Health Trials

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

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

Treatments tested in this trial

  • Oxaliplatin,calcium folinic acid, levofolinic acid, 5-FU
  • Concurrent Lenvatinib
  • Concurrent PD-1 antibody
  • Sequential Lenvatinib
  • Sequential PD-1 antibody

Treatment groups

540 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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