To evaluate the efficacy of OH2 injection in patients with unresectable or metastatic melanoma who have failed at least second-line standard therapy, using investigator-selected salvage chemotherapy or best supportive care (BSC) as controls.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
340
Oncolytic Type 2 Herpes Simplex Virus
single or combined, including but not limited to dacarbazine, temozolomide, taxoid, or platinum
Overall survival (OS)
Overall survival is defined as the interval from first dose to death from any cause.
Time frame: From date of randomization until the date of death from any cause,assessed up to 3 years
Objective response rate (ORR)
Determination of the ORR is calculated based on the proportion of patients achieving CR or PR using the RECIST v1.1 and iRECIST as assessed by investigators.
Time frame: Tumor assessments were performed every 8 weeks in first year and every 12 weeks thereafter until confirmed PD, start of new anticancer treatment, death, withdrawal of informed consent, loss of follow-up, or the end of the study, assessed up to 3 years
Disease control rate (DCR)
DCR is defined as the percentage of participants with a best overall response of CR, PR, or SD.
Time frame: Tumor assessments were performed every 8 weeks in first year and every 12 weeks thereafter until confirmed PD, start of new anticancer treatment, death, withdrawal of informed consent, loss of follow-up, or the end of the study, assessed up to 3 years
Progression-free survival (PFS)
Progression-free survival is defined as the time from first dose to the earlier event of confirmed PD or death from any cause.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Durable Response Rate (DRR)
DRR is defined as the percentage of participants with a best overall response of CR or PR using the RECIST/iRECIST assessment with a duration of response of at least 6 months.
Time frame: Tumor assessments were performed every 8 weeks in first year and every 12 weeks thereafter until confirmed PD, start of new anticancer treatment, death, withdrawal of informed consent, loss of follow-up, or the end of the study,assessed up to 3 years
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Peking University Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGChongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGFujian Cancer Hosptial
Fuzhou, Fujian, China
RECRUITINGDermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGGuangxi Medical University Cancer Hospital
Nanning, Guangxi, China
NOT_YET_RECRUITINGHainan Cancer Hospital
Haikou, Hainan, China
NOT_YET_RECRUITINGThe Fourth Hospital of Hebei Medical University and Hebei Tumor Hospital
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGThe Third People's Hospital of Zhengzhou
Zhengzhou, Henan, China
RECRUITING...and 20 more locations
Duration of Response (DOR)
DOR is defined as the time from the first recording of remission (CR or PR) to the first recording of disease progression or death (whichever comes first)
Time frame: Tumor assessments were performed every 8 weeks in first year and every 12 weeks thereafter until confirmed PD, start of new anticancer treatment, death, withdrawal of informed consent, loss of follow-up, or the end of the study,assessed up to 3 years