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

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT05512481
Phase
PHASE2
Status
Recruiting
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Conditions

  • Acral Melanoma
  • Apatinib
  • Camrelizumab
  • Melanoma
  • Neoadjuvant
  • Pathological Response
  • Temozolomide

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    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

Study Details

Neoadjuvant therapy is feasible in stage Ⅱ-Ⅲ melanoma, Carrelizumab combined with apatinib and temozolomide has synergistic antitumor effects and may improve pathological response.

Key Dates

Start date
Sep 13, 2022
Status verified
Feb 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant/adjuvant therapy
    Drug: Camrelizumab Drug: Apatinib mesylate Drug: Temozolomide Injection

Primary Outcome Measure

Pathological response rate [ Time Frame: Week 8-12 ]

Central Contacts

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