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A single-center phase II study for D2 radical combined intraoperative HIPEC after surgery and adjuvant chemotherapy on the survival of patients with advanced gastric adenocarcinoma

A single-center phase II study for D2 radical combined intraoperative HIPEC after surgery and adjuvant chemotherapy on the survival of patients with advanced gastric adenocarcinoma

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-16009848
Enrollment
Unknown
Registered
2016-11-14
Start date
2016-11-15
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

The treatment group:Hyperthermic Intraperitoneal Chemotherapy

Sponsors

Second Affiliated Hospital, Zhejiang University College of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patient with no chemotherapy or radiotherapy prior to the start of the clinical trials, the pathological diagnosis of gastric cancer, patients with clinical stage of progress stage T3/4 (endoscopic ultrasound and enhancement CT and ultrasound imaging) (AJCC seventh edition in 2010), male or non pregnancy women, ranging in age from 18 to 70 years old, hematologic studies: 4000 cells/mm3 WBC count, neutrophil 1500 cells/mm3, platelet count > 100000 cells/mm3, hemoglobin > 9 g/l, biochemical examination: total bilirubin < 1.5 times that of the upper limit of normal, AST, ALT < 2.5 times the normal limit, creatinine < 1.5 times that of the normal limit function status: 0-2 (ECOG), has obtained the patient's informed consent.

Exclusion criteria

Exclusion criteria: Itraoperative intraperitoneal free cancer cells and peritoneal cancer was found in patients. patients with recurrence and distant metastasis, and other difficult to control the serious disease (including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, is difficult to control high blood pressure, etc.) were excluded. Others were treated with other clinical trials of cancer drugs. nonadherence or researchers believe could not complete the entire test treatment, extensive adhesion of abdominal cavity existence, refuse to sign a consent form.

Design outcomes

Primary

MeasureTime frame
1, 3, 5 years overall survival rate;

Countries

China

Contacts

Public ContactWu Dan

Second Affiliated Hospital, Zhejiang University College of Medicine

wudan_wcwk@163.com+86 03758130560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026