A Phase 2 interventional study of Cadonilimab+TACE in Hepatocellular Carcinoma, sponsored by Eastern Hepatobiliary Surgery Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-29.
Sponsored by Eastern Hepatobiliary Surgery Hospital · Phase 2, Interventional, and Treatment
Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors. The goal of this clinical trial is to evaluated the efficacy and safety of cadonilimab combined with TACE in patients with intermediate-stage unresectable hepatocellular carcinoma.
6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's planned enrollment of 41 is close to the median of 45 across 5,174 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Eastern Hepatobiliary Surgery Hospital is the lead sponsor of 66 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cadonilimab (15mg/kg Q3W D1)+TACE
Drug: Cadonilimab+TACE
Cadonilimab: 15mg/kg Q3W Day1 Select the best TACE treatment strategy. Traditional TACE (cTACE) or DEB-TACE can be selected. TACE treatment can be continued as needed based on disease control. The combination of cadonilimab is given 3 to 7 days after the first TACE treatment, and the subsequent administration of cardonilizumab is given once every 3 weeks, if the time overlaps with TACE treatment, it is generally administered 3 to 7 days after TACE treatment. Treatment was discontinued until intolerable toxicity, death, withdrawal of informed consent, initiation of a new antitumor therapy, or other reason specified in the protocol, whichever occurs first. Patients in this study received cadonilimab for up to 24 months.
Objective response rate (ORR)
ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1.
Time frame: Up to 1 year
Progression free survival (PFS)
PFS is defined as the time from enrollment of the trial to the first documented disease progression or death due to any cause.
Time frame: Up to two years
Overall survival (OS)
The duration from the date of recruitment to the date of death from any cause.
Time frame: Up to two years
Adverse events (safety)
Adverse events (safety ) will be evaluated according to the NCI CTCAE Version 5.0.The number and severity of treatment-related side effects, including AE and SAE, will be recorded during treatment.
Time frame: Up to two years
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Eastern Hepatobiliary Surgery Hospital