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Phase II Trial of Sorafenib as Second Line Therapy in Patients With Advanced or Metastatic Gastric Cancer

Phase 2
18 Years
70 Years
Not Enrolling
Gastric Cancer

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Trial Information

Phase II Trial of Sorafenib as Second Line Therapy in Patients With Advanced or Metastatic Gastric Cancer

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.

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:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

time to progression

Outcome Time Frame:

every six weeks

Safety Issue:


Principal Investigator

Jin Li, PhD, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Ethics Committee

Study ID:




Start Date:

July 2007

Completion Date:

January 2009

Related Keywords:

  • Gastric Cancer
  • Time to Progression
  • Toxicity
  • Overall survival
  • Response rate
  • Quality of live
  • Toxicities
  • Stomach Neoplasms