Albumin Bound Paclitaxel Plus S-1 as the First Line Chemotherapy in Advanced or Recurrent Gastric Cancer

Study Overview
=================
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.

Official Title
-----------------
Phase II Study of Albumin Bound Paclitaxel Plus S-1 as the First Line Chemotherapy in Advanced or Recurrent Gastric Cancer

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: Albumin Bound Paclitaxel
* Drug: S-1


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Albumin Bound Paclitaxel plus S-1<br>Abraxane 120 mg/m2, D1,D8;S-1 40 60mg QD D1-D14,every 3 weeks until disease progress or intolerable toxicity. | Drug: Albumin Bound Paclitaxel<br>* 120 mg/m2, D1,D8,every 3 weeks until disease progress or intolerable toxicity.<br>* Other names: abraxane;Drug: S-1<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Progression-free survival is determined from the date of treatment to PD or death. | through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | the ratio of patients whose efficiency evaluation is CR or PR | up to one year | 
| Overall survival | the date of treatment to death from any cause or the last follow-up date | OS follow-up period: 18 months or 80% OS events, whichever occurs first. | 
| Disease control rate | the ratio of patients whose efficiency evaluation is CR or PR or SD | AEs (Adverse events) should be recorded during the study period and six months after last IMP administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric Cancer, Albumin Bound Paclitaxel, S-1, First Line