Status:
COMPLETED
S1 Combined With Cisplatin in Treatment of Recurrence/Metastasis of ESCC Open-label Single Center Phase II Clinical Study
Lead Sponsor:
Fudan University
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Assess the efficacy and safety of S1 combined with cisplatin in treatment of recurrence/metastasis of ESCC
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Joined the study voluntarily and signed informed consent form;
- Age 18-75
- .Presence of at least one index lesion measurable by CT scan or MRI
- recurrence/metastasis of Esophageal carcinoma or gastroesophageal cancer confirmed by pathology
- No radiotherapy, chemotherapy or other treatments prior to enrollment
- PS ECOG 0-1
- Life expectancy of more than 3 months
- ANC≥2×109/L，PLT≥100×109/L，Hb≥90g/L
- Cr≤1.0×UNL
- TBIL≤1.25×UNL； ALT/AST≤2.5×UNL，with hepatic metastases ALT/AST≤5.0×UNL；AKP≤2.5×UNL
- Exclusion Criteria:
- there is radical cure of the cancer
- uncontrolled chronic diarrhea and esophageal obstruction
- Neurological or mental abnormalities Influence of cognitive ability include central nervous system metastases
- Severe complication(s), e.g.,uncontrolled active infection,myocardial infarction,hypertension,arrhythmia,stenocardia
- Patient who has metastasis except cured skin basal cell carcinoma and carcinoma in situ of cervix
- accept other antitumor therapy •Female patients during their pregnant and lactation period, or patients without contraception
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01854749
Start Date
November 1 2011
Last Update
February 23 2016
Active Locations (1)
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1
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032