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Concurrently vs Sequentially Combined HAIC With Targeted and Immunotherapy in Potentially Resectable HCC

ConditionsHepatocellular CarcinomaChemotherapy EffectChemotherapeutic Toxicity
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

The goal of this clinical trial is to compare HAIC concurrently with sequentially combined with targeted and immunotherapies in terms of efficacy and safety in patients with potentially resectable intermediate and advanced HCC (CNLC stage IIa\~IIIa). The main questions it aims to answer are:

* Does a "strong combination" regimen of three simultaneous treatments (HAIC, targeted agents and immunotherapy) definitely result in a higher surgical conversion rate and better survival benefit? * Can the combination of targeted and immunotherapies based on patients' response to HAIC therapy avoid over-treatment of some patients without affecting the surgical conversion rate and overall survival? Participants will be randomly assigned to receive either HAIC concurrently or sequentially combined with targeted and immunotherapies.

Researchers will compare concurrent treatment group with sequential treatment group to see if there are different in terms of the conversion resection rate, long-term survival, and safety.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 and ≤75 years;

ECOG PS score of 0~1;

Clinical or pathological diagnosis of hepatocellular carcinoma and meeting the stage IIa-IIIa of CNLC staging according to the relevant definitions in the 2015 edition of the Guidelines for Standardized Pathological Diagnosis of Primary Liver Cancer;

Not having received previous treatment against hepatocellular carcinoma;

Disqualifiers

Those with severe comorbidity including cardiac, cerebral, pulmonary, renal, and other vital organ function damage, combined with severe infections or other serious concomitant diseases (> grade 2 CTCAE Version 5.0 adverse events), who cannot tolerate the treatment;

Those with a history of other malignant tumors;

Those with a history of related drug allergy;

Those with known hypersensitivity to any component of the targeted and immunologic drugs to be applied;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oxaliplatin,calcium folinic acid, levofolinic acid, 5-FU

    Drug

    Hepatic arterial infusion chemotherapy with (oxaliplatin 135mg/m2 over 3hrs, calcium folinic acid 400mg/m2 or levofolinic acid 200mg/ m2 over 1.5hrs, 5-FU 400mg/m2 over 2hrs, 5-FU 2400mg/m2 over 46hrs,every 4 weeks)

  • Concurrent Lenvatinib

    Drug

    Lenvatinib 8mg/day combined with the HAIC from the first cycle

  • Concurrent PD-1 antibody

    Drug

    PD-1 antibody which is approved by authorities for HCC treatment combined with the HAIC from the first cycle (dosage and frequency according to instructions)

  • Sequential Lenvatinib

    Drug

    Lenvatinib 8mg/day combined with the HAIC from the third cycle for those patients who do not achieve complete response (CR)

  • Sequential PD-1 antibody

    Drug

    PD-1 antibody which is approved by authorities for HCC treatment combined with the HAIC from the third cycle for those patients who do not achieve complete response (CR) (dosage and frequency according to instructions)

Treatment groups

540 Participants
are divided into 2 treatment groups
Group A: concurrent treatment groupExperimental treatment 3 interventions
Group B: sequential treatment groupActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

OS

Overall survival of the participants

Time frame
From date of randomization until the date of death from any cause, assessed at least 36 months

Secondary outcomes

1

PFS

Progression-free survival of the participants

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed at least 36 months
2

ORR

Objective response rates, which means the proportion of patients with efficacy assessment of complete response and partial response for the size of intrahepatic target lesions according to mRECIST criteria and RECIST v1.1 criteria respectively.

Time frame
Assessed at the end of Cycle 2 and Cycle 4 (each cycle is 28 days)
3

DCR

Disease control rates, which means the proportion of patients with efficacy assessment of complete response, partial response and stable disease for the size of intrahepatic target lesions according to mRECIST criteria and RECIST v1.1 criteria respectively.

Time frame
Assessed at the end of Cycle 2 and Cycle 4 (each cycle is 28 days)
4

CRR

Conversion resection rate refer to the proportion of patients in both groups who actually underwent subsequent surgical resection.

Time frame
This outcome measure will be assessed at the end of Cycle 4 (each cycle is 28 days)

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Collaborator

Affiliated Hospital of Guangdong Medical University

Collaborator

First People's Hospital of Foshan

Collaborator

Source ClinicalTrials.gov
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