Clinical trial · Interventional
Study Comparing Sequential Therapy of S1+Docetaxel Followed by S1 to Concomitant S1+Docetaxel for Advanced Gastric Cancer
NCT01718626CI-TRIAL-00008431unknownPhase 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)
Stage 1:First line therapy Sequential therapy of S1+Docetaxel followed by S1 is superior to concomitant S1+Docetaxel in the safety and clinical efficiency. Stage 2:Second line therapy To explore the feasibility of single drug(S1) maintenance treatment for advanced gastric cancer.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S1+Docetaxel | Drug | — | UNRESOLVED |
| S1+Docetaxel followed by S1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- S1+Docetaxel
- interventionNames
- Drug: S1+Docetaxel
- type
- EXPERIMENTAL
- label
- S1+Docetaxel followed by S1
- interventionNames
- Drug: S1+Docetaxel followed by S1
Primary outcomes (1)
- measure
- Progression-free survival(PFS)
- timeFrame
- 1 years
Secondary outcomes (3)
- measure
- Objective response rate(ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent form * Performance Status-Eastern Cooperative Oncology Group (ECOG) 0-1 * Histologically or cytologically confirmed gastric cancer * Advanced or recurrent, metastatic disease * At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors ) * Life expectancy of at least 3 months * Target target lesion has not received radiotherapy or non target lesion radiation at least 4 weeks * Haematopoietic and Hepatic status: Absolute neutrophil count \>1.5x109/L,Platelet count \> 100 x 109/L,Hemoglobin at least 9 g/dl,Bilirubin ≤ 1.5 x upper limit of normal (ULN),AST and ALT ≤ 2.5 times ULN(no liver metastasis), ≤5 times ULN(with liver metastasis) * Cardiovascular: Baseline LVEF 50% measured by echocardiography Exclusion Criteria: * Symptomatic brain metastasis * Active or uncontrolled infection * Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2; peripheral neuropathy of grade 2 or greater Symptomatic brain metastasis * Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, uncontrolled hypertension (≥ 180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen * History of other malignancy * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.