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

Launched by SUN YAT-SEN UNIVERSITY · Sep 11, 2023

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ClinConnect Summary

This clinical trial is studying two different ways of combining treatments for patients with a type of liver cancer called hepatocellular carcinoma (HCC) who might still be able to have surgery. The researchers want to find out if giving all the treatments at the same time (called concurrent treatment) works better than giving them one after the other (called sequential treatment). The main goals are to see if the simultaneous approach can help more patients have surgery and live longer, while also checking if the sequential method can prevent some patients from getting too much treatment without losing the chance for surgery or survival.

To participate in this trial, patients need to be between the ages of 18 and 75 and diagnosed with HCC that falls within specific stages of the disease. They should not have had any prior treatments for this type of cancer and should have certain health criteria that doctors will evaluate. During the trial, participants will be randomly assigned to one of the two treatment groups, and researchers will compare the outcomes, such as the ability to undergo surgery and overall safety of the treatments. It’s important for patients to understand that they will be closely monitored throughout the study, and their health will be a top priority.

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Eligibility criteria

• 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.