NCT05664139

Recombinant Human Adenovirus Type 5 Injection Combined With PD-1 Monoclonal Antibody and Nab-paclitaxel in the Treatment of Patients With Liver Metastases From Malignant Melanoma

A Prospective, Single-arm Study on 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 From Malignant Melanoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Malignant Melanoma
• Liver Metastases

Interventions

Type	Name	Description
DRUG	Recombinant Human Adenovirus Type 5 Injection,Camrelizumab,Nab-paclitaxel	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.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2022-12-23
• Last updated: 2023-02-08