Last updated: April 9, 2024
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting
Phase
1
Condition
Abdominal Cancer
Cancer/tumors
Liver Cancer
Treatment
TKI+Cardunilimab
Clinical Study ID
NCT06363006
K23C3280
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:Participants must meet all of the following inclusion criteria to beadmitted to the study:
- Patients with histologically/cytologically confirmed hepatocellular carcinoma orcirrhosis meet the clinical diagnostic criteria of the American Association for theStudy of Liver Diseases (AASLD) for hepatocellular carcinoma.
- 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 surgeryand/or local treatment or stage B that progresses irremediably after surgery and/orlocal treatment.
- Progression or intolerance after receiving at least one systemic antitumor therapy forhepatocellular carcinoma prior to initial administration
- According to RECIST v1.1, there is at least one untreated measurable lesion or onethat has been locally treated (e.g., Measurable lesions with clear progression (RECISTv1.1 standard) after radiofrequency ablation, injection of anhydrous ethanol or aceticacid, cryoablation, high-intensity focused ultrasound, transarterial embolizationchemotherapy, transarterial embolization, etc., can be measured repeatedly.
- Child-Pugh Level A.
- Any treatment-related toxicity (due to prior treatment) must be resolved to baselineor stable prior to enrollment, except for hair loss.
Exclusion
Exclusion Criteria:Participants who meet any of the following criteria will not be eligibleto participate in the study:
- Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma and othercomponents previously confirmed by histology/cytology.
- History of hepatic encephalopathy.
- History of liver transplantation.
- There is clinically significant pericardial effusion; There are clinical symptoms of apleural effusion requiring drainage.
- Clinically significant ascites are defined as meeting the following criteria: ascitescan be detected by physical examination during screening or ascites need to be drainedduring screening.
- Co-infection with HBV and HCV (a history of HCV infection but negative HCV RNA can beconsidered not infected with HCV).
- There is central nervous system metastasis or meningeal metastasis.
- Bleeding from esophageal or fundus varices caused by portal hypertension occurredwithin 6 months before the first dose Event. A gastroscopy must have been performedwithin 6 months prior to initial dosing, and participants with severe (G3) varicoseveins were not allowed to participate in the study.
- 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 toinitial dosing
Study Design
Total Participants: 40
Treatment Group(s): 1
Primary Treatment: TKI+Cardunilimab
Phase: 1
Study Start date:
March 11, 2024
Estimated Completion Date:
January 01, 2027
Study Description
Connect with a study center
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH)
Beijing, Beijing 100730
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.