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

NCT06363006 | Recruiting Phase 1

• 1 other identifier: K23C3280
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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。

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• ORR Full single-arm, open, multicenter prospective clinical study

  Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.

  3 years

• Progression-free Survival (PFS)

  A duration from the date of initial treatment with TKI plus Cardonizumab to disease progression (defined by RECIST 1.1) or death of any cause.

  1.5 years

Secondary Outcomes (5)

• Disease Control Rate (DCR)

  3 years

• Overall Survival (OS)

  3 years

• Duration of Response (DOR)

  3 years

• Stable Disease (SD)

  3 years

• Progression free survival rate

  1.5 years

Other Outcomes (1)

• Any adverse events related with treatment with TKI plus Cardonizumab.

  3 years

Study Arms (1)

TKI+Cardonilizumab

EXPERIMENTAL

TKI:Tyrosine kinase inhibitors can serve as competitive inhibitors of adenosine triphosphate (ATP) binding to tyrosine kinase, as well as analogues of tyrosine, blocking the activity of tyrosine kinase and inhibiting cell proliferation. Cardonilizumab:It can block the interaction between PD-1, CTLA-4 and their ligands PD-L1/PD-L2, B7.1/B7.2, thereby blocking the immunosuppressive response of the PD-1 and CTLA-4 signaling pathways, promoting tumor specific T cell immune activation, and inhibiting tumor cell growth.

Drug: TKI+Cardunilimab

Interventions

TKI+Cardunilimab DRUG

Cardonilizumab 6mg/kg, IV, Q2W + lenvatinib 8mg (body weight \< 60kg) or 12mg(body weight ≥60kg) PO, QD, / Sorafenib 400mg, PO, BID/ Regorafenib 160mg, PO, QD/ Donafenib 200mg, PO, BID。 omniscience

TKI+Cardonilizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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, injection of anhydrous ethanol or acetic acid, cryoablation, high-intensity focused ultrasound, transarterial embolization chemotherapy, transarterial embolization, etc., can be measured repeatedly.
• 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.

You may not qualify 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 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. 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.
• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 12, 2024
• Study Start: March 11, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)