Conversion Therapy of Hyperthermic Intraperitoneal Chemotherapy Plus Chemotherapy and Chemotherapy in Stage IV Gastric Cancer

Last updated: January 26, 2022
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastric Cancer

Stomach Cancer

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT05228743
E20201130
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed as gastric adenocarcinoma by pathology and had not received any otheranti-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 orwithout ascites (ascites volume exceeding pelvic cavity but not reaching fullabdominal ascites)
  • Patients have adequate baseline organ and marrow function :hemoglobin≥9g/dL; absoluteneutrophil 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; prothrombintime-international normalized ratio≤1.5, and APTT(activated partial thromboplastintime) was within normal range; creatine ≤ 1.5 x ULN;
  • Written informed consent provided;

Exclusion

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 systemicdiseases, 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 cardiacinsufficiency;
  • Organ transplantation patients need immunosuppressive therapy;
  • Severe recurrent infections were not controlled or with other serious concomitantdiseases;
  • Patients got other primary malignant tumors (except curable skin basal cell carcinomaand cervical cancer in situ) except gastric cancer within 5 years; Psychiatric diseasewhich require treatment;
  • Within 6 months before study starts and in the process of this study, patientsparticipate in other clinical researches;
  • Patients with peripheral nervous system disorder or apparent mental disorders or hadthe history of central nervous system disorders;
  • Pregnant or lactating women, women of child-bearing potential, unwilling to useadequate contraceptive protection during the process of the study;
  • Patients without legal capacity,or medical/ethical reasons may influence the study tocontinue.

Study Design

Total Participants: 180
Study Start date:
September 01, 2020
Estimated Completion Date:
October 31, 2023

Study 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.

Connect with a study center

  • Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital

    Tianjin, Tianjin 300060
    China

    Active - Recruiting

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