,we conduct a trial to explore the safety and feasibility of HIPEC in the treatment of advanced gastric cancer with peritoneal metastasis.

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2017-08-24
• Study First Submitted: 2018-06-14
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-20
• Last Update Submitted: 2018-07-20
• Study First Posted: 2018-07-27
• Last Update Posted: 2018-07-27
• Study Completion: 2020-08-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Primary gastric adenocarcinoma diagnosed pathologically by endoscopic biopsy；
• Laparoscopic exploration of patients with advanced gastric adenocarcinoma of peritoneal metastasis；
• Eastern Cooperative Oncology Group (ECOG): 0 ot 1；
• American Society of Anesthesiologists （ASA） score: I to Ⅲ；
• Patient informed consent。

Exclusion Criteria

• Pregnancy or female in suckling period；
• Severe mental illness；
• Preoperative imaging or intraoperative exploration reveals distant blood, liver, lung, and brain metastases；
• 5 years of history of other malignant diseases；
• A history of unstable angina or myocardial infarction within 6 months；
• History of cerebral infarction or cerebral hemorrhage within 6 months；
• A history of sustained systemic corticosteroid treatment within 1 month；
• Emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor；
• Pulmonary function test FEV1 <predicted value 50%。

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Without HIPEC	Without Hyperthermic Intraperitoneal Chemotherapy	Without Hyperthermic Intraperitoneal Chemotherapy，Only SOX（Tiggio+Oxaliplatin ）
HIPEC and chemotherapy	Hyperthermic Intraperitoneal Chemotherapy	Hyperthermic Intraperitoneal Chemotherapy and SOX（Tiggio+Oxaliplatin ）

Primary Outcome Measures

Name	Time	Method
PFS	From date of randomization until the date of first documented progression or date of death for tumor cause, whichever came first, assessed 7 months	Progression-free survival

Secondary Outcome Measures

Name	Time	Method
1-year survival	one year	1-year overall survival rate
Ascites assessment	Intraoperative	Ascites assessment during surgery
Median survival	From date of randomization until only 50% of individuals living for tumor cause, assessed 2 years	Median Survival Time

Trial Locations

Locations (1)

Guangdong Province Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China