Clinical trial · Interventional
Liposomal Paclitaxel Combined Nedaplatin in Treatment of Advanced or Recurrent Esophageal Carcinoma
Phase II Study of Liposomal Paclitaxel With Nedaplatin as First-line in Advanced or Recurrent Esophageal Carcinoma
NCT02861690CI-TRIAL-00023423completedPhase 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)
The purpose of this study is to evaluate the safety, tolerance and efficacy of Liposomal Paclitaxel With Nedaplatin as First-line in patients with Advanced or Recurrent Esophageal Carcinoma
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 |
|---|---|---|---|
| Esophageal Carcinoma | Esophageal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liposomal Paclitaxel | Drug | Paclitaxel Liposome | ALIAS |
| Nedaplatin | Drug | Nedaplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- patients received Liposomal Paclitaxel and Nedaplatin every 21 days until the presence of progressive disease or unacceptable toxicity
- interventionNames
- Drug: Liposomal Paclitaxel
- Drug: Nedaplatin
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- from date of baseline measured to date of first CT evaluation，Up to 3 months
- description
- To assess the response rate of Liposomal Paclitaxel and Nedaplatin in patients with pretreated advanced or recurrent esophageal carcinoma. Possible evaluations include: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Inclusion Criteria: 1. histological confirmed advanced metastatic or recurrent esophageal cancer 2. age between 18 and 80 years 3. ECOG performance status of 0 to 2 4. life expectancy ≥ 12 weeks 5. has evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 6. at least one prior chemotherapy regimen 7. adequate bone marrow function as defined by absolute neutrophil count more than or equal to 2000/mm3 8. platelet count more than or equal to 100,000/mm3 and hemoglobin more than or equal to 8 g/dL 9. adequate renal function defined by creatinine less than or equal to 1.25 × upper limit of normal(ULN) and creatinine clearance more than or equal to 60mL/min, 10. adequate liver function defined by bilirubin less than or equal to 1.0×ULN aspartate transferase(AST) and alanine transferase(ALT) less than or equal to 2.5 ×ULN. Exclusion Criteria: 1. other primary malignancy 2. symptomatic central nervous system metastasis 3. pregnancy or lactation 4. cardiovascular events such as myocardial infarction in the previous 6 months or congestive heart failure 5. ongoing infection
References
Publications (0)
Data not yet available
No reference posted for this study.