A Study of Cadonilimab Combined With AK112 as Second-line Therapy in Patients With Advanced Hepat… (NCT06196775) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Study of Cadonilimab Combined With AK112 as Second-line Therapy in Patients With Advanced Hepatocellular Carcinoma
China36 participantsStarted 2024-01-31
Plain-language summary
To evaluate the efficacy and safety of cadonilimab combined with AK112 as second-line therapy in patients with advanced 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:
* Histopathologically confirmed HCC
* Age 18-75 years old
* ECOG PS 0-1
* Child Pugh A-B7
* Patients who progressed on first-line standard system therapy (immunotherapy combined with Anti-angiogenesis targeting regimen) or with intolerable toxicity
* At least one measurable lesion (RECIST 1.1)
* Enough organ and bone marrow function
* Expected survival time≥12 weeks
* Sign a written informed consent and be able to comply with the visit and related procedures required by the study protocol
Exclusion Criteria:
* Severe complications due to primary liver disease
* No prior systemic therapy for advanced or metastatic primary hepatocellular carcinoma
* Malignant diseases other than primary hepatocellular carcinoma were diagnosed within 5 years prior to first administration
* Previous treatment with drugs that synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137)
* Autoimmune immune disease
* History of HIV
* Prognent women
* The presence of any serious or uncontrolled systemic disease
* Medical history or evidence of disease that may interfere with the test results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment. The Investigator considers that there are other potential risks that are not suitable for participation in the study.
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
Progression-Free-Survival
Timeframe: From the first drug administration up to two years