Clinical trial · Interventional
Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
An Open, Multicenter, Randomized Phase III Clinical Study on Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
NCT02677597CI-TRIAL-00020838unknownPhase 3ClinicalTrials.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)
Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin Combined With Paclitaxel | Drug | — | UNRESOLVED |
| Cisplatin Combined With S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cisplatin Combined With S-1
- description
- Cisplatin 75mg/m2 ivgtt d1 S-1 BSA\<1.5 50mg bid,BSA≥1.5 60mg bid po d1-14
- interventionNames
- Drug: Cisplatin Combined With S-1
- type
- EXPERIMENTAL
- label
- Cisplatin Combined With Paclitaxel
- description
- Cisplatin 75mg/m2 ivgtt d1 Paclitaxel 175mg/m2 d1 ivgtt 3h
- interventionNames
- Drug: Cisplatin Combined With Paclitaxel
Primary outcomes (1)
- measure
- PFS
- timeFrame
- Since the date of random to disease progression or any cause of death,the average time is 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven primary thoracic esophageal squamous cell carcinoma * Not suitable for surgery or radio or chemical therapy * Presence of at least one index lesion measurable by CT scan or MRI radiation therapy ended at least 4 weeks, but part of the radiation does not as a measurable lesions * 18\~70 years * PS:0-1 * Life expectancy of ≥ 3 months * WBC≥3.5×109/L,ANC≥1.5×109/L, PLT≥100×109/L, Hb≥100g/L * TB ≤ 1.5UNL, ALT/AST ≤ 2.5×UNL * Scr≥60 mL/min * Normal electrocardiogram (ecg) * Can normal oral drugs * Signed written informed consent Exclusion Criteria: * Breast-feeding or pregnant women, no effective contraception if risk of conception exists * Chronic diarrhea, enteritis, intestine obstruction which are not under control * Esophageal obstruction cannot eat liquid completely, esophagus have deep ulcer perforation or hematemesis; Esophageal cancer common complications such as anastomotic leakage, serious lung complications, etc. * A second primary tumor (except skin basal cell carcinoma) * The original serious heart disease, including: higher risk of congestive heart failure, unable to control arrhythmia, unstable angina, myocardial infarction, severe valvular heart disease, and resistant hypertension * With uncontrol nerve, mental illness or mental disorders, compliance is poor, can't cooperate with accounts and response to treatment; Primary brain tumors or - CNS metastases illness did not get a control, has obvious cranial hypertension or nerve mental symptoms * With bleeding tendency * Has inherited bleeding evidence of physical or blood coagulation disorder * With clear chemotherapy drug allergy * Other researchers believe that patients should not participate in this testing
References
Publications (0)
Data not yet available
No reference posted for this study.