Camrelizumab Plus Apatinib and Temozolomide as Neoadjuvant in High Risk Acral Melanoma

Launched by PEKING UNIVERSITY CANCER HOSPITAL & INSTITUTE · Aug 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a combination of three medications—Camrelizumab, Apatinib, and Temozolomide—to see how effective they are as a treatment before surgery for patients with high-risk acral melanoma, which is a type of skin cancer. The goal is to find out if this combination can help shrink the tumors and improve the chances of a better outcome after surgery. The trial is currently looking for participants aged 18 to 75 who have been diagnosed with stage II or III acral melanoma and have not received any prior cancer treatment.

If you or a loved one is considering joining this trial, you should know that participants will receive these medications for a period of time before undergoing surgery. To be eligible, participants need to be generally healthy, have measurable tumors, and be able to provide informed consent. However, individuals with certain health issues or those who are pregnant or breastfeeding cannot participate. This trial is an important step in exploring new treatment options for this challenging type of melanoma, potentially offering hope for better results.

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Eligibility criteria

• Inclusion Criteria:
• • 1. age:18-75 years, male or female.
• • 2. Histopathologically confirmed acral melanoma (stage Ⅱ/Ⅲ).
• • 3. Has not received any systematic anti-tumor drug treatment.
• • 4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
• • 5. ECOG 0-1.
• • 6. Adequate organ function.
• • 7. Life expectancy of greater than 12 weeks.
• • 8. Patient has given written informed consent.
• Exclusion Criteria:
• • 1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
• • 2. Known history of hypersensitivity to any component of apatinib, temozolomide, Camrelizumab.
• • 3. Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
• • 4. Subjects with any active autoimmune disease or history of autoimmune disease
• • 5. 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;
• • 6. Received a live vaccine within 4 weeks of the first dose of study medication.
• • 7. Pregnancy or breast feeding.
• • 8. Decision of unsuitableness by principal investigator or physician-in charge.