Clinical trial NCT05228743: Conversion Therapy of Hyperthermic Intraperitoneal Chemotherapy Plus Chemotherapy and Chemotherapy in Stage IV Gastric Cancer
Official title: A Randomized, Multicenter, Controlled Study to Compare Hyperthermic Intraperitoneal Chemotherapy Plus Paclitaxel IP/IV, S-1 and Paclitaxel IP/IV，S-1 as Conversion Therapy for Gastric Cancer Patients With Peritoneal Metastasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Keywords: conversion therapy
HIPEC
peritoneal metastasis
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to compare Hyperthermic Intraperitoneal Chemotherapy combined with Chemotherapy and Chemotherapy as a conversion therapy for gastric Cancer Patients with peritoneal metastasis in Safety and Effectiveness.

Detailed description: Follow-up results from the PHOENIX study failed to show statistical superiority of intraperitoneal paclitaxel plus systemic chemotherapy. However, in the subgroup analysis, it can be seen that after correcting for the bias effect of ascites, the difference between the two groups was statistically significant, further proving the significance of ascites control on the prognosis of patients with gastric cancer peritoneal metastasis. Based on the existing data, for patients with moderate amount of ascites, the IP regimen is recommended to control ascites and relieve ascites. Symptoms, purpose of improving quality of life and prolonging survival. HIPEC is traditionally used to treat peritoneal cancer. Patients who diagnosed with gastric cancer with peritoneal metastasis were divided into two groups based on whether they underwent HIPEC. The primary endpoint is the R0 resection rate and the secondary endpoints are 1-year overall survival, and Safety.

Eligibility criteria: Inclusion Criteria:

* Diagnosed as gastric adenocarcinoma by pathology and had not received any other anti-tumor treatment such as radiotherapy and chemotherapy;
* ≥ 18 and ≤ 70 years of age; Eastern Cooperative Oncology Group Performance Status (ECOG): 0-1;
* Intraoperative pathological diagnosis was peritoneal metastasis (stage ≤ P1b), with or without ascites (ascites volume exceeding pelvic cavity but not reaching full abdominal ascites)
* Patients have adequate baseline organ and marrow function :hemoglobin≥9g/dL; absolute neutrophil count (ANC) ≥1,500/mm3; PLT(platelets)≥1000,000/mm3; total bilirubin ≤1.5×upper normal limit(ULN); AST ≤2.5 ×ULN, ALT ≤2.5 ×ULN; prothrombin time-international normalized ratio≤1.5, and APTT(activated partial thromboplastin time) was within normal range; creatine ≤ 1.5 x ULN;
* Written informed consent provided;

Exclusion Criteria:

* Diagnosed as Her-2(+++)/FISH(+) by pathology;
* With other distant metastasis(ovarian metastasis was excluded)
* Patients with Serious liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, hypertension and other chronic systemic diseases, heart disease with Clinical symptoms, such as congestive heart failure, coronary heart disease symptoms, drug is difficult to control arrhythmia, hypertension, or six months had a myocardial infarction attack, or cardiac insufficiency;
* Organ transplantation patients need immunosuppressive therapy;
* Severe recurrent infections were not controlled or with other serious concomitant diseases;
* Patients got other primary malignant tumors (except curable skin basal cell carcinoma and cervical cancer in situ) except gastric cancer within 5 years; Psychiatric disease which require treatment;
* Within 6 months before study starts and in the process of this study, patients participate in other clinical researches;
* Patients with peripheral nervous system disorder or apparent mental disorders or had the history of central nervous system disorders;
* Pregnant or lactating women, women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study;
* Patients without legal capacity,or medical/ethical reasons may influence the study to continue.

Primary outcomes:
measure: R0 resection rate
timeFrame: 1 year
Secondary outcomes:
measure: 1 year overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
state: Tianjin
Study officials:
References: