Camrelizumab, apatinib and temozolomide before surgery for high-risk acral melanoma
Tests camrelizumab, apatinib and temozolomide before surgery in adults with acral melanoma.
Plain-language title generated from the registry record
Registry title: Camrelizumab Plus Apatinib and Temozolomide as Neoadjuvant in High Risk Acral Melanoma
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05512481, who can take part
Where in China
- Beijing Cancer HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking University Cancer Hospital & Institute
- Trial code
- NCT05512481
- Record updated
- 3 March 2025
- Original description
Neoadjuvant therapy is feasible in stage Ⅱ-Ⅲ melanoma, Carrelizumab combined with apatinib and temozolomide has synergistic antitumor effects and may improve pathological response.Read full original descriptionShow less
A Phase 2 Clinical Trial of Neoadjuvant Camrelizumab Plus Apatinib and Temozolomide in High Risk Clinical Stage Ⅱ-Ⅲ Acral Melanoma
Neoadjuvant therapy is feasible in stage Ⅱ-Ⅲ melanoma, Carrelizumab combined with apatinib and temozolomide has synergistic antitumor effects and may improve pathological response.
Inclusion: 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: Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy; Received a live vaccine within 4 weeks of the first dose of study medication; 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; Pregnancy or breast feeding; Decision of unsuitableness by principal investigator or physician-in charge.