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

• Status: Unknown status
• Trial end date: 2018-10-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Cancer Hospital
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

1. Age: 18-75 years old;

2. Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;

3. 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.

4. Relapse within 6 months after adjuvant chemotherapy;

5. ECOG (Eastern Cooperative Oncology Group)performance status 0-2;

6. At least 1 measurable lesion should be present（RECIST1.1）

7. 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

8. Signed informed consent.

9. Life expectancy ≥3 months;

Exclusion Criteria:

1. Previous treatment with taxanes (not including intraperitoneal use of taxanes);

2. Known history of hypersensitivity to study drugs;

3. Active CNS metastases not controllable with radiotherapy or corticosteroids;

4. Pregnant or breast feeding women;

5. Severe co-morbid illness and/or active infections;

6. Active and uncontrollable bleeding from gastrointestinal tract

7. Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or allopurinol;

8. Other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix);

9. Known HIV infecton.