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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Envafolimab: 300mg day1, s.c. Q3W; Recombinant human endostatin: 210mg day1, Intravenous pump for 72 hours, Q3W; Temozolomide: 150 mg/m2 d1-5, i.v. Q3W; Cisplatin: 25 mg/m2 d1-3, i.v. Q3W. All of the above drugs were used for 6 cycles, and then Envafolimab and recombinant human endostatin continued only in patients with no progression in the first stage until disease progression as defined by RECIST1.1, unacceptable toxicity, withdrawal from the study or death, or no more than 2 years.
Progression-free Survival (PFS)
Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.
Time frame: 12 months
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with measurable lesions achieving a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) criteria.
Time frame: 12 months
Disease Control Rate (DCR)
The proportion of participants who achieves a best overall response of CR, PR or stable disease(SD).
Time frame: 12 months
Duration of Response (DoR)
The time from the date that response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever occurs first.
Time frame: 12 months
Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause.
Time frame: 12 months
PD-L1 expression from the tissue and peripheral blood samples of the patients
The tissue and peripheral blood samples of the patients were taken for the determination of PD-L1 expression, and the results were analyzed to find the predictive factors of prognosis or curative effect.
Time frame: baseline (When entering the group)
ctDNA expression from the tissue and peripheral blood samples of the patients
The tissue and peripheral blood samples of the patients were taken for the determination of ctDNA expression, and the results were analyzed to find the predictive factors of prognosis or curative effect.
Time frame: baseline (When entering the group)
Adverse Events (AEs) according to CTCAE v5.0.
Adverse Events (AEs) according to CTCAE v5.0.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.