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A prospective randomized controlled trial of D2 radical resection combined with hyperthermic intraperitoneal chemotherapy (HIPEC) in the treatment of advanced gastric cancer

A prospective randomized controlled trial of D2 radical resection combined with hyperthermic intraperitoneal chemotherapy in the treatment of advanced gastric cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055966
Enrollment
Unknown
Registered
2022-01-30
Start date
2017-01-01
Completion date
Unknown
Last updated
2024-07-15

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

Conditions

gastric cancer

Interventions

Experimental group:D2 radical surgery +HIPEC twice + systemic chemotherapy 8 cycles
The control group:D2 radical surgery +systemic chemotherapy 8 cycles

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed patients did not receive chemotherapy or radiotherapy before the clinical trial; 2. Pathological diagnosis of gastric adenocarcinoma; 3. Patients with advanced stage T(4), N(0-3), M0 (ENDOSCOPIC ultrasound or CT) (AJCC, 7th edition, 2010); 4. Male or non-pregnant female; 5. Aged between 18 and 75 years; 6. Before enrollment, hemodynamic indexes (including blood count, liver and kidney function) were normal. For example, WBC > 3.5 x 10^9/L, neutrophils > 1.5 x 10^9/L, platelets > 100 x 10^9/L, bilirubin < 1.5 times the upper limit of normal, glutamic-oxalacetic transaminase and glutamic-pyruvic transaminase creatinine < 2 times the upper limit of normal, serum creatinine < 1.2mg/d; 7. Cardiac function was good before enrollment, no myocardial infarction occurred within half a year, hypertension and other coronary heart diseases were well controlled, and no other uncontrollable benign diseases; 8. ECOG: 0-1; 9. Did not participate in other research projects before and during treatment; 10. Informed consent of the patient has been obtained.

Exclusion criteria

Exclusion criteria: 1. Patients with other malignant tumors within 5 years; 2. Patients with peritoneal metastasis; 3. Other serious diseases that are difficult to control at the same time (including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction below 50%, serious liver disease, kidney disease, infectious disease or uncontrolled diabetes or hypertension, etc.); 4. Received anticancer drugs in other clinical trials; 5. Failure to comply or inability to complete the entire trial treatment; 6. Extensive adhesions in the abdominal cavity; 7. Para-aortic lymph nodes or retropancreatic lymph nodes metastases; 8. Refusal to sign informed consent.

Design outcomes

Primary

MeasureTime frame
The 3-year and 5-year survival rates;

Secondary

MeasureTime frame
The progression-free survival rate;The recurrence rate;The safety of the treatment;

Countries

China

Contacts

Public ContactDu Yian

Zhejiang Cancer Hospital

abdsurg@163.com+86 571 88128041

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026