Hepatocellular Carcinoma study: TKI+Cardunilimab
Official title Combination of Cardonizumab Injection and TKI Second Line Therapy for Advanced Hepatocellular Cancer
ClinicalTrials.gov ID: NCT06363006
What this study is testing
What is TKI+Cardunilimab?
TKI+Cardunilimab is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate the efficacy and safety of cardonilizumab injection combined with TKI in second-line treatment of advanced hepatocellular carcinoma. The main questions it aims to answer are: Objective response rate (ORR) for evaluation Disease Control Rate (DCR); Duration of relief (DoR); Progression free survival (PFS); Total survival time (OS); Safety。
- Phase 1: an early, usually small safety study
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients with histologically/cytologically confirmed hepatocellular carcinoma or cirrhosis meet the clinical diagnostic criteria of the American...
- Age ≥18 and ≤75 years old.
- ECOG physical status score 0 or 1.
- Barcelona Clinic Liver Cancer (BCLC) stage C; It is not suitable for radical surgery and/or local treatment or stage B that progresses irremediably...
- Progression or intolerance after receiving at least one systemic antitumor therapy for hepatocellular carcinoma prior to initial administration
You likely can't join if
- Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma and other components previously confirmed by histology/cytology.
- History of hepatic encephalopathy.
- History of liver transplantation.
- There is clinically significant pericardial effusion; There are clinical symptoms of a pleural effusion requiring drainage.
- Clinically significant ascites are defined as meeting the following criteria: ascites can be detected by physical examination during screening or...
- Co-infection with HBV and HCV (a history of HCV infection but negative HCV RNA can be considered not infected with HCV).
See the full eligibility criteria
- Patients with histologically/cytologically confirmed hepatocellular carcinoma or cirrhosis meet the clinical diagnostic criteria of the American Association for the Study of Liver Diseases (AASLD) for hepatocellular...
- Age ≥18 and ≤75 years old.
- ECOG physical status score 0 or 1.
- Barcelona Clinic Liver Cancer (BCLC) stage C; It is not suitable for radical surgery and/or local treatment or stage B that progresses irremediably after surgery and/or local treatment.
- Progression or intolerance after receiving at least one systemic antitumor therapy for hepatocellular carcinoma prior to initial administration
- According to RECIST v1.1, there is at least one untreated measurable lesion or one that has been locally treated (e.g., Measurable lesions with clear progression (RECIST v1.1 standard) after radiofrequency ablation...
- Child-Pugh Level A.
- Any treatment-related toxicity (due to prior treatment) must be resolved to baseline or stable prior to enrollment, except for hair loss.
- Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma and other components previously confirmed by histology/cytology.
- History of hepatic encephalopathy.
- History of liver transplantation.
- There is clinically significant pericardial effusion; There are clinical symptoms of a pleural effusion requiring drainage.
- Clinically significant ascites are defined as meeting the following criteria: ascites can be detected by physical examination during screening or ascites need to be drained during screening.
- Co-infection with HBV and HCV (a history of HCV infection but negative HCV RNA can be considered not infected with HCV).
- There is central nervous system metastasis or meningeal metastasis.
- Bleeding from esophageal or fundus varices caused by portal hypertension occurred within 6 months before the first dose Event.
- Patients with any physical signs or history of bleeding, regardless of severity; Patients with any bleeding or bleeding event ≥CTCAE grade 3 within 4 weeks prior to initial dosing
The study team makes the final eligibility decision.
Where it is enrolling
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Beijing, Beijing Municipality, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.