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

Fudan University

Status and phase: Completed; Phase 2

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Drug: S1 combined with cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01854749

S1- ESCC -CJH

Details and patient eligibility

About

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

Enrollment: 57 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

S1 combined with cisplatin

Experimental group

Treatment:

Drug: S1 combined with cisplatin