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OpenTrials
Completed

NCT Number: NCT01854749

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

S1 combined with cisplatin

Drug

Primary outcomes

  1. Progression Free Survival

    Time frame: from the first cycle of treatment (day one) to two month after the last cycle

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
First posted
May 16, 2013
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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