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

Sponsor
Fujian Cancer Hospital
Study ID
NCT05664139
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Feb 28, 2023
Status verified
Dec 2022
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm
    * Recombinant Human Adenovirus Type 5 Injection: 1ml or 2ml, d1, q3w, 4 cycles; * Camrelizumab: 200mg, d2, q3w; * Nab-paclitaxel: 260mg/m2, d1, q3w, 4-6 cycles;

Primary Outcome Measure

Objective tumor response rate (ORR) [ Time Frame: 1 year ]

Central Contacts

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