Endostar Combined With MPFC Adjuvant Treatment of Esophageal Cancer Clinical Trial

• Status: Terminated
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Endostar ® (recombinant human endostatin) continuous intravenous infusion combined with mPFC neoadjuvant treatment of esophageal cancer arm, Ⅱ single-center clinical trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Treatments: Cisplatin; Endostar protein; Tegafur

Criteria

Inclusion Criteria:

• patients with esophageal cancer confirmed by histology or cytology;

• according to TNM staging for Ⅲ period, previous untreated can be removed and potentially resectable esophageal cancer patients;

• can eat more than liquid diet;No signs before esophageal perforation;No distant metastasis;

• male or female, age 18 and 75 years old or less or more;

• ECOG PS 0 ~ 1 minute;

• is expected to survive period for 3 months or more,

• enough blood function: absolute neutrophil count (ANC) or 2 x 109 / L and the • platelet count 100 x 109 / L or higher acuity 9 g/dL and hemoglobin;Liver function

• enough: upper limit of total bilirubin acuities were normal (ULN);AST and ALT acuities were 2.5 times the upper limit of normal (ULN);Alkaline phosphatase 5 times the upper limit of normal or less (ULN);

• enough renal function, serum creatinine or less normal limit (ULN) or calculated creatinine clearance or 60 mL/min.

• basic normal ecg, no healing trauma;

• always not received anti-tumor drug treatment;

• ever had had surgery patients, request to study treatment began to have more than 4 weeks, and the patient has recovered;

• a complete uterus of female in the group within 28 days before the study must have a negative pregnancy test results (except amenorrhea has 24 months).If the pregnancy test from the first time for more than 7 days, is the need for urine pregnancy test validation (within 7 days before the first delivery).

• prior to biological agents, especially e. coli genetically engineered products without severe allergic reactions;

Exclusion Criteria:

• there is a clear taxol allergy history;

• pregnancy, nursing mothers, or have fertility but not women using contraception;

• the existing serious acute infection, and not be controlled;Or fester sex and chronic infection, wound in delay no more;

• 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;

• is not easy to control 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 symptoms in cranial hypertension or nerve spirit;

• with bleeding tendency;