Combination of Cardonizumab Injection and TKI Second Line Therapy for Advanced Hepatocellular Cancer

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

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。

Eligibility Criteria

Inclusion

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

  1. 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.
  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 surgeryand/or local treatment or stage B that progresses irremediably after surgery and/orlocal treatment.
  5. Progression or intolerance after receiving at least one systemic antitumor therapy forhepatocellular carcinoma prior to initial administration
  6. 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.
  7. Child-Pugh Level A.
  8. 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:

  1. Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma and othercomponents 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 apleural effusion requiring drainage.
  5. 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.
  6. Co-infection with HBV and HCV (a history of HCV infection but negative HCV RNA can beconsidered 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 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.
  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 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

Have received at least one prior systemic treatment progression or intolerance for HCC. Cardonilizumab was administered every 2 weeks on the first day of each cycle for up to 24 months in the absence of investigator judgment that there is no longer a clinical continuation benefit, intolerable toxicity, initiation of a new antitumor therapy, withdrawal of informed consent, loss of follow-up, death, or other protocol requirements for treatment termination. Cardonilizumab will complete infusion within 60 minutes (± 10 minutes). Continuous monitoring of potential infusion reactions and allowing pre-treatment of hypersensitivity reactions or infusion rate adjustment according to protocol guidelines. For subjects who cannot tolerate a 60-minute infusion, the infusion time can be extended up to 120 minutes. Dose adjustment of cardonilizumab is not allowed during treatment, but delayed dosing is allowed for up to 12 weeks (since the last dosing time). If glucocorticoids are used in the treatment of irAE, In both cases where the glucocorticoid reduction process resulted in the suspension of cardonilizumab for more than 12 weeks, or in the treatment of AE that may or may not be related to cardonilizumab, and where the investigator determined that the patient would benefit from continued treatment, permission to continue treatment was required after discussion with the sponsor medical Ombudsman.

Connect with a study center

  • Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH)

    Beijing, Beijing 100730
    China

    Active - Recruiting

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