Skip to content

A randomized controlled study of intraperitoneal hyperthermic perfusion chemotherapy (HIPEC) combined with intraperitoneal perfusion chemotherapy for gastric cancer with peritoneal metastasis

A randomized controlled study of intraperitoneal hyperthermic perfusion chemotherapy (HIPEC) combined with intraperitoneal perfusion chemotherapy for gastric cancer with peritoneal metastasis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056545
Enrollment
Unknown
Registered
2022-02-07
Start date
2022-03-01
Completion date
Unknown
Last updated
2024-10-07

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

Conditions

gastric cancer

Interventions

Group 1:Albumin binding paclitaxel+intraperitoneal hyperthermic perfusion chemotherapy
Group 2:Solvent paclitaxel+intraperitoneal hyperthermic perfusion chemotherapy
Group 3:Intravenous and intraperitoneal infusion of solvent paclitaxel combined with oral administration of S-1

Sponsors

Liaoning Provincial Cancer Hospital/Affiliated Cancer Hospital of Dalian University of Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. ECOG score = 3 months; 4. Histologically confirmed as gastric adenocarcinoma, with clear peritoneal metastasis (positive cytology of laparoscopic exploration, ascites puncture/peritoneal lavage fluid exfoliation), but without digestive tract obstruction; 5. The clinical staging was CT3-4NxM1 (M1 was peritoneal metastasis); 6. Laboratory examination can tolerate surgery and chemotherapy.

Exclusion criteria

Exclusion criteria: 1. Anti tumor therapy (surgery, chemotherapy, immunization, targeted therapy, etc.) has been carried out for gastric cancer in the past, but the time to this treatment is less than half a year; 2. In addition to peritoneal metastasis, there are other distant metastasis; 3. Patients with other malignant diseases in the last 5 years, excluding cured skin cancer and cervical carcinoma in situ; 4. If there is a history of uncontrolled epilepsy, central nervous system disease or mental disorder, the doctor shall judge whether the clinical severity hinders the signing of the informed consent or affects the compliance of the patient with oral drugs; 5. Clinically serious (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) Class II or more severe congestive heart failure or serious arrhythmia requiring drug intervention, or a history of myocardial infarction in the last 12 months; 6. Severe uncontrolled repeated infection includes abdominal infection, or other serious uncontrolled concomitant diseases; 7. Gastric cancer with complication (bleeding, perforation, obstruction) requiring emergency operation; 8. Patients with known deficiency of dihydropyrimidine dehydrogenase (DPD); 9 Patients who are allergic to paclitaxel or any of the drug ingredients of the project; 10. Pregnant or lactating patients; 11. Reproductive age patients (including men) who refuse to take contraceptive measures; 12. Extensive intra-abdominal adhesions due to various causes.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;Overall survival;

Secondary

MeasureTime frame
Incidence rate of adverse reactions;Objective response rate;Disease control rate;R0 resection rate;Quality of life;

Countries

China

Contacts

Public ContactZheng Zhichao, Zhang Tao

Liaoning Provincial Cancer Hospital/Affiliated Cancer Hospital of Dalian University of Technology

drzhengzhichao@126.com+86 18900918181/+86 18900918058

Outcome results

None listed

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