RecruitingPhase 1NCT06363006

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


Sponsor

Peking Union Medical College Hospital

Enrollment

40 participants

Start Date

Mar 11, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining two immunotherapy drugs (cardonizumab, a PD-1 blocker) with a targeted blood vessel drug (TKI) is effective for people with advanced liver cancer (hepatocellular carcinoma) who have already tried at least one other treatment. **You may be eligible if...** - You have confirmed hepatocellular carcinoma (the most common type of liver cancer) - You are between 18 and 75 years old - Your cancer is advanced or cannot be surgically removed - You have already tried at least one systemic (whole-body) cancer treatment and it stopped working - You have at least one measurable tumor - Your liver and overall health are within acceptable ranges - Your ECOG performance score is 0 or 1 (able to carry out normal activity) **You may NOT be eligible if...** - Your liver is too weak to handle treatment - You have not tried any prior treatment - You have serious other health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTKI+Cardunilimab

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


Locations(1)

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

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06363006


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