Recruiting NCT05789043
Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: camrelizumab+apatinib+TMZ, camrelizumab+apatinib, camrelizumab.
- Who it may be relevant to
- Registry conditions: Acral Melanoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma: a Multicenter, Prospective, Randomized Controlled Trial
Overview
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.
Interventions
- Drug camrelizumab+apatinib+TMZ
camrelizumab 200mg，q2w+apatinib 250mg，qd+TMZ 200mg/m2，day1-5/28 - Drug camrelizumab+apatinib
camrelizumab 200mg，q2w+apatinib 250mg qd - Drug camrelizumab
camrelizumab 200mg，q2w
Primary outcome measures
- Progression Free Survival, PFS [Time frame: Within 2 years]
Secondary outcome measures (4)
- Overall Survival ,OS [Time frame: Within 2 years]
- ORR [Time frame: Within 2 years]
- DCR [Time frame: Within 2 years]
- Adverse Events (AEs) [Time frame: Within 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Cancer Hospital — Beijing
Identifiers
NCT: NCT05789043 · MA-MM-III-004