Clinical trial · Interventional
Docetaxel and S-1 Combination Therapy as Second-line Treatment for Advanced Gastric Cancer
A Single-arm Phase II Trial of Biweekly Docetaxel and S-1 Combination Therapy as Second-line Treatment for Advanced Gastric Cancer
NCT03137004CI-TRIAL-00027413unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- biweekly DS
- description
- The biweekly DS regimen consisted of Docetaxel (50mg/m2) and S-1 (40mg/m2)
- interventionNames
- Drug: Docetaxel
- Drug: S-1
Primary outcomes (1)
- measure
- six-month overall survival
- timeFrame
- 6 months
Secondary outcomes (4)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 6 months
- measure
- Overall Survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.