Rh-endostatin in Combination With Dacarbazine and Cisplatin as the First Line Therapy for Metastatic Melanoma

Peking University Cancer Hospital & Institute

Status and phase

Unknown

Phase 2

Conditions

Melanoma

Treatments

Drug: recombinant human endostatin

Study type

Interventional

Funder types

Other

Identifiers

NCT03095079

BCH-MM-

Details and patient eligibility

About

The incidence of Melanoma is rapidly growthing,and in China,dacarbazine combined with cisplatin is conmendly used as the first-line chemotherapy of metastatic melanoma. But the response rate and survival results are very limited.This trial aim to add a safe and effective anti-angiogenesis drug,Human-recombinant endostatin,to find out a new strategy which may further extend the PFS and OS with a tolerated toxicity.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Histologically confirmed melanoma with metastases and has no received any systemic treatment.
2.At least one measurable site (diameter≥1cm) of disease (RECIST 1.1).
3.Estimated life expectancy of 12 weeks or greater
1. ECOG performance status 0, 1
5.Adequate organ function
6.Without symptoms of brain metastases and stable in neuro-functions

Exclusion criteria

1. Pregnant or lactation women
1. Acute infections without control.
1. Heart disease history, cardiac function class≥NYHA II.
1. HIV positive or chronic HBV/HCV in active stage.
1. Brain metastases or primary tumor with positive symptoms
1. Need anti-epileptic treatments
1. Organ transplantation history
1. Hemorrhagic tendency or related history
1. Renal dialysis patients
1. Diagnosis of any second malignancy within the last 3 years, except for adequately treated.
1. Current treatment on another clinical trial
1. The other improper situations which investigator judged.