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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Esophageal Squamous Cell Carcinoma

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

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

Safety Issue:

No

Authority:

China: Ethics Committee

Study ID:

S1- ESCC -CJH

NCT ID:

NCT01854749

Start Date:

November 2011

Completion Date:

Related Keywords:

  • Esophageal Squamous Cell Carcinoma
  • ESCC
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Neoplasm Metastasis
  • Recurrence

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