Clinical trial · Interventional
Weekly Docetaxel/Irinotecan for Non-resectable Gastric Cancers After Cisplatin Plus 5-FU/Leucovorin
Phase II Trial of Consolidation or Salvage Chemotherapy by Using Weekly Docetaxel/Irinotecan After Cisplatin Plus Weekly 24-Hour Infusion of High-dose 5-Fluorouracil/Leucovorin for Non-resectable Gastric Cancers
- 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)
In this study, the investigators will use P-HDFL, a regimen with high tumor remission rate (\~ 60-70%) and with only modest treatment-associated toxicities, as induction chemotherapy for patients with non-resectable gastric cancer. For those patients who have achieved complete response (CR) or partial response (PR), DI will be used to "consolidate" the remission. For those patients who fail to achieve remission by P-HDFL, DI will be used as salvage chemotherapy. The efficacy and toxicities of DI in these two settings will be evaluated in this prospective study.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel-Irinotecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A, 2, III
- description
- Weekly Docetaxel-Irinotecan for Inoperable Gastric Cancers After P-HDFL
- interventionNames
- Drug: Docetaxel-Irinotecan
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- Five years
Secondary outcomes (1)
- measure
- Objective response rates (CR, PR)
- timeFrame
- Confirmed objective response after 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed gastric adenocarcinoma 2. Measurable or evaluable disease 3. No previous C/T 4. Age 16 \~ 75 years 5. Karnofsky Performance Status of 60% 6. 4 weeks after R/T 7. Adjuvant C/T: the last dosing of C/T 6 months before enrollment 8. WBC \>= 4,000, platelets \>= 100K, Creatinine \<= 1.5mg/dl and proteinuria \<1+, normal serum bil, transaminase \<= 3.5x ULN, TG \> 70mg/dl Exclusion Criteria: 1. CNS metastasis 2. Patients receive concomitant anti-cancer C/T or R/T 3. Patients who are pregnant and with an expected life expectancy less than 3 months 4. Symptomatic heart disease, active infection, extensive liver disease, or liver cirrhosis
References
Publications (0)
Data not yet available