Clinical trial · Interventional
Sequential HIPEC of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis
Phase 2 Study of Sequential Hyperthermic Intraperitoneal Chemotherapy of Oxaliplatin and Paclitaxel for Gastric Cancer Patients With Peritoneum Metastasis or Positive Free Cancer Cells in Abdomen
- 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)
The recurrence and metastasis of peritoneum is always the lethal consequence for gastric cancer patients, and there is no effective therapy until now. It has been reported by Dr.Fujimoto that intraperitoneal chemotherapy plus hyperthermic therapy, which called hyperthermic intraperitoneal chemotherapy (HIPEC), can eliminate and suppress the free cancer cells and tiny metastasis in abdomen. Refer to the experience of systematic chemotherapy, HIPEC with combination regimen would have a brighter prospect. In this study, the investigators would use Oxaliplatin and paclitaxel sequent as HIPEC regimen. The safety and overall survival would be observed and evaluated.
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 |
| Metastases to Perineum | Gastric Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HIPEC
- interventionNames
- Drug: Oxaliplatin
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- every 3 month postoperation up to 24 months
Secondary outcomes (1)
- measure
- Safety
- timeFrame
- every 3 month postoperation up to 24 months
- description
- Number of Participants with Adverse Events(III or IV grades according to NCI-CTC)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proved gastric adenocarcinoma. * Peritoneum metastasis is observed or suspected by laparoscopy or radiologic examination,or free cancer cells are detected in peritoneal lavage liquid. * Potentially resectable gastric cancer. * ALT, AST \< 80U/L; Total Bilirubin \< 30μmol/L; WBC \> 4x10\^9/L; PLT \> 100x10\^9/L; Cr \< 1.5 fold normal value. * ECOG 0-2 points. * Expected survival time longer than 3 months. * Informed consent. Exclusion Criteria: * Recurrent gastric cancer. * Pregnant or lactating women. * Allergic to oxaliplatin or paclitaxel. * Abnormal liver/kidney function. * Serious heart/metabolic disease.
References
Publications (0)
Data not yet available