esophageal carcinoma
Conditions
Interventions
test group:Esophageal dilation + Shenmai intravenous cisplatin sustained release implant in local
Group:Esophageal dilation + shenmai infusion
Sponsors
First Affiliated Hospital, Fourth Military Medical University;First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Males or females who are older than 18 years; 2. Suitable for patients for implantation of the particles: advanced esophageal carcinoma patients failed from radiotherapy and chemotherapy; dysphagia severity score II~III (Stooler) after endoscopic dilatation; 3. Advanced esophageal carcinoma patients failed from radiotherapy and chemotherapy with carcinoma obstruction expandable to 12 mm; Advanced esophageal carcinoma patients failed or intolerance from radiotherapy and chemotherapy with carcinoma obstruction expandable to 15 mm (Second physiological stenosis expandable to12 mm); 4. tumor cells as squamous cell type (Hl); 5. the length of esophageal tumor site =8cm; 6. The expected survival time is greater than or equal to 3 months; 7. Life quality score (Karnofsky score)=60; 8. Blood tests: (1) PLT =80×10^9/L; (2) Coagulation function PT is not more than 2s; 9. Women of childbearing age must be a pregnancy test in 7 days before entering the group (serum), and results should be negative, and they are willing with contraception during the experiment till 8 weeks after the last administration. For males, they are willing with contraception till 8 weeks after the last administration; 10. Patients voluntarily entered into the group, and signed a written informed consent, good compliance, with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with localized esophageal obstruction due to non-tumor progression; 2. Having a bleeding tendency or being treated with thrombolytic or anticoagulant therapy; 3. Less than 4 weeks from chemotherapy or palliative radiotherapy (dosage is less than or equal to radical radiation or radical radiation within 12 months; 4. Serious active infection, need to be hospitalized; 5. Serious mental or neurological diseases require medication; 6. With other malignant tumors (other than esophageal cancer), except cured skin basal cell carcinoma and cervical carcinoma in situ; 7. Known to have a history of allergy to the drug; 8. Immunodeficiency diseases (HIV test positive, syphilis positive, HBSAg positive, HBeAg positive, Core antibody positive in Hepatitis B five tests); 9. Participated other clinical drug trails within 4 weeks; 10. Pregnant or lactating women; 11. Men or women who are not willing for contraception during the clinical trials; 12. According to the investigator's judgment, patients with serious harm or influence of the accompanying disease (such as severe diabetes, etc.) to the safety and to complete the study; 13. A drug or a history of drug abuse; 14. With contraindication of endoscopic examination and treatment; 15. Clinical evidence of dysfunction for heart, lung, liver and renal function; 16. The investigators determine that the patient had other symptoms or events that were not appropriate for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival;Swallowing difficulty control; | — |
Countries
China
Contacts
Public ContactZhang Hongbo; Luo Qi; Wang Xin; Ye Feng
First Affiliated Hospital, Fourth Military Medical University; First Affiliated Hospital of Xiamen University
Outcome results
None listed