Actively Recruiting
A Phase 2 Trial of Neoadjuvant Camrelizumab Plus Apatinib and Temozolomide in High-Risk Stage III-IIC Acral Melanoma
Led by Peking University Cancer Hospital & Institute · Updated on 2025-03-03
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of neoadjuvant therapy in patients with stage III and IIB, IIC high-risk acral melanoma. This study focuses on combining Camrelizumab with Apatinib and Temozolomide to explore their potential synergistic antitumor effects and to improve the pathological response rate. Previous studies at this site showed promising clinical response and safety for this combination in unresectable acral melanoma, and this trial aims to assess its benefits in resectable cases. Participants will receive two cycles of neoadjuvant therapy combining Camrelizumab, Apatinib, and Temozolomide before undergoing surgery to remove melanoma. After surgery, patients will continue with adjuvant treatment of Camrelizumab every three weeks for one year. This design allows researchers to study both short-term and long-term effects of this treatment approach. Throughout the study, participants will be monitored for pathological response at weeks 8 to 12 as the primary outcome. Secondary outcomes include objective response rate within six months, recurrence-free survival at one and two years, overall survival up to ten years, safety and tolerability of treatments and surgery, and patient-reported quality of life. The trial spans treatment, surgery, and follow-up periods to gather comprehensive data on efficacy and safety.
CONDITIONS
Brief Title
Camrelizumab Plus Apatinib and Temozolomide as Neoadjuvant in High Risk Acral Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, male or female
- Histopathologically confirmed acral melanoma at stage III or IIB/IIC
- No prior systemic anti-tumor drug treatment
- Measurable disease based on RECIST 1.1 criteria
- ECOG performance status of 0-1
- Adequate organ function
- Life expectancy greater than 12 weeks
- Provided written informed consent
You will not qualify if you...
- Currently receiving or have received chemotherapy, radiation, targeted therapy, or immunotherapy
- Known allergy to apatinib, temozolomide, or Camrelizumab
- Presence of other malignant tumors except cured skin basal cell carcinoma or cervical carcinoma in situ
- Active or history of autoimmune disease
- Unstable systemic diseases such as serious infection, uncontrolled diabetes, heart or cerebrovascular conditions
- Received live vaccine within 4 weeks before first study dose
- Pregnant or breastfeeding
- Investigator's decision of unsuitability for the study
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8 weeks
Participants receive neoadjuvant therapy with a combination of Camrelizumab, Apatinib, and Temozolomide for 2 cycles before surgery.
Visits every 3 weeks during treatment cycles
Duration - Single day procedure with recovery period
Participants undergo melanoma surgery after completing neoadjuvant therapy.
1 visit for surgery and immediate post-operative care
Duration - 1 year
Participants receive Camrelizumab every 3 weeks for 1 year after surgery to reduce risk of cancer recurrence.
Regular visits every 3 weeks for treatment administration
Duration - Up to 90 days after last dose and longer-term survival monitoring up to 10 years
Participants are monitored for safety, tolerability, quality of life, and long-term outcomes after completing adjuvant treatment.
Periodic follow-up visits for assessments
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
J
Jun Guo
L
Lili Mao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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