Clinical trial · Interventional
S1 Combined With Cisplatin in Treatment of Recurrence/Metastasis of ESCC Open-label Single Center Phase II Clinical Study
NCT01854749CI-TRIAL-00021044completedPhase 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)
Assess the efficacy and safety of S1 combined with cisplatin in treatment of recurrence/metastasis of ESCC
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 |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S1 combined with cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- S1 combined with cisplatin
- interventionNames
- Drug: S1 combined with cisplatin
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- from the first cycle of treatment (day one) to two month after the last cycle
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria * Joined the study voluntarily and signed informed consent form; * Age 18-75 .Presence of at least one index lesion measurable by CT scan or MRI * recurrence/metastasis of Esophageal carcinoma or gastroesophageal cancer confirmed by pathology * No radiotherapy, chemotherapy or other treatments prior to enrollment * PS ECOG 0-1 * Life expectancy of more than 3 months * ANC≥2×109/L，PLT≥100×109/L，Hb≥90g/L * Cr≤1.0×UNL * TBIL≤1.25×UNL； ALT/AST≤2.5×UNL，with hepatic metastases ALT/AST≤5.0×UNL；AKP≤2.5×UNL Exclusion Criteria: * there is radical cure of the cancer * uncontrolled chronic diarrhea and esophageal obstruction * Neurological or mental abnormalities Influence of cognitive ability include central nervous system metastases * Severe complication(s), e.g.,uncontrolled active infection,myocardial infarction,hypertension,arrhythmia,stenocardia * Patient who has metastasis except cured skin basal cell carcinoma and carcinoma in situ of cervix * accept other antitumor therapy •Female patients during their pregnant and lactation period, or patients without contraception
References
Publications (0)
Data not yet available
No reference posted for this study.