Combining Camrelizumab, Apatinib, and Temozolomide for Advanced Acral Melanoma Treatment

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 therapy involving camrelizumab, apatinib, and temozolomide as a first-line treatment for patients with advanced acral melanoma. It is a randomized controlled trial focused on assessing progression-free survival in participants who have not previously received systemic anti-tumor treatment. The study aims to determine if this combination can improve outcomes compared to standard treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* age:≥18 years, male or female.
* Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV).
* 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 Criteria:

* Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
* Known history of hypersensitivity to macromolecular protein preparation or any components of the drug formulation.
* 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 Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
* Received a live vaccine within 4 weeks before the first dose of study medication.
* Pregnancy or breast feeding.
* Decision of unsuitableness by principal investigator or physician-in charge.

Where it's running

• Beijing Cancer Hospital
  Beijing, China Recruiting

Study contacts

• Principal investigator: Jun Guo, Dr — Peking University Cancer Hospital & Institute
• Study coordinator: Jun Guo, Dr
• Email: guoj307@126.com
• Phone: 010-88121122

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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.