Sorafenib as a Second Line Treatment in Patients With Advanced or Metastatic Gastric Cancer
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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).
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
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ECOG performance scale ≤ 2
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At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
5 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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