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

Recruiting now · Phase 3

Conditions studied: Hepatocellular Carcinoma, Chemotherapy Effect, Chemotherapeutic Toxicity

In brief

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.

Key facts

Study ID: NCT06041477
Run by: Sun Yat-sen University
People needed: 540
Starts: 2023-10-31
Expected to finish: 2030-07-01
Last updated by the study team: 2024-08-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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;
Those who cannot be surgically resected after discussion by the multidisciplinary team of the participating centers , but have a potential chance of resection after conversion therapy, including: multiple tumors located in one lobe of the liver; portal vein cancer thrombus not reaching the main trunk, which can be resected together with the primary focus;
Laboratory tests meet the following conditions, or the following conditions can be achieved with short-term treatment:
Neutrophil count ≥2.0×109/L; Hemoglobin ≥ 100 g/L; Platelet count ≥ 75 × 109/L; Plasma albumin level ≥ 35 g/L; Plasma total bilirubin less than 2 times the upper limit of normal; Plasma alanine aminotransferase (ALT) less than 3 times the upper limit of normal; Plasma aspartate aminotransferase (AST) less than 3 times the upper limit of normal; Plasma creatinine less than 1.5 times the upper limit of normal; Plasma prothrombin time is normal or exceeds the upper limit of normal value by ≤ 4 seconds; Prothrombinogen international normalized ratio (INR) ≤ 2.2;
Patients were fully informed about the study and signed an informed consent form.

You may not qualify if…

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;
Those with a history of organ transplantation;
Those who have received previous treatment targeting hepatocellular carcinoma (including interferon);
Those with co-infection with HIV;
Those with drugs abuse;
Those who have had gastrointestinal bleeding or cardiovascular events within the last 30 days;
Pregnant or breastfeeding women, or women of childbearing age who do not wish to use contraception;
Persons with concomitant psychiatric disorders that preclude informed consent or affect acceptance of treatment;
Other factors that may affect patient enrollment and assessment results.

Where it is running

SUN Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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