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The Safety and Efficacy of Endostar Combined With Toripalimab as Postoperative Adjuvant Therapy for Resectable Stage III-Oligometastatic Stage IV Cutaneous Melanoma: A Prospective, Single-arm, Open-label, Phase II Clinical Study
The goal of this clinical trial is to evaluate the efficacy and safety of Endostar combined with Toripalimab in the adjuvant treatment of resectable stage III-oligometastatic stage IV melanoma, and to find effective biomarkers of efficacy based on tumor paraffin tissue specimens and peripheral blood. The main questions it aims to answer are: * The efficacy and safety of the combination treatment regimen; * Finding suitable biomarkers can refine the patients with effective treatment After a series of evaluation, if the participants meet the inclusion and exclusion criteria and are evaluated by the investigator, they will formally enter the study observation period and receive the following treatments Endostar: The dose of 210 mg (14 vials) is administered by intravenous pump from Day 1 to Day 3 of each course, every 4 weeks as a cycle, until disease recurrence, metastasis or intolerable toxicity, and up to 6 courses of administration. Toripalimab: 3 mg/kg by intravenous drip every 2 weeks (Day 1 and Day 15 of each cycle) in a 4-week cycle until disease recurrence, metastasis, or intolerable toxicity for up to 1 year (about 13 cycles).
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Fudan University Shanghai Cancer Center
Shanghai, China
Start Date
April 1, 2020
Primary Completion Date
August 1, 2024
Completion Date
August 31, 2024
Last Updated
June 22, 2023
43
ESTIMATED participants
Endostar
DRUG
Toripalimab
DRUG
Lead Sponsor
Fudan University
NCT05039801
NCT06391099
Data Source & Attribution
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