Clinical trial · Observational
Nonintervention Study on Peritoneal Metastasis of Stage IV Gastric Cancer
Prospective and Non-interventional Study on Peritoneal Metastasis of Stage IV Gastric Cancer
NCT03237507CI-TRIAL-00028907unknownClinicalTrials.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 non-interventional study，aim to observe the safety and efficiency of different treatment regimen for peritoneal metastasis of Stage IV gastric cancer in the real world
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IV Gastric Cancer With Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperthermic Intraperitoneal | Device | — | UNRESOLVED |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Chemotherapy Group
- description
- chemotherapy treatment（S-1 and Oxaliplatin） for patients until disease progress
- interventionNames
- Drug: S-1
- Drug: oxaliplatin
- label
- Chemotherapy plus HIPEC Group
- description
- Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy
- interventionNames
- Drug: S-1
- Drug: oxaliplatin
- Device: Hyperthermic Intraperitoneal
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- PFS: Progression Free Survival
- timeFrame
- through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 ≤ age * Patients with histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma, stage IV with peritoneal metastasis * Didn't received any prior systemic chemotherapy * Signed informed consent Exclusion Criteria: * History of hypersensitivity to fluoropyrimidines, Tegafur，Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product * Pregnancy or lactation women, * Inadequate hematopoietic function： WBC≦3,500/mm3; ANC≦1,500/mm3; Platelet≦80,000/mm3 * Inadequate organ function which is defined as below: Total bilirubin \>2 pper limit of normal range (ULN); ALT / AST \> 2.5 upper limit of normal range (ULN); serum creatinine \> 1.5 mg/dL, and Ccr \> 60 ml/min (estimated by Cockcroft-Gault formulation); * Symptomatic peripheral neuropathy * Receiving a concomitant treatment with other fluoropyrimidines * Fluoropyrimidines (DPD) congenital absence * Other Situations which physicians suggesting are inadaptable for enrollment
References
Publications (0)
Data not yet available
No reference posted for this study.