Combination therapy for high-risk acral melanoma before surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.