Comparing two treatment approaches for liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of two different treatment regimens for patients with potentially resectable intermediate and advanced hepatocellular carcinoma (HCC). Participants will be randomly assigned to receive either concurrent hepatic artery infusion chemotherapy (HAIC) combined with targeted and immunotherapy or sequential HAIC followed by the same therapies. The study will assess surgical conversion rates and overall survival benefits, with a focus on optimizing treatment based on individual patient responses. The trial involves multiple cycles of chemotherapy and careful monitoring of tumor responses to guide further treatment decisions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 and ≤75 years;
2. ECOG PS score of 0\~1;
3. 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;
4. Not having received previous treatment against hepatocellular carcinoma;
5. 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;
6. 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;
7. Patients were fully informed about the study and signed an informed consent form.

Exclusion Criteria:

1. 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;
2. Those with a history of other malignant tumors;
3. Those with a history of related drug allergy;
4. Those with known hypersensitivity to any component of the targeted and immunologic drugs to be applied;
5. Those with a history of organ transplantation;
6. Those who have received previous treatment targeting hepatocellular carcinoma (including interferon);
7. Those with co-infection with HIV;
8. Those with drugs abuse;
9. Those who have had gastrointestinal bleeding or cardiovascular events within the last 30 days;
10. Pregnant or breastfeeding women, or women of childbearing age who do not wish to use contraception;
11. Persons with concomitant psychiatric disorders that preclude informed consent or affect acceptance of treatment;
12. Other factors that may affect patient enrollment and assessment results.

Where it's running

• SUN Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Wei Wei, Ph.D, M,D — Sun Yat-sen University
• Study coordinator: Shao Hua Li, Ph.D, M,D
• Email: lishaoh@sysucc.org.cn
• Phone: 008615088064187

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.