HAIC Combined With Cadonilimab and Bevacizumab as First-line Therapy in Unresectable Hepatocellul… (NCT05821361) | Clinical Trial Compass
UnknownPhase 2
HAIC Combined With Cadonilimab and Bevacizumab as First-line Therapy in Unresectable Hepatocellular Carcinoma
China30 participantsStarted 2023-08-01
Plain-language summary
To evaluate the efficacy and safety of HAIC combined with Cadonilimab and bevacizumab as first-line therapy in Unresectable hepatocellular carcinoma
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. written informed consent signed prior to enrolment.
. age 18-75 years, both sexes.
. Histologically/cytologically confirmed HCC or cirrhosis meeting the clinical diagnostic criteria of HCC by American Association for the Study of Liver Diseases (AASLD).
. ECOG PS of 0 or 1.
. Absence of systemic anti-tumor treatment for HCC before the first dose.
. Barcelona Clinic Liver Cancer (BCLC) stage of C. Stage B for those unsuitable for radical surgery and/or local treatment.
. At least one measurable lesion according to RECIST V1.1, or measurable lesions showing definite progression following the local treatment based on RECIST V1.1.
. History of hepatic encephalopathy or liver transplantation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall response rate ( ORR) per RECIST 1.1
Timeframe: Up to 1 year
Trial details
NCT IDNCT05821361
SponsorTianjin Medical University Cancer Institute and Hospital
. Symptomatic pleural effusion, ascites, and pericardial effusion that require drainage.
. Acute or chronic active hepatitis B or C infection; hepatitis B virus (HBV) DNA \> 2000 IU/mL or 104 copies/mL; hepatitis C virus (HCV) RNA \> 103 copies/mL; hepatitis B surface antigen (HbsAg) and anti-HCV antibody positive concurrently. Those who possess the indicators lower than the above criteria after nucleotide antiviral treatment can be enrolled.
. Presence of metastasis to the central nervous system.
. Presence of bleeding events from esophageal or gastric varices caused by portal hypertension within the past 6 months. Presence of known severe (G3) varicose vein in endoscopy within 3 months before the first dose. Evidence of portal hypertension (including the finding of splenomegaly in imaging studies) with a high risk of bleeding assessed by the investigator.
. Presence of any life-threatening bleeding events within the past 3 months, including the need for transfusion, surgery or local treatment, and continuous medication therapy.
. Involvement of both the main portal vein and the left and right branches by portal vein tumor thrombus, or of both the main trunk and the superior mesenteric vein concurrently. Presence of tumor thrombus of inferior vena cava.