Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma

• Status: Unknown status
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Cisplatin Combined With S-1 or Paclitaxel as First-line Treatment for Metastatic Esophageal Squamous Cell Carcinoma

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

Criteria

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