Esophageal Carcinoma
Conditions
Keywords
Esophageal Cancer, nedaplatin, Liposomal Paclitaxel
Brief summary
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
Detailed description
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.Patients receive Liposomal Paclitaxel 175mg/m2 and Nedaplatin 80mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.
Interventions
Patients received Liposomal Paclitaxel 175mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.
DRUGNedaplatin
Patients received Nedaplatin80mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | from date of baseline measured to date of first CT evaluation，Up to 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | from date of baseline to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | Progression-free survival (PFS) is defined as the time from the date of study enrollment to the date of objectively determined PD or death from any cause, whichever comes first. For patients who are still alive at the time of analysis, and who do not have PD, PFS will be censored at the date of the last objective progression-free disease assessment. |
| overall survival | baseline to date of death from any cause，up to 2 approximately years | Overall survival is defined as the time from the date of study enrollment to the date of death from any cause. |
| Number of Participants With Adverse Events (Toxicity) | Up to 30 days post last dose | Number of participants with treatment-related adverse events as assessed by CTCAE. |
Countries
China
Outcome results
None listed