S1 Combined With Cisplatin in Treatment of Recurrence/Metastasis of ESCC Open-label Single Center Phase II Clinical Study

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Assess the efficacy and safety of S1 combined with cisplatin in treatment of recurrence/metastasis of ESCC

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Cisplatin

Criteria

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