At a glance
ClinicalIndex Comparison RecordPhase 3Recruiting· 200 target
Drug / intervention
PD1/PDL1 inhibitordrug
Likely dose
Not stated in record
Key inclusion· 7
- ✓Cytohistological confirmation of HCC diagnosis
- ✓Age 18-80 years with estimated survival >3 months
- ✓Child-Pugh class A or B with score >7; ECOG <2
- ✓Tolerable or reversible coagulation function
Key exclusion· 15
- ✕Participation in clinical trials within 4 weeks
- ✕Ascites, hepatic encephalopathy, or esophageal/gastric varices bleeding
- ✕Serious accompanying disease including heart disease, uncontrolled diabetes, psychiatric disorders
- ✕Other malignancies or past history of malignancy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II/III Randomized Trial of Comparison of Survival Benefit of Administration of PD1/PDL1/CTLA4 Inhibitor or Their Combinations Via Hepatic Arterial Infusion Versus Vein for Immunotherapy of Advanced Liver Cancer
Second Affiliated Hospital of Guangzhou Medical University·interventional·Posted May 14, 2019·Updated Jun 26, 2024
In Brief
A Phase 3 clinical trial evaluating PD1/PDL1 inhibitor for Liver Cancer. Currently recruiting, targeting 200 participants across 1 site.
Detailed Summary
This trial was designed to investigate the survival outcomes, response rates, and safety of patients with Barcelona-Clinical Hepatocellular Carcinoma (BCLC)-C-stage liver cancer by hepatic artery versus vein infusion of PD1/PDL1/CTLA4 inhibitor or their combinations.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Cancer
CountriesChina
Collaborators--
Timeline
Phase 3Recruiting
20192020202120222023202420252026202720282029203020312032203320342035203620372038
Enrollment StartJan 2019
First PostedMay 2019
TodayJul 2026
Primary CompletionJan 2029
Study CompletionJan 2038
First PostedMay 14, 2019
Enrollment StartJan 1, 2019
Primary CompletionJan 1, 2029
Study CompletionJan 2, 2038
TodayJul 1, 2026
Enrollment to primary: 10 yearsPosted 7.1 years agoPrimary completion in 2.5 years
Interventions
PD1/PDL1 inhibitordrug
Infusion of PD1/PDL1 inhibitor through peripheral vein or hepatic artery.