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CompletedNCT01854749Updated Feb 23, 2016

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

A Phase 2 interventional study of S1 combined with cisplatin in Esophageal Squamous Cell Carcinoma, sponsored by Fudan University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-02-23.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
57
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Esophageal Squamous Cell Carcinoma

Keywords

  • ESCC
03

In context

Esophageal Squamous Cell Carcinoma

657 studies on the registry are indexed under Esophageal Squamous Cell Carcinoma; 276 are open to participants now.

This study's enrollment of 57 is below the median of 64 across 550 interventional studies indexed under Esophageal Squamous Cell Carcinoma.

Browse Esophageal Squamous Cell Carcinoma studies →

Lead sponsor

Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.

Browse Fudan University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
57 participants (actual)

Study arms

  • Experimental
    S1 combined with cisplatin

    Drug: S1 combined with cisplatin

Interventions

  • DrugS1 combined with cisplatin
06

What researchers measure

Primary outcomes

  1. Progression Free Survival

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

07

Study locations

1 site
  • Cancer hospital Fudan University
    Shanghai, Shanghai Municipality 200032, China
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2011 and a primary completion of Dec 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2013
First posted
May 16, 2013
Start
Nov 2011
Primary completionActual
Dec 2015
Last update
Feb 23, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01854749
Lead sponsor
Fudan University
Responsible party
Chang Jian Hua (Deputy director of medical oncology, Fudan University) — Principal investigator
First posted
May 16, 2013
Start date
Nov 2011
Primary completion
Dec 2015
Last update
Feb 23, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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