Clinical trial · Interventional
A Study of Intraperitoneal Paclitaxel in Combination With SOX Compared With SOX Alone in Gastric Cancer With Malignant Ascites
A Randomized Study of the Effect of First-line Intraperitoneal Paclitaxel in Combination With SOX Versus SOX Alone in Gastric Cancer Patients With Malignant Ascites
NCT03475615CI-TRIAL-00032216unknownPhase 3ClinicalTrials.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 study is designed to compare the efficacy of intraperitoneal paclitaxel in combination with SOX, with SOX alone in the first-line treatment of 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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SOXP
- interventionNames
- Drug: Oxaliplatin
- Drug: Paclitaxel
- Drug: S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)
- type
- ACTIVE_COMPARATOR
- label
- SOX
- interventionNames
- Drug: Oxaliplatin
- Drug: S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- 10 months
- description
- the internal between the date of enrollment and the date of death or last follow-up.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * had a histologically proven adenocarcinoma of the gastroesophageal junction, or stomach that was locally advanced (inoperable) or metastatic * malignant ascites(over pelvic cavity in CT scan and confirmed by cytology) * an Eastern Cooperative Oncology Group performance status of 0 to 2 * adequate renal, hepatic, and hematologic function Exclusion Criteria: * previous chemotherapy or radiotherapy (unless in the adjuvant setting) * uncontrolled cardiac disease, or other clinically significant, uncontrolled * coexisting illness or previous or concurrent cancer * HER2 positive and willing to use trastuzumab
References
Publications (0)
Data not yet available
No reference posted for this study.