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Cadonilimab in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma

ConditionHepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHunan Cancer Hospital

About this trial

This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of Cadonilimab(AK104) in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The written informed consent form should be signed before a subject participates in the trial；

Histologically/cytologically confirmed HCC or cirrhosis meeting the clinical diagnostic criteria of HCC by the American Association for the Study of Liver Diseases (AASLD)；

According to the Chinese Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 edition), eligible for China liver cancer staging (CNLC) Stage IIIa and is not suitable for radical treatment, such as resection, ablation, or liver transplantation. Suitable for HAIC surgery and chemotherapy drugs prescribed in advance by the research center, without any contraindications to HAIC surgery and chemotherapy drugs；

Child-Pugh A or B；

Disqualifiers

Containing components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma that have been previously confirmed by histology/cytology;

Recurrence of previous hepatocellular carcinoma；

Autoimmune hepatitis (requires liver puncture)

Have a history of hepatic encephalopathy or liver transplantation;

Trial design

Design model

Single group

Treatments tested in this trial

  • Cadonilimab

    Drug

    Injectable solution

  • Lenvatinib

    Drug

    capsule

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Experimental: Cadonilimab +Lenvatinib+Hepatic Arterial Infusion Chemotherapy (HAIC)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate

ORR is the proportion of patients with best response of complete response (CR) and PR

Time frame
from the first drug administration up to two years

Secondary outcomes

1

Progression-free Survival (PFS)

Time from the date of first study treatment administration to the date of first documented tumor progression or death due to any cause, whichever occurs first

Time frame
Time Frame: from the first drug administration up to two years
2

Disease Control Rate (DCR)

Proportion of patients whose best overall response is either CR, PR, or SD

Time frame
from the first drug administration up to two years
3

Duration of Response(DOR)

Time from first documented response (CR or PR) until documented disease progression or death, whichever occurs first

Time frame
from the first drug administration up to two years
4

Overall Survival(OS)

Time from the date of first study treatment administration to the date of death due to any cause

Time frame
from the first drug administration up to two years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hunan Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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