Gastric Cancer
Conditions
Keywords
Gastric Cancer, Albumin Bound Paclitaxel, S-1, First Line
Brief summary
The purpose of this study is to evaluate the effectiveness and safety of s-1 plus Albumin Bound Paclitaxel as first-line therapy in the treatment of patients with advanced gastric cancer.
Detailed description
As the first phase II clinical trial of fluoropyrimidines plus Nab-PTX in AGC patientsphase II trial, this study aimed to evaluate the efficacy and safety of S-1 plus Nab-PTX as a first-line treatment for patients with metastatic gastric cancer. All patients were orally treated with S-1 in doses of 40 mg (BSA\<1.25 m2), 50 mg (1.25≤BSA\<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-14 in combination with Nab-PTX (240 mg/m2, divided on days 1 and 8, intravenously for 30 minutes) of each 21-day cycle. Treatment was planned for 6 cycles or until progression, unacceptable toxicity, or patient refusal.
Interventions
120 mg/m2, D1,D8,every 3 weeks until disease progress or intolerable toxicity.
DRUGS-1
40mg QD D1-D14,every 3 weeks,for BSA\<1.25 m2, 50mg QD D1-D14,every 3 weeks,for BSA=1.25～1.5m2, 60mg QD D1-D14,every 3 weeks,for BSA\>1.5m2,until disease progress or intolerable toxicity.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed adenocarcinoma of the stomach with inoperable locally advanced or recurrent and/or metastatic disease. * Male or female. * Age ≥ 18. * No previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study). * Measurable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST) * ECOG Performance status 0, 1 or 2 * Haematological, Biochemical and Organ Function: Neutrophil count \>2.0 × 10 9/L, platelet count \> 100 ×10 9/L. Serum bilirubin\< 1.5 × upper limit of normal (ULN); or, AST or ALT \< 2.5 × ULN (or \< 5 × ULN in patients with liver metastases); or, alkaline phosphatase\< 2.5 × ULN (or \> 5 × ULN in patients with liver metastases,Creatinine clearance \> 60 mL/min. * Signed informed consent.
Exclusion criteria
* Prior palliative chemotherapy. * Received any investigational drug treatment within 30 days of start of study treatment. * Patients with active gastrointestinal bleeding. * Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma. * History or clinical evidence of brain metastases. * Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes. * Pregnancy women. * Subjects with reproductive potential not willing to use an effective method of contraception. * Patients with known active infection with HIV. * Known hypersensitivity to any of the study drugs. * Neurological toxicity ≥ grade 2 NCI-CTCAE.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | through study completion, an average of 2 years | Progression-free survival is determined from the date of treatment to PD or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | up to one year | the ratio of patients whose efficiency evaluation is CR or PR |
| Overall survival | OS follow-up period: 18 months or 80% OS events, whichever occurs first. | the date of treatment to death from any cause or the last follow-up date |
| Disease control rate | AEs (Adverse events) should be recorded during the study period and six months after last IMP administration | the ratio of patients whose efficiency evaluation is CR or PR or SD |
Countries
China
Outcome results
None listed