RecruitingPhase 2NCT05512481

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

A Phase 2 Clinical Trial of Neoadjuvant Camrelizumab Plus Apatinib and Temozolomide in High Risk Clinical Stage Ⅱ-Ⅲ Acral Melanoma


Sponsor

Peking University Cancer Hospital & Institute

Enrollment

60 participants

Start Date

Sep 13, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of three drugs — camrelizumab (immunotherapy), apatinib (a targeted therapy), and temozolomide (chemotherapy) — as a treatment given before surgery (neoadjuvant) for patients with high-risk acral melanoma. Acral melanoma is a rare skin cancer that occurs on the hands, feet, or under nails and is often harder to treat. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with acral melanoma at stage II or III, confirmed by biopsy - You have not received any prior systemic (whole-body) cancer treatment - Your cancer can be measured on imaging - You are in good general health (ECOG 0–1) **You may NOT be eligible if...** - You have already received chemotherapy, immunotherapy, or targeted therapy for melanoma - You have another active cancer - You are allergic to any of the study drugs - You are pregnant or breastfeeding - You have a serious autoimmune condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCamrelizumab

NEOADJUVANT: All participants will receive neoadjuvant therapy with combination of Camrelizumab、Apatinib and Temozolomide for 2 cycle; SURGERY: All participants will have melanoma surgery after 2 cycles of treatment ADJUVANT: Participants will receive Camrelizumab every 3 weeks for 1 year


Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

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NCT05512481


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