Advanced melanoma
Conditions
Interventions
Control group:Dacarbazine combined with placebo
Experimental group:Endostar combined with dacarbazine (add a drug that inhibits neovascularization to chemotherapy)
Sponsors
Expert Committee for Melanoma of CSCO
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age > 18 years old, males or females; 1. Untreated patients with advanced melanoma confirmed by histopathology or cytology; 2. With tumor foci that can be evaluated by CT or MRI; at least one diameter >=1 cm (including metastatic lymph nodes, diameter >1 cm confirmed by CT scan); or superficial focus >=2 cm (confirmed by photos with calibration); 3. No contraindication for chemotherapy, with normal peripheral hemogram, renal and hepatic function:Peripheral hemogram: WBC>=4.0*10^9/L, PLT>=80*109/L, Hgb>=90g/L; Renal function: serum BUN and creatinine =70 (appendix 1); expected survival time>=3 months; 5. Patients are voluntary to participate and sign the informed contents.
Exclusion criteria
Exclusion criteria: 1. Pregnance women, woman did not takes contraception method; 2. With severe acute infection uncontrolled; purulent or chronic infection with wounds difficult to recover; 3. With history of severe heart diseases, including congestive heart failure, uncontrolled arrhythmia with high risk, unstable angina pectoris, myocardial infarction, severe cardiac valvular diseases and refractory hypertension; 4. Have been treated by dacarbazine or dacarbazine included combination chemotherapy; 5. Patients with uncontrolled neurological, mental disease or psychosis, patients with poor compliance that cannot coordinate the therapy or describe the treatment response; 6. Uncontrolled brain metastasis patients with obvious manifestations of intracranial hypertension or neurological and mental disorders; 7. Allergic to any drug in the trial; 8. Patients with a second tumor; 9. Patients participating in other clinical trials; 10. Other conditions that are regarded for exclusion by the trialists.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival time;Total survival tim; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor response rate;Disease controlled rate and adverse effect; | — |
Countries
China
Contacts
Public ContactJun Guo
Outcome results
None listed