HAIC Combined With Durvalumab, Tremelimumab and Bevacizumab as Conversion Therapy for Potentially… (NCT05864755) | Clinical Trial Compass
UnknownPhase 2
HAIC Combined With Durvalumab, Tremelimumab and Bevacizumab as Conversion Therapy for Potentially Resectable Hepatocellular Carcinoma
China30 participantsStarted 2023-06-20
Plain-language summary
To evaluate the efficacy and safety of HAIC combined with Durvalumab, Tremelimumab and Bevacizumab as first-line therapy in Unresectable hepatocellular carcinoma
Who can participate
Age range
18 Years – 85 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
. Provide a written informed consent form (ICF) signed and dated by the patient/legal representative before conducting any research specific procedures, sampling, and analysis specified in the protocol.
. Before collecting genetic analysis samples (optional), provide a signed and dated written informed consent form for genetic research.
. At the time of screening, the age should be ≥ 18 years old. For patients under the age of 20 who are enrolled in China, written informed consent from the patient and their legal representative should be obtained.
. Based on the histopathology results of tumor tissue, a patient with stage C hepatocellular carcinoma complicated with portal vein tumor thrombus BCLC was diagnosed, with portal vein tumor thrombus type I to III. (Cheng's classification indicates that the tumor thrombus is mainly located at the level of the liver segment (secondary branch of the portal vein); Type II refers to the spread of cancer thrombi invading the left or right branch of the portal vein (primary branch of the portal vein); Type III refers to cancer thrombus invading the main portal vein; Type IV refers to tumor thrombus invading superior mesenteric vein or inferior vena cava.
. No evidence of extrahepatic diseases was found in baseline chest/abdominal/pelvic imaging
. The disease is not suitable for radical surgery, transplantation, or radical ablation
. The disease must be suitable for TACE and HAIC treatment, and it is expected that TACE treatment for local lesions will not exceed 4 times within 16 weeks \[DEB-TACE\]
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 IDNCT05864755
SponsorTianjin Medical University Cancer Institute and Hospital
. The Child Pugh grading of liver function is Grade A,the Eastern Oncology Collaborative Group (ECOG) physical fitness score was 0 or 1
Exclusion criteria
. History of kidney disease or nephrotic syndrome
. Cardiovascular diseases with clinical significance
. Major traumatic injury occurred within the first 4 weeks of randomization
. Known genetic factors for bleeding or thrombosis; Any previous or current evidence indicating a tendency to bleed
. Systematic anticoagulant therapy is allowed, except for vitamin K antagonists
. History of arterial embolism events, including stroke or myocardial infarction
. Patients with unhealed wounds, active ulcers, or fractures. For granulation wounds in the second stage of healing, as long as there is no evidence of surface cracking or infection in patients, they meet the inclusion criteria but require wound examination every 3 weeks
. Abdominal wall fistula or gastrointestinal perforation, refractory unhealed gastric ulcer, or active gastrointestinal bleeding within 6 months before enrollment