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

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University Cancer Hospital & Institute
• Treatments: Apatinib; Temozolomide

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.