Phase 2 Study of Camrelizumab, Apatinib, and Temozolomide as Pre-Surgery Treatment for High-Risk Stage III and IIBIIC Acral Melanoma

What this Trial Is About

Researchers are evaluating the use of neoadjuvant therapy in patients with stage III and IIB, IIC high-risk acral melanoma. This study focuses on combining Camrelizumab with Apatinib and Temozolomide to explore their potential synergistic antitumor effects and to improve the pathological response rate. Previous studies at this site showed promising clinical response and safety for this combination in unresectable acral melanoma, and this trial aims to assess its benefits in resectable cases. Participants will receive two cycles of neoadjuvant therapy combining Camrelizumab, Apatinib, and Temozolomide before undergoing surgery to remove melanoma. After surgery, patients will continue with adjuvant treatment of Camrelizumab every three weeks for one year. This design allows researchers to study both short-term and long-term effects of this treatment approach. Throughout the study, participants will be monitored for pathological response at weeks 8 to 12 as the primary outcome. Secondary outcomes include objective response rate within six months, recurrence-free survival at one and two years, overall survival up to ten years, safety and tolerability of treatments and surgery, and patient-reported quality of life. The trial spans treatment, surgery, and follow-up periods to gather comprehensive data on efficacy and safety.

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