Acral Melanoma Clinical Trial
Official title:
Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma: a Multicenter, Prospective, Randomized Controlled Trial
It is a RCT aimed to evaluate the Progression Free Survival of Camrelizumab combined with apatinib and temozolomide as First Line Therapy in Advanced Acral Melanoma.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | February 15, 2027 |
Est. primary completion date | August 15, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age:=18 years, male or female. - Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV). - Has not received any systematic anti-tumor drug treatment. - Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. - ECOG 0-1. - Adequate organ function. - Life expectancy of greater than 12 weeks. - Patient has given written informed consent. Exclusion Criteria: - Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy. - Known history of hypersensitivity to macromolecular protein preparation or any components of the drug formulation. - Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ); - Subjects with any active autoimmune disease or history of autoimmune disease Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention; - Received a live vaccine within 4 weeks before the first dose of study medication. - Pregnancy or breast feeding. - Decision of unsuitableness by principal investigator or physician-in charge. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Cancer Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University Cancer Hospital & Institute |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival, PFS | PFS was defined as the time from randomization to progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. | Within 2 years | |
Secondary | Overall Survival ,OS | OS will be defined as the time from randomization to death due to any cause. | Within 2 years | |
Secondary | ORR | The objective response rate will be assessed by RECIST 1.1 | Within 2 years | |
Secondary | DCR | The disease control rate will be assessed by RECIST 1.1 | Within 2 years | |
Secondary | Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. | Within 2 years |
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