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A clinical study of intraperitoneal and intravenous Nab-Paclitaxel plus S-1 for gastric cancer with peritoneal metastasis complicated with malignant ascites

A clinical study of intraperitoneal and intravenous Nab-Paclitaxel plus S-1 for gastric cancer with peritoneal metastasis complicated with malignant ascites

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036223
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-08-26
Completion date
Unknown
Last updated
2020-09-07

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: intraperitoneal and intravenous Nab-Paclitaxel plus S-1

Sponsors

The Fourth Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subjects aged over 18 years old; 2. Patients with locally advanced or metastatic / recurrent gastric adenocarcinoma confirmed by histology; 3. Patients with peritoneal metastasis complicated with malignant ascites who need to be diagnosed by peritoneal free cancer cell test or laparoscopy; 4. Patients whose solid tumor size can be measured according to the solid tumor response evaluation standard (recist1.1 standard); 5. ECOG = 1.5 * 10^9 / L, platelet >= 100 * 10^9 / L, hemoglobin >= 90 g / L; 7. Liver and kidney function: serum creatinine <= 1.5 times of upper limit of normal value; AST and alt <= 2.5 times of upper limit of normal value; total bilirubin <= 1.5 times of upper limit of normal value; 8. Patients have good compliance with the planned treatment, can understand the research process of this study and sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who received targeted drug therapy or immunotherapy within three months before enrollment; 2. Patients who received palliative chemotherapy within one month before enrollment; 3. Patients with uncontrolled hypertension, congestive heart failure or myocardial infarction within six months; 4. Patients with any other malignant tumor (except ovarian cancer and colon cancer) in the past 5 years; 5. Patients with untreated central nervous system diseases or symptomatic central nervous system metastases; 6. Pregnant or lactating women of childbearing age who refuse to take appropriate contraceptive measures during this trial; 7. Patients who need immunosuppressive therapy after organ transplantation; 8. Patients with uncontrolled severe infection or other serious accompanying diseases; 9. The investigator judged the patients who were not suitable for the study.

Design outcomes

Primary

MeasureTime frame
Objective remission rate of ascites;Objective remission rate of tumour;Safety;

Secondary

MeasureTime frame
Disease control rate of ascites;Disease control rate of tumour;Overall survival;Progression free survival;

Countries

China

Contacts

Public ContactYin Fei

The Fourth Hospital of Hebei Medical University

yinfei_4y@163.com+86 13831120022

Outcome results

None listed

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