Esophageal Squamous Cell Carcinoma
Conditions
Keywords
ESCC
Brief summary
Assess the efficacy and safety of S1 combined with cisplatin in treatment of recurrence/metastasis of ESCC
Interventions
DRUGS1 combined with cisplatin
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | from the first cycle of treatment (day one) to two month after the last cycle |
Countries
China
Outcome results
None listed