Camrelizumab Plus Apatinib and Temozolomide as Neoadjuvant in High Risk Acral Melanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University Cancer Hospital & Institute
About this trial
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
This trial does not accept healthy volunteersQualifiers
age:18-75 years, male or female.
Histopathologically confirmed acral melanoma (stage Ⅱ/Ⅲ).
Has not received any systematic anti-tumor drug treatment.
Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Disqualifiers
Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
Known history of hypersensitivity to any component of apatinib, temozolomide, Camrelizumab.
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
Trial design
Design model
Single group
Treatments tested in this trial
Camrelizumab
DrugNEOADJUVANT: 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
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Neoadjuvant/adjuvant therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pathological response rate
The primary endpoint is the pathological response rate at surgery after neoadjuvant study treatment. The pathological response is categorised thus: Complete pathological response (pCR) - 0% viable tumour cells in the surgical specimen Near complete pathological response - (near pCR) - \<10% viable tumour Partial pathological response (pPR) - 10%-50% viable tumour No pathological response (pNR) - \>50% viable tumour
Time frame
Week 8-12Secondary outcomes
1
Objective Response Rate
Disease Response as assessed by RECIST 1.1 and mRECIST
Time frame
Months 0-62
Recurrence-free survival
The proportion of patients with an histologically confirmed diagnosis of disease recurrence (local, regional, and distant), as detected by the patient, on physical examination or during imaging surveillance, or death from any cause.
Time frame
1year,2year3
Overall survival
The proportion of participants deceased from any cause.
Time frame
10 years4
Safety and tolerability of neoadjuvant and adjuvant treatment and surgical procedures.
The proportion of patients with adverse events as described in CTCAE version 5.0
Time frame
90 days from last dose of study treatmentSponsors and contacts
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Source ClinicalTrials.gov