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Study of Oncolytic Virus in Combination With HX-008 and Radiotherapy in Melanoma Patients With Liver Metastasis

NCT05068453 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-10-05

No results posted yet for this study

Summary

Malignant melanoma, is a kind of malignant tumor derived from melanocytes. It is common in skin, mucous membrane, eye choroid and other parts. Melanoma is one of the fastest growing malignant tumors with an annual incidence rate of 3-5%. In 2012, there were 232000 new cases of melanoma and 55000 deaths worldwide. Though, the incidence rate of melanoma is relatively low in China, it has been increasing rapidly in recent years. Melanoma has seriously endangering the health of Chinese people.

Patients with stage Ⅳ melanoma have a poor prognosis. According to statistics, the median survival time of stage M1a melanoma is 15 months, while stage M1b is 8 months. The median survival time of bone metastasis melanoma is 6 months, while liver and brain metastasis is 4 months. The overall median survival time of metastatic melanoma is only 7.5 months, and the 2-year survival rate is 15%.

For patients with advanced melanoma, dacarbazine is the only chemotherapy drug approved by NMPA, but its overall effective rate is only 13.4%, and the median survival time is 5.6 \~ 11 months.

Therapies(new drugs or new combination treatments)with higher remission rate and longer survival are urgently needed for patients with advanced melanoma.

Conditions

  • Melanoma Stage IV

Interventions

DRUG

Recombinant Oncolytic HSV-2 Therapeutic Injecta (Vero Cell) for Human Use (rHSV2hGM-CSF)

OH2：less than 8mL/time，Q2W，i.t.；

DRUG

Recombinant humanized anti-PD-1 monoclonal antibody for injection

HX-008：200mg/time，Q3W，i.v.；

RADIATION

RT

3 times radiation，totally 24-30 Gy for each lession.

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2023-10-31
Completion
2023-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05068453 on ClinicalTrials.gov