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Neoadjuvant therapy is feasible in stage Ⅱ-Ⅲ melanoma, Carrelizumab combined with apatinib and temozolomide has synergistic antitumor effects and may improve pathological response.
Patients with resectable melanoma can benefit from neoadjuvant therapy, including improved surgical outcomes, precise management of patients based on neoadjuvant response, and analysis of resistance mechanisms through histological sections for subsequent treatment. At present, there have been a number of clinical trials exploring the effect of neoadjuvant regimens for melanoma, and some published results have shown that neoadjuvant therapy can lead to a higher pathological response rate, thereby improving the RFS of patients.
In the past, this site has carried out a clinical study of Camrelizumab combined with Apatinib and Temozolomide for first-line treatment of unresectable acral melanoma, with a high preliminary clinical response rate and safety. Based on this, this study intends to evaluate the neoadjuvant treatment of completely resectable melanoma with Camrelizumab combined with Apatinib and Temozolomide in patients with stage III and IIB, IIC high-risk melanoma. To comprehensively evaluate the short-term and long-term benefits of neoadjuvant therapy and provide an important reference for neoadjuvant treatment strategies in the acral melanoma population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant/adjuvant therapy | Experimental | Drug: Camrelizumab Drug: Apatinib mesylate Drug: Temozolomide Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 8-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Disease Response as assessed by RECIST 1.1 and mRECIST | Months 0-6 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Guo | Contact | 86-10-88121122 | guoj307@126.com | |
| Lili Mao | Contact | yunzhongmanbu7848@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Guo | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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|
|
| 1year,2year |
| Overall survival | The proportion of participants deceased from any cause. | 10 years |
| 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 | 90 days from last dose of study treatment |
| Patient reported quality of life | The individual, summary and composite scores obtained from the validated EUROQOL QLQ-C30 questionnaires. | 90 days from last dose of study treatment |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |