Status:
RECRUITING
Camrelizumab Plus Apatinib and Temozolomide as Neoadjuvant in High Risk Acral Melanoma
Lead Sponsor:
Peking University Cancer Hospital & Institute
Conditions:
Melanoma
Acral Melanoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Neoadjuvant therapy is feasible in stage Ⅱ-Ⅲ melanoma, Carrelizumab combined with apatinib and temozolomide has synergistic antitumor effects and may improve pathological response.
Detailed Description
Patients with resectable melanoma can benefit from neoadjuvant therapy, including improved surgical outcomes, precise management of patients based on neoadjuvant response, and analysis of resistance m...
Eligibility Criteria
Inclusion Criteria:
- age:18-75 years, male or female.
- Histopathologically confirmed acral melanoma (stage Ⅱ/Ⅲ).
- 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 any component of apatinib, temozolomide, Camrelizumab.
- 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
- Patients with any unstable systemic disease, including but not limited to: serious infection, uncontrolled diabetes, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, myocardial infarction, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease;
- Received a live vaccine within 4 weeks of the first dose of study medication.
- Pregnancy or breast feeding.
- Decision of unsuitableness by principal investigator or physician-in charge.
Key Trial Info
Start Date :
September 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05512481
Start Date
September 13 2022
End Date
December 31 2026
Last Update
March 3 2025
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China