Combining Cardonilizumab Injection with TKI for Advanced Liver Cancer

Evaluation of the Efficacy and Safety of Cardonilimab Injection Combined With TKI as Second-line Treatment for Advanced Hepatocellular Carcinoma: A Single-arm, Open-label, Multicenter Real-world Clinical Study

This study is testing if a new injection called cardonilizumab, used with another cancer drug, can help people with advanced liver cancer who haven't responded well to previous treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (other)
• Drugs / interventions: chemotherapy, cardonilizumab
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06363006 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of cardonilizumab injection in combination with TKI as a second-line treatment for patients with advanced hepatocellular carcinoma. Participants must have experienced progression or intolerance after at least one prior systemic treatment. Cardonilizumab is administered every two weeks for up to 24 months, with continuous monitoring for potential infusion reactions. The study aims to assess various outcomes, including objective response rate, disease control rate, and overall survival.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed hepatocellular carcinoma who have experienced progression after prior systemic therapy.

Not a fit: Patients with early-stage liver cancer or those who have not received prior systemic treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced liver cancer who have not responded to previous therapies.

How similar studies have performed: While this approach is novel, previous studies have explored similar combinations in cancer treatment, showing varying degrees of success.

Eligibility criteria

Inclusion Criteria:Participants must meet all of the following inclusion criteria to be admitted to the study:

1. 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 carcinoma.
2. Age ≥18 and ≤75 years old.
3. ECOG physical status score 0 or 1.
4. 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.
5. Progression or intolerance after receiving at least one systemic antitumor therapy for hepatocellular carcinoma prior to initial administration
6. 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, injection of anhydrous ethanol or acetic acid, cryoablation, high-intensity focused ultrasound, transarterial embolization chemotherapy, transarterial embolization, etc., can be measured repeatedly.
7. Child-Pugh Level A.
8. Any treatment-related toxicity (due to prior treatment) must be resolved to baseline or stable prior to enrollment, except for hair loss.

Exclusion Criteria:Participants who meet any of the following criteria will not be eligible to participate in the study:

1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma and other components previously confirmed by histology/cytology.
2. History of hepatic encephalopathy.
3. History of liver transplantation.
4. There is clinically significant pericardial effusion; There are clinical symptoms of a pleural effusion requiring drainage.
5. 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.
6. Co-infection with HBV and HCV (a history of HCV infection but negative HCV RNA can be considered not infected with HCV).
7. There is central nervous system metastasis or meningeal metastasis.
8. Bleeding from esophageal or fundus varices caused by portal hypertension occurred within 6 months before the first dose Event. A gastroscopy must have been performed within 6 months prior to initial dosing, and participants with severe (G3) varicose veins were not allowed to participate in the study.
9. 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

Where this trial is running

Beijing, Beijing Municipality

• Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH) — Beijing, Beijing Municipality, China (RECRUITING)

Conditions: Hepatocellular Carcinoma