The Study of Intraperitoneal Docetaxel Plus S-1 for Malignant Ascites

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a clinical Study to evaluate the effect, survival benefit and safety of intraperitoneal docetaxel combined with oral S-1 for advanced gastric cancer with malignant ascites.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

1. Age 20-75years

2. Histologic confirmation of gastric adenocarcinoma

3. Positive peritoneal cytology or histological proven PM

4. Ascites in CT scan

5. Performance status (PS) ≤ 2 on Eastern Cooperative Oncology Group (ECOG) scale

6. Adequate bone marrow and organ functions as defined below:

Leucocyte≥3,000/ul Absolute neutrophil counts ≥1,500/uL Platelet≥100,000/uL Total bilirubin≤1.5mg/dl ALT，AST≤ 2x ULN serum creatinine ≤1.5mg/dl

7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

8. Provision of written informed consent

Exclusion Criteria:

1. Presence of non-curable factors such as distant metastasis to liver or lung except of peritoneum

2. Other severe medical conditions such as symptomatic infectious disease,active hemorrhage/bleeding, or obstructive bowel disease

3. Life expectation ≤ 3 months

4. With other malignant tumor

5. allergy to therapeutic drugs