Clinical trial · Interventional
The Study of Intraperitoneal Docetaxel Plus S-1 for Malignant Ascites
The Study of Intraperitoneal Docetaxel Plus S-1 for Malignant Ascites Due to Far Advanced Gastric Cancer
NCT02779608CI-TRIAL-00025592unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peritoneal Metastasis | — | UNRESOLVED | — |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intraperitoneal docetaxel | Drug | — | UNRESOLVED |
| oral S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- intraperitoneal docetaxel and oral S-1
- description
- Docetaxel is diluted in 1litre normal saline and administered intraperitoneal（IP）at a dose of 60 mg/m2 over 1 hour on day 1. S-1 was administered orally twice daily at a dose of 40mg/m2 per day for 14 consecutive days, followed by 7 days of rest. Intervention: Drug: Intraperitoneal docetaxel Intervention：Drug：Oral S-1
- interventionNames
- Drug: intraperitoneal docetaxel
- Drug: oral S-1
Primary outcomes (1)
- measure
- response rate of ascites
- timeFrame
- 9 weeks
- description
- From date of enrollment to three cycles of treatment，the ascites is evaluated by the Japanese conventional five-point method
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.