NCT05512481 Camrelizumab Plus Apatinib and Temozolomide as Neoadjuvant in High Risk Acral Melanoma
| NCT ID | NCT05512481 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking University Cancer Hospital & Institute |
| Condition | Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-09-13 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2022-09-13 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Jun Guo
PRINCIPAL INVESTIGATOR
Peking University Cancer Hospital & Institute
Frequently Asked Questions
Who can join the NCT05512481 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05512481 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05512481 currently recruiting?
Yes, NCT05512481 is actively recruiting participants. Contact the research team at guoj307@126.com for enrollment information.
Where is the NCT05512481 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05512481 clinical trial?
NCT05512481 is sponsored by Peking University Cancer Hospital & Institute. The principal investigator is Jun Guo at Peking University Cancer Hospital & Institute. The trial plans to enroll 60 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.