A Study of Cadonilimab Combined With Regorafenib in Patients With Advanced HCC (NCT05773105) | Clinical Trial Compass
CompletedPhase 1/2
A Study of Cadonilimab Combined With Regorafenib in Patients With Advanced HCC
China36 participantsStarted 2023-09-19
Plain-language summary
To evaluate the efficacy and safety of cadonilimab combined with regorafenib in patients with HCC who progressed on systemic therapy.
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
. Patients who have signed ICF and are able to perform follow-up visits and relevant procedures required in the protocol
. Age 18-75
. Histologically or pathologically confirmed hepatocellular carcinoma
. Barcelona Clinic Liver Cancer (BCLC) stage of B or C or CNLC IIb-IIIb, for those unsuitable for radical surgery and/or local treatment
. Previously treated with anti-vascular targeting combined with or without anti-PD-1/PD-L1 agents for HCC, with disease progression or intolerable toxicity
. Child-Pugh score of ≤ 7
. ECOG PS of 0 or 1
. At least 1 measurable lesion (according to RECIST1.1)
. 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.
1This trial combined cadonilimab, an immunotherapy drug, with regorafenib for advanced liver cancer — given that it's a Phase 1/2 study, what does that mean for how much is known about the safety and effectiveness of this specific combination?
2The main thing this trial measured was whether patients went at least 6 months without their cancer getting worse — based on the results that have been reported, how does that compare to what I might expect from standard treatment options available to me right now?
3Regorafenib is known to have side effects like fatigue, hand-foot syndrome, and high blood pressure — do you think I could realistically manage those side effects on top of an immunotherapy like cadonilimab given my current health situation?
4Since this trial has already completed, is there published data from it that you could review with me, and would any of those findings change what treatment path you'd recommend for me?
5Are there currently open trials or approved therapies building on this kind of immunotherapy-plus-regorafenib approach that might be worth considering as an alternative or next step?
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
6-month progression-free survival (PFS) rate
Timeframe: At the end of Cycle 2 (each cycle is 21 days)
. 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 10\^4 copies/mL; hepatitis C virus (HCV) RNA \> 10\^3 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 veins 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.
. Any arterial/venous thromboembolic events within 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient cerebral ischemic attack, pulmonary embolism, deep vein thrombosis, or any other history of serious thromboembolism. Presence of implantable venous port or catheter-derived thrombosis, or superficial venous thrombosis, barring stable thrombosis following the conventional anticoagulation treatment. Prophylactic use of low-dose low-molecular-weight heparin (e.g., enoxaparin 40 mg/day) is permitted.