Combination therapy for high-risk acral melanoma before surgery
A Phase 2 Clinical Trial of Neoadjuvant Camrelizumab Plus Apatinib and Temozolomide in High Risk Clinical Stage Ⅱ-Ⅲ Acral Melanoma
This study is testing a new combination of treatments before surgery to see if it can help people with high-risk acral melanoma have better outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Drugs / interventions | Camrelizumab, apatinib, chemotherapy, immunotherapy, radiation, Carrelizumab |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05512481 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a combination of Camrelizumab, Apatinib, and Temozolomide as neoadjuvant therapy for patients with high-risk acral melanoma. The study aims to improve surgical outcomes and assess the pathological response to treatment in patients with resectable stage IIB, IIC, and III melanoma. By analyzing the response and resistance mechanisms, the trial seeks to provide insights into future treatment strategies for this patient population. Previous studies have indicated promising results for this combination in treating unresectable acral melanoma.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with histopathologically confirmed stage II or III acral melanoma who have not received prior systemic anti-tumor treatment.
Not a fit: Patients currently undergoing other cancer treatments or with active autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve surgical outcomes and long-term survival rates for patients with high-risk acral melanoma.
How similar studies have performed: Previous studies have shown promising results with similar neoadjuvant therapies for melanoma, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jun Guo — Peking University Cancer Hospital & Institute
- Study coordinator: Jun Guo
- Email: guoj307@126.com
- Phone: 86-10-88121122
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.