Envafolimab Combined With Recombinant Human Endostatin and First-line Chemotherapy Treat of Advanced Mucosal Melanoma

Summary

This is a phase II, open, single-center study to explore the efficacy and safety of Envafolimab combined with recombinant human endostatin, temozolomide and cisplatin in the treatment of mucosal melanin. At the same time, the tissue and peripheral blood samples of the patients were taken for the determination of PD-L1 expression, ctDNA and other biomarkers and the results were analyzed to find the predictive factors of prognosis or curative effect. Patients with advanced mucosal melanoma who met the inclusion criteria but did not meet the exclusion criteria were enrolled in this study and received 6 cycles of Envafolimab combined with recombinant human endostatin, temozolomide and cisplatin. Patients without progression were then maintained with Envafolimab combined with recombinant human endostatin until disease progression, intolerable adverse reactions, patient death or withdrawal of informed consent. The longest administration time of recombinant human endostatin was no more than 1 year, and that of Envafolimab was not more than 2 years. The efficacy was evaluated for the first time at 6 weeks, every 6 weeks for the following year, and then every 12 weeks until the end of progress or treatment. The examination method was consistent with the baseline; it was expected to be included in the group for 18 months, and clinical observation until disease progression and patient death.

Timeline

Start

2023-09-18

Primary completion

2025-09-18

Completion

2026-03-18

Drugs

Indications