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Safety and tolerability are assessed based on the incidence of Dose-Limiting Toxicities (DLTs) within 14 days post-initial drug administration, along with the frequency and severity of adverse events (AEs), serious adverse events (SAEs), and events leading to treatment discontinuation throughout the treatment period, all evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. According to Amendment 1, the primary endpoint has been amended from assessing the incidence and severity of DLTs, adverse events (AEs), serious adverse events (SAEs), and AEs leading to treatment discontinuation (evaluated per NCI-CTCAE 5.0) with HNF4α srRNA therapy to assessing these outcomes for both HNF4α srRNA monotherapy and combination therapy.
To assess the proportion of subjects who have best overall response of complete response or partial response at the time of data cutoff based on mRECIST. According to Amendment 1, the primary endpoint has been updated from evaluating the ORR per mRECIST with HNF4α srRNA therapy to evaluating the ORR for both monotherapy and combination therapy with HNF4α srRNA per mRECIST.
To assess the time from the first documentation of complete response or partial response to the date of first documentation of disease progression or death (whichever occurs first) based on mRECIST and RECIST v1.1
To assess the time from the first study dose date to the date of first documentation of disease progression based on mRECIST and RECIST v1.1
To assess the time from the date of first study dose to the date of first documentation of complete response or partial response based on mRECIST and RECIST v1.1
To assess the proportion of subjects who have best overall response of complete response or partial response or durable stable disease (duration of stable disease ≥ 23 weeks) based on mRECIST and RECIST v1.1
To assess the time from the first study dose date until date of death from any cause . Subjects who are lost to follow-up and the subjects who are alive at the date of data cutoff will be censored at the date the subject was last known alive or the cut-off date, whichever comes earlier.
To assess the time from the first study dose date to the date of first documentation of disease progression or death(whichever occurs first) based on mRECIST and RECIST v1.1
To assess the proportion of subjects who have best overall response of complete response or partial response or stable disease (minimum duration from the initial treatment to stable disease ≥5 weeks) based on mRECIST and RECIST v1.1
To evaluate the impact of CD-801 treatment on Health Related Quality of Life for subjects treated using HCC-specific EORTC QLQ-HCC18 questionnaire.
To evaluate the impact of CD-801 treatment on Health Related Quality of Life for subjects treated using European Quality of Life questionnaire.
To investigate the changes in serum tumor biomarkers among subjects with advanced HCC following CD-801 treatment.
To investigate the changes in serum cytokines among subjects with advanced HCC following CD-801 treatment.
To investigate the changes of immune cell profiling in serum among subjects with advanced HCC following CD-801 treatment.
To investigate the changes of histopathology in tumor tissue among subjects with advanced HCC following CD-801 treatment.
To investigate the changes of tumor metabolism through metabolomic analysis of liver cancer tissue among subjects with advanced HCC following CD-801 treatment.
To investigate the changes of tumor gene expression profiles through next-generation sequencing and single-cell sequencing analysis of liver cancer tissue among subjects with advanced HCC following CD-801 treatment.
To evaluate the impact of CD-801 treatment on Health Related Quality of Life for subjects treated using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).
To assess the proportion of subjects who have best overall response of complete response or partial response at the time of data cutoff based on mRECIST and RECIST v1.1. According to Amendment 1, this outcome has been updated from evaluating the ORR per mRECIST with HNF4α srRNA therapy to evaluating the ORR for both monotherapy and combination therapy with HNF4α srRNA per mRECIST and RECIST v1.1.
To assess the frequency and severity of AEs, SAEs, and events leading to treatment discontinuation throughout the treatment period, all evaluated using CTCAE 5.0. According to Amendment 1, this outcome has been amended from assessing the incidence and severity of DLTs, adverse events (AEs), serious adverse events (SAEs), and AEs leading to treatment discontinuation (evaluated per NCI-CTCAE 5.0) with HNF4α srRNA therapy to assessing these outcomes for both HNF4α srRNA monotherapy and combination therapy.
To assess the proportion of subjects who have best overall response of complete response or partial response at the time of data cutoff based on RECIST v1.1 According to Amendment 1, this outcome has been updated from evaluating the ORR per mRECIST with HNF4α srRNA therapy to evaluating the ORR for both monotherapy and combination therapy with HNF4α srRNA per mRECIST.