Clinical trial · Interventional
The Study of Irinotecan Plus Epirubicin as the Second-line Chemoregime for Advanced Gastric Cancer
NCT01964027CI-TRIAL-00012410SIEGunknownPhase 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 study is to determine the response rate and safety profile of irinotecan plus epirubicin as the second-line chemotherapy for advanced gastric cancer and fully evaluate the feasibility and effectiveness of the regime.
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 | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| second line chemoregime for advanced gastric cancer | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Irinotecan plus epirubicin
- description
- Irinotecan(Camptosar)150mg /m2 d1,（intravenous infusion of 30-90 minutes) + epirubicin(Pharmorubicin) 50mg/m2 (total dose does not exceed 700mg/m2) every 21days for 1 treatment \* 6 cycles as the second line chemoregime for advanced gastric cancer
- interventionNames
- Drug: second line chemoregime for advanced gastric cancer
Primary outcomes (1)
- measure
- PFS and OS
- timeFrame
- 2 years
- description
- Evaluation progression-free survival (PFS) and overall survival (OS) RECIST(Response Evaluation Criteria In Solid Tumors)1.1: 1. Complete response (CR) 2. Partial response (PR) 3. Stable disease(SD) and progression disease(PD) 4. CR + PR is efficient.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion criteria: * Aged between 18 to 70 years * The pathologically confirmed gastric adenocarcinoma and the failure of first-line chemotherapy * Measurable lesions outside the stomach * ECOG(Eastern Cooperative Oncology Group ) score between 0 to 1 * Expected survival time of at least 3 months * Subjects receiving treatment for other damage caused has been restored, which it accepted the nitroso or mitomycin interval\> 6 weeks, the acceptance of other cytotoxic drugs, radiotherapy or surgery\> = 4 weeks, and the wound has completely healed. No bleeding, no nervous system transferred * Blood and organ function was normal Exclusion criteria: * Comorbid with other malignant tumors * Pregnant and lactating women * with the disease of endangering patient's safety and affecting the completion of the study * Patients suffering from high blood pressure by antihypertensive treatment cannot control (systolic blood pressure\> 140mmhg, diastolic blood pressure\> 90mmhg,) there is more than Class I and Class I arrhythmia coronary heart disease, with more than Class I heart dysfunction * Major organ failure, such as decompensated heart and lung failure, liver failure, renal failure and patients with intestinal obstruction ipate in other clinical trials of patients in the past four weeks * Participated in clinical trials with other drugs or using other drugs during past 4 weeks * Lesions which can't be measured such as pleural effusion, ascites, peritoneal cancer lesions, diffuse liver and bone metastases violation, brain metastasis
References
Publications (0)
Data not yet available
No reference posted for this study.