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| Name | Class |
|---|---|
| Jiangsu Hengrui Pharmaceutical Co., Ltd. | INDUSTRY |
| SunWay Biotech Co., LTD. | INDUSTRY |
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This study is the first to explore the efficacy and safety of recombinant human adenovirus type 5 injection combined with PD-1 monoclonal antibody and nab-paclitaxel in the treatment of patients with liver metastases of melanoma, in order to provide a new method for the clinical treatment of melanoma. The model also provides reference and basis for other tumor treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Adenovirus Type 5 Injection,Camrelizumab,Nab-paclitaxel | Drug | Recombinant Human Adenovirus Type 5 Injection:①the longest diameter of the lesion≥10mm and≤40mm, inject 1ml into the tumor each time;②the longest diameter of the lesion≥40mm and≤80mm, inject 2ml into the tumor each time. planned injections at D1. Every 3 weeks is a period, a total of 4 cycles; if there are visceral and superficial lesions at the same time, the injection lesions will be selected by the investigator based on possible benefits. Camrelizumab:200mg/time.Intravenous within 48 hours after injection of recombinant human adenovirus type 5 injection. Every 3 weeks is a period, and the treatment is continued until the subject has disease progression or unacceptable toxicity or death. Nab-paclitaxel:260mg/m2, D1, every 3 weeks as a period, a total of 4-6 cycles (determined by the investigator), or continue treatment until the subject has disease progression or Intolerable toxicity or death. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective tumor response rate (ORR) | From the first administration of the study drug to disease progression, unacceptable toxicity, withdrawal of informed consent or termination of the study (up to 1 year), including the proportion of CR and PR among all patients. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | It refers to the proportion of patients whose tumor shrinks or stabilizes and keeps for a certain period of time, including CR, PR and SD cases among all patients. | 1 year |
| Progression-free survival (PFS) |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological changes of injection lesions | Detection of pathologically-based changes in injected lesions | 1 year |
| MRI-based changes in injected lesions | Detection of MRI-based changes in injected lesions |
Inclusion Criteria:
Age ≥ 18 years old, and ≤ 75 years old, gender is not limited;
Patients with liver metastasis of malignant melanoma diagnosed by histopathology;
There must be an injectable lesion in the liver, and the lesion must meet the requirements of RECIST 1.1 measurable target lesion;
The liver lesion needs to be judged by the surgeon to have a poor prognosis in biological behavior; or the surgeon judges that it can be resected, but the patient refuses the operation, and the liver metastases must meet the following requirements:
ECOG physical condition score 0-1 points;
Expected survival time > 3 months;
Laboratory examinations meet the following standards:
The interval between the date of the first treatment in this study and the date of the last anti-tumor treatment in the past is ≥14 days, and the adverse reactions of the previous anti-tumor treatment have recovered to baseline or below grade 1 [evaluation criteria for common adverse events (CTCAE version 5.0)] (hair loss and grade 2 anemia);
Volunteer to participate in this study and sign the informed consent;
Female patients of childbearing age or male patients whose sexual partner is female of childbearing age should take effective contraceptive measures throughout the treatment period and 6 months after the last medication.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Chen, PhD | Contact | 13859089836 | 13859089836@139.com |
| Name | Affiliation | Role |
|---|---|---|
| Yu Chen, PhD | Fujian Cancer Hospital | Study Director |
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|
The time (days) from the date of randomization to the first observation of disease progression (based on imaging), if the patient died of other causes before disease progression, the time from the date of randomization to death was calculated number of days.
| 1 year |
| One-year Overall Survival | 1-year overall survival rate | 1 year |
| Quality of life (QoL) | EORTC QLQ-C30 | 1 year |
| Adverse event collection | Incidence of adverse reactions | 1 year |
| 1 year |
| Changes of CD4+ cells count, CD8+ cells count, Th1 cells count, Th2 cells count, Treg cells count in peripheral blood | Changes of CD4+ cells count, CD8+ cells count, Th1 cells count, Th2 cells count, Treg cells count in peripheral blood | 1 year |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| 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 |
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