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HAIC, Lenvatinib, and Cadonilimab as Conversion Therapy for Initially Unresectable Hepatocellular Carcinoma

ConditionHepatocellular Carcinoma Non-resectable
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTongji Hospital

About this trial

This is an open-label, single-arm, phase 2 study evaluating hepatic arterial infusion chemotherapy (HAIC) combined with lenvatinib and cadonilimab as conversion therapy for initially unresectable hepatocellular carcinoma (HCC). The primary objective is to assess the conversion rate, defined as the proportion of participants who are deemed amenable to curative-intent treatment by the multidisciplinary team (MDT), including R0 resection, curative ablation, or liver transplantation, after study treatment. Secondary objectives include curative-intent intervention rate, tumor response, survival outcomes, safety, pathological response, and exploratory tissue and blood biomarkers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hepatocellular carcinoma proven on biopsy or confirmed by radiological hallmarks according to the American Association for the Study of Liver Diseases (AASLD) or the European Association for the Study of the Liver (EASL) guidelines.

Age ≥18 years.

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

R0 resection is not feasible.

Disqualifiers

Histologically or cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or mixed histology.

History of hepatic encephalopathy or liver transplantation.

Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage. Participants with only minimal radiologic effusion without symptoms may be enrolled.

Acute or chronic active hepatitis B or C infection, with HBV DNA >2000 IU/mL or 10^4 copies/mL, HCV RNA >10^3 copies/mL, or co-positivity for HBsAg and anti-HCV antibody. Participants controlled to within these limits after antiviral therapy may be enrolled.

Trial design

Design model

Single group

Treatments tested in this trial

  • Hepatic arterial infusion chemotherapy (HAIC-FOLFOX)

    Procedure/Surgery

    Administration of oxaliplatin, leucovorin, and fluorouracil via the tumor-feeding hepatic artery every 3 weeks.

  • Lenvatinib

    Drug

    Lenvatinib administered orally once daily at 8 mg for participants weighing ≤60 kg or 12 mg for participants weighing \>60 kg.

  • Cadonilimab

    Drug

    Cadonilimab administered intravenously at 10 mg/kg every 3 weeks.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: HAIC + lenvatinib + cadonilimabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Conversion rate

Proportion of participants who are deemed amenable to curative-intent treatment by the multidisciplinary team (MDT), including R0 resection, curative ablation, or liver transplantation, after study treatment. Conversion success will be confirmed only when MDT-defined amenability to curative-intent treatment is maintained for at least 2 months, unless curative-intent treatment is actually performed earlier.

Time frame
From the date of first treatment to confirmed MDT assessment of amenability to curative-intent treatment, assessed up to 2 years

Secondary outcomes

1

Curative-intent intervention rate

Proportion of participants who actually undergo curative-intent treatment, including R0 resection, curative ablation, or liver transplantation, after study treatment.

Time frame
From the date of first treatment to receipt of curative-intent treatment, assessed up to 2 years
2

Overall response rate (ORR) by mRECIST

Proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to mRECIST during study treatment and follow-up.

Time frame
Best overall response from the date of first treatment until radiographic disease progression, start of new anti-cancer therapy, death, withdrawal, or end of study, assessed up to 2 years
3

Overall response rate (ORR) by RECIST 1.1

Proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.1 during study treatment and follow-up.

Time frame
Best overall response from the date of first treatment until radiographic disease progression, start of new anti-cancer therapy, death, withdrawal, or end of study, assessed up to 2 years
4

Disease control rate (DCR) by mRECIST

Proportion of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) according to mRECIST during study treatment and follow-up.

Time frame
Best overall response from the date of first treatment until radiographic disease progression, start of new anti-cancer therapy, death, withdrawal, or end of study, assessed up to 2 years

Other outcomes

Sponsors and contacts

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

Tongji Hospital

Lead sponsor

Akesobio

Collaborator

Source ClinicalTrials.gov
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