CClinicalTrials.gg
Status unknownNCT02677597Updated Feb 9, 2016

Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma

A Phase 3 interventional study of Cisplatin Combined With S-1 and Cisplatin Combined With Paclitaxel in Esophageal Squamous Cell Carcinoma, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-02-09.

Sponsored by Fudan University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
268
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma

02

Conditions studied

03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 268 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically proven primary thoracic esophageal squamous cell carcinoma
  • Not suitable for surgery or radio or chemical therapy
  • Presence of at least one index lesion measurable by CT scan or MRI radiation therapy ended at least 4 weeks, but part of the radiation does not as a measurable lesions
  • 18\~70 years
  • PS:0-1
  • Life expectancy of ≥ 3 months
  • WBC≥3.5×109/L,ANC≥1.5×109/L, PLT≥100×109/L, Hb≥100g/L
  • TB ≤ 1.5UNL, ALT/AST ≤ 2.5×UNL
  • Scr≥60 mL/min
  • Normal electrocardiogram (ecg)
  • Can normal oral drugs
  • Signed written informed consent

Exclusion criteria

Exclusion Criteria:

  • Breast-feeding or pregnant women, no effective contraception if risk of conception exists
  • Chronic diarrhea, enteritis, intestine obstruction which are not under control
  • Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc.
  • A second primary tumor (except skin basal cell carcinoma)
  • The original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension
  • With uncontrol nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; Primary brain tumors or - CNS metastases illness did not get a control, has obvious cranial hypertension or nerve mental symptoms
  • With bleeding tendency
  • Has inherited bleeding evidence of physical or blood coagulation disorder
  • With clear chemotherapy drug allergy
  • Other researchers believe that patients should not participate in this testing
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
268 participants (estimated)

Study arms

  • Experimental
    Cisplatin Combined With S-1

    Cisplatin 75mg/m2 ivgtt d1 S-1 BSA\<1.5 50mg bid,BSA≥1.5 60mg bid po d1-14

    Drug: Cisplatin Combined With S-1

  • Experimental
    Cisplatin Combined With Paclitaxel

    Cisplatin 75mg/m2 ivgtt d1 Paclitaxel 175mg/m2 d1 ivgtt 3h

    Drug: Cisplatin Combined With Paclitaxel

Interventions

  • DrugCisplatin Combined With S-1
  • DrugCisplatin Combined With Paclitaxel
06

What researchers measure

Primary outcomes

  1. PFS

    Time frame: Since the date of random to disease progression or any cause of death,the average time is 2 years

07

Study locations

1 of 1 sites recruiting
  • Cancer hospital Fudan University
    Shanghai, Shanghai 200032, China
    • Chang J hua, PD · Contact · changjianhua@163.com · 13916619284
    • Chang J hua, PD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02677597
Lead sponsor
Fudan University
Responsible party
Chang Jian Hua (Chief Physician, Fudan University) — Principal investigator
First posted
Feb 9, 2016
Start date
Jan 2016
Primary completion
Jan 2019 (estimated)
Completion
Jan 2019 (estimated)
Last update
Feb 9, 2016

Study contacts

Chang J Hua, PD
Contact
changjianhua@163.com
13916619284

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion