Recurrent, metastatic or unresectable gastric cancer
Conditions
Interventions
Group A:S-1 80mg/m2/d orally taken twice daily D1-21
CDDP 20mg/m2 infusion D1-4
Group B:5-FU 800mg/m2/24h infusion D1-5
Sponsors
Shenzhen Main Luck Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed recurrent, metastatic, or unresectable gastric cancer; 2. Age 18~75, be able to take oral medications; 3. At least one radiographically documented (CT scan or MRI) measurable lesion according to RECIST; 4. No prior palliative chemotherapy or radiotherapy. Prior adjuvant chemotherapy allowed if finished > 6 months before recurrent; 5. ECOG performance status 0-2, Karnofsky >=70; 6. Organs function basically normal: (1) AST/ALT=2,000/ul; (5) Platelets >=100,000/uL; (6) Hemoglobin >=9 g/dL; (7) Serum creatinine =60 mL/min; 7. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Prior concurrent therapy as follows: (1) More than 2 prior adjuvant chemotherapies; (2) CDDP>300mg/m2; (3) Radiation >25% marrow bearing bone; (4) Have received S-1, 5-FU or CDDP within 30 days; (5) Join in other study. 2. Any other conditions according to investigator; 3. Receiving a concomitant treatment with drugs interacting with S-1, 5-FU or CDDP; 4. Hypersensitivity to S-1, 5-FU or CDDP; 5. Pregnant or nursing; 6. Refuse to use an acceptable means of contraception (including male patients).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;TTP; | — |
Countries
China
Contacts
Public ContactZhongZhen Guan, Ruihua Xu
Outcome results
None listed