ClinicalTrials.gg
TerminatedNCT00595985Updated Jul 7, 2009

Sorafenib as a Second Line Treatment in Patients With Advanced or Metastatic Gastric Cancer

A Phase 2 interventional study of sorafenib in Gastric Cancer, sponsored by Fudan University. Terminated at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-07-07.

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

Why this study was terminated
low response rate, no evidence of PFS or OS improved.
Phase
Phase 2
Study type
Interventional
Enrollment
5
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy and tolerability of sorafenib as second line treatment in patients with Advanced or Metastatic Gastric Cancer (A/MGC).

Read the detailed description

Up to now, although FU based, cisplatin based and taxane based regimen, and ECF regimen have been suggested as the first line therapy for A/MGC by FDA, there is no standard regimen for patients with A/MGC as second line treatment. Based on the promising results of sorafenib in primary hepatic carcinoma and renal cancer, we design this clinical trial to evaluate the efficacy, time to progression and overall survival of sorafenib for A/MGC patients as a second line treatment.

02

Conditions studied

  • Gastric Cancer

Browse trials for

Keywords

  • Time to Progression
  • Toxicity
  • Overall survival
  • Response rate
  • Quality of live
  • Toxicities
03

In context

Stomach Neoplasms

2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.

This study's enrollment of 5 is below the median of 66 across 2,143 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Fudan University is the lead sponsor of 1,308 studies on the registry; 637 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

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

  • Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
  • ECOG performance scale ≤ 2
  • At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
  • Adequate hepatic, renal, heart, and hematologic functions:

    • platelets>80 × 109/L
    • neutrophil>2.0 × 109/L
    • serum creatinine ≤ 1.5mg/dl
    • total bilirubin within upper limit of normal(ULN)
    • serum transaminase ≤ 2.5 × the ULN

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating women
  • Concurrent cancer
  • History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
  • Neuropathy, brain, or leptomeningeal involvement
  • Uncontrolled significant comorbid conditions and previous radiotherapy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    A

    administer sorafenib 400mg bid until disease progression or intolerable toxicity or patients withdrawal of consent

    Drug: sorafenib

Interventions

  • sorafenib 400mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

    Also known as: treatment group

06

What researchers measure

Primary outcomes

  1. time to progression

    Time frame: every six weeks

Secondary outcomes

  1. toxicity

    Time frame: 6 weeks

07

Study locations

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

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00595985
Lead sponsor
Fudan University
First posted
Jan 16, 2008
Start date
Jul 2007
Primary completion
Jan 2009 (estimated)
Completion
Jan 2009 (estimated)
Last update
Jul 7, 2009

Study contacts

Jin Li, PhD, M.D.
principal investigator · Fudan University

Oversight

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

Not currently enrolling

This study is terminated, as verified in Jul 2009. 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.

Studies of the drug tested here: Sorafenib

Start the discussion