Docetaxel and S-1 Combination Therapy as Second-line Treatment for Advanced Gastric Cancer

Study Overview
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Brief Summary
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A single-arm phase II study to evaluate the efficacy and safety of docetaxel plus S-1 (DS) as second-line treatment in patients with AGC.

Detailed Description
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For patients with advanced gastric cancer, combination chemotherapy has been shown to improve the quality of life and overall survival (OS) compared with best supportive care alone. Docetaxel is an active agent for treating patients with gastric cancer. S-1, an oral 5-FU prodrug, is active against AGC as a single agent or in combination with cisplatin in phase III trials. Therefore, a single-arm phase II study was conducted to investigate the efficacy and safety of biweekly docetaxel and S-1 (DS) combination therapy as second-line treatment in patients with previously treated advanced gastric cancer.

Official Title
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A Single-arm Phase II Trial of Biweekly Docetaxel and S-1 Combination Therapy as Second-line Treatment for Advanced Gastric Cancer

Conditions
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Advanced Gastric Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: S-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-75 years old; Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma; The patient has experienced disease progression during treatment or within 4 months after the last dose of first-line therapy without taxanes for metastatic disease. Relapse within 6 months after adjuvant chemotherapy; ECOG (Eastern Cooperative Oncology Group)performance status 0-2; At least 1 measurable lesion should be present（RECIST1.1） Available Organ function: Neutrophils>2g/L, Hemoglobin>9g/L, Blood platelet >100g/L; Alanine aminotransferase(ALT） and Aspartate aminotransferase(AST)<1.5 ULN(upper limit of normal); Total bilirubin(TBIL)<1.0 ULN; Cr <1.0ULN Signed informed consent. Life expectancy ≥3 months; Exclusion Criteria: Previous treatment with taxanes (not including intraperitoneal use of taxanes); Known history of hypersensitivity to study drugs; Active CNS metastases not controllable with radiotherapy or corticosteroids; Pregnant or breast feeding women; Severe co-morbid illness and/or active infections; Active and uncontrollable bleeding from gastrointestinal tract Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or allopurinol; Other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix); Known HIV infecton.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: biweekly DS<br>The biweekly DS regimen consisted of Docetaxel (50mg/m2) and S-1 (40mg/m2) | Drug: Docetaxel<br>* Docetaxel 50mg/m2 in 60 min on day 1 and repeated every 14 days.<br>* Other names: Taxotere;Drug: S-1<br>* S-1 was administered orally at 40 mg/m2 twice daily on days 1-7 of each cycle. Patients with a body surface area of less than 1.25 m2 received 80 mg S-1 daily, those with a body surface area of 1.25 m2 or more but less than 1.5 m2 received 100 mg S-1 daily, and those with a body surface area of 1.5 m2 or more received 120 mg S-1 daily.<br>* Other names: TS-1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| six-month overall survival |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) |  | 6 months | 
| Overall Survival (OS) |  | 12 months | 
| Progression-Free Survival (PFS) |  | 12 months | 
| Adverse Event（AE） |  | NCI CTC 4.03 |