Clinical trial · Interventional
Rh-endostatin in Combination With Dacarbazine and Cisplatin as the First Line Therapy for Metastatic Melanoma
a Phase II Trial With Continuous Intravenous Infusion of Rh-endostatin in Combination With Dacarbazine and Cisplatin as the First Line Therapy for Metastatic Melanoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant human endostatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EDP
- description
- Dacarbazine,DTIC： 250 mg/m2/d，IV, d1-5 Cisplatin PDD：75 mg/m2，IV Endostar ENDO：15 mg/m2/d，CIV,d1\~14
- interventionNames
- Drug: recombinant human endostatin
Primary outcomes (1)
- measure
- progress-free survival(PFS)
- timeFrame
- From randomization up to 144 weeks
- description
- Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause
Secondary outcomes (2)
- measure
- Disease control rate(DCR)
- timeFrame
- From randomization up to 144 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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 * 4\. 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 * 2\. Acute infections without control. * 3\. Heart disease history, cardiac function class≥NYHA II. * 4\. HIV positive or chronic HBV/HCV in active stage. * 5\. Brain metastases or primary tumor with positive symptoms * 6\. Need anti-epileptic treatments * 7\. Organ transplantation history * 8\. Hemorrhagic tendency or related history * 9\. Renal dialysis patients * 10\. Diagnosis of any second malignancy within the last 3 years, except for adequately treated. * 11\. Current treatment on another clinical trial * 12\. The other improper situations which investigator judged.
References
Publications (1)
- RESULTCui C, Mao L, Chi Z, Si L, Sheng X, Kong Y, Li S, Lian B, Gu K, Tao M, Song X, Lin T, Ren X, Qin S, Guo J. A phase II, randomized, double-blind, placebo-controlled multicenter trial of Endostar in patients with metastatic melanoma. Mol Ther. 2013 Jul;21(7):1456-63. doi: 10.1038/mt.2013.79. Epub 2013 May 14. PMID 23670576