Efficacy of HIPEC in the Treatment of Locally Advanced Gastric Cancer After radIcal Gastrectomy With D2

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

HIPEC-01 is a prospective, open, randomized multicenter phase III clinical study conducted in China. To determine the efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and postoperative chemotherapy. Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy followed by postoperative chemotherapy. Patients in both groups receive 6-8 cycles of postoperative systemic chemotherapy (XELOX or SOX regimens) and are followed up for 5 years or until death.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University; Affiliated Tumor Hospital of Guangzhou Medical University
• Collaborators: Central South University; Chinese PLA General Hospital; Guangdong Provincial Hospital of Traditional Chinese Medicine; Guangdong Provincial People's Hospital; Harbin Medical University; Hebei Medical University Fourth Hospital; Henan Cancer Hospital; Nanfang Hospital of Southern Medical University; Sun Yat-sen University; The Second Hospital of Hebei Medical University; Tianjin Medical University Cancer Institute and Hospital; Wuhan Union Hospital, China; Zhejiang Cancer Hospital
• Treatments: Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• 18 < age ≤ 70 years old

• Male or Non pregnant female

• The Eastern Cooperative Oncology Group (ECOG) status 0-1

• T3 or T4 gastric adenocarcinoma (visual determination according to AJCC 2010 7th edition)

• No distance metastasis, eligible for D2 lymphadenectomy

• Have not received cytotoxic chemotherapy, radiotherapy or immunotherapy

• White blood cells > 4,000/mm3

• neutrophils ≥ 1,500/mm3

• platelets ≥ 100,000/mm3

• hemoglobin>9g/l

• Alanine transaminase (ALT) and aspartate aminotransferase (AST) < or = 2.5 times upper limit of nominal (ULN)

• total bilirubin (TBIL) < 1.5 times ULN

• serum creatinine < 1 times ULN

• Having given written informed consent prior to any procedure related to the study

Exclusion Criteria:

• Have other cancer within 5 years

• Existence of distance metastasis during surgey (M1)

• Prior malignant tumors with detectable signs of recurrence or distant metastasis

• Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction<50%

• Epileptic seizures patients need medicine control

• Uncontroled mental disease or mental disorder

• Drug abuse or psychological or social factors affect the judgment of results

• Contraindication to any therapy contained in this regimen specific to the study

• Receiving other chemotherapy, radiotherapy or immunotherapy

• Without given written informed consent