This study is an open-label, Phase Ib clinical study to evaluate Evaluate the Recombinant Human GM-CSF Herpes Simplex Virus Injection (OrienX010) in Combination with Recombinant Human Anti-PD1 Monoclonal Antibody Injection (JS001) in the Treatment of Stage IV (M1c) Liver Metastasis from Melanoma. This study is planned to enroll approximately 30 patients with Stage IV (M1c) Liver Metastasis from Melanoma who meet protocol requirements. This study is a single-arm clinical trial. All participator will be given OrienX010 in combination with JS001. JS001 injection: 3 mg/kg, IV infusion: Once every 2 weeks ; OrienX010: Maximum injection volume 8 × 10\^8 pfu, intratumoral injection: Once every 2 weeks. Treatment will be continuous and extend from first dose of study medication until to complete response, clinical related progression disease (PDr), intolerable AE, or withdrew informed consent or meet other criteria of discontinuation. For patients who have stopped the study treatment and no disease progression, follow-up visits will take place every 3 months after the end of treatment visit until the occurrence of disease progression. If disease progression occurred, the investigator will collect the anticancer treatment information and survival of individuals until 80% death event.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
OrienX010 Produced by Oriengene Biotechnology Co., Ltd. Strength: 1.0 mL/vial. Label claim: Titer 8.0 × 10\^7Pfu/mL, NMT 1 × 10 particles11VP/mL. JS001 Produced by Junshi Biosciences Co., Ltd. Strength: 240 mg/6 mL/vial; Sterile water injection dosage form; Expiry date: 24 months; Date of manufacture: Based on the date of manufacture indicated in the product package.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGPFS
Progression-free survival (PFS), defined as the first documentation of objective disease progression, according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1)
Time frame: From date of enrolling until subjects disease progressive, an average of 16 weeks
ORR
Objective Response Rate (ORR), defined as complete or partial tumor response, according to RECIST v.1.1 criteria
Time frame: From date of enrolling until the date of all patients disease progression , an average of 20 months.
OS
Overall survival defined as the time from randomization to death from any cause
Time frame: Approximately 3 years
Quality of life assessment
Use EORTC QLQ-C30 to assess quality of life. The EORTC(European Organization for Research and Treatment of Cancer) QLQ-C30 (Quality of Life Questionnaire C30), is a cancer-specific quality of life instrument applicable to a broad range of cancer patients. QLQ-C30 contain 15 domain, The standard score for each domain from 0-100. higher scores mean a worse outcome.
Time frame: every 8 weeks, up to the date of 28 days after stopping treatment, an average of 24 weeks
Incidence of SAE and AE
Number of AE (adverse events) and SAE (serious adverse events) occurrences, Number of participants with treatment-related SAE and AE that assessed by CTCAE v5.0
Time frame: From date of enrolling to 90 days after stopping treatment, an average of 20 months
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