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

Phase 3

Recruiting

• Conditions: Hepatocellular Carcinoma; Chemotherapy Effect; Chemotherapeutic Toxicity

• Registration Number: NCT06041477
• Lead Sponsor: Sun Yat-sen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-7-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Age =18 and =75 years;<br><br> 2. ECOG PS score of 0~1;<br><br> 3. Clinical or pathological diagnosis of hepatocellular carcinoma and meeting the stage<br> IIa-IIIa of CNLC staging according to the relevant definitions in the 2015 edition<br> of the Guidelines for Standardized Pathological Diagnosis of Primary Liver Cancer;<br><br> 4. Not having received previous treatment against hepatocellular carcinoma;<br><br> 5. Those who cannot be surgically resected after discussion by the multidisciplinary<br> team of the participating centers , but have a potential chance of resection after<br> conversion therapy, including: multiple tumors located in one lobe of the liver;<br> portal vein cancer thrombus not reaching the main trunk, which can be resected<br> together with the primary focus;<br><br> 6. Laboratory tests meet the following conditions, or the following conditions can be<br> achieved with short-term treatment:<br><br> Neutrophil count =2.0×109/L; Hemoglobin = 100 g/L; Platelet count = 75 × 109/L;<br> Plasma albumin level = 35 g/L; Plasma total bilirubin less than 2 times the upper<br> limit of normal; Plasma alanine aminotransferase (ALT) less than 3 times the upper<br> limit of normal; Plasma aspartate aminotransferase (AST) less than 3 times the upper<br> limit of normal; Plasma creatinine less than 1.5 times the upper limit of normal;<br> Plasma prothrombin time is normal or exceeds the upper limit of normal value by = 4<br> seconds; Prothrombinogen international normalized ratio (INR) = 2.2;<br><br> 7. Patients were fully informed about the study and signed an informed consent form.<br><br>Exclusion Criteria:<br><br> 1. Those with severe comorbidity including cardiac, cerebral, pulmonary, renal, and<br> other vital organ function damage, combined with severe infections or other serious<br> concomitant diseases (> grade 2 CTCAE Version 5.0 adverse events), who cannot<br> tolerate the treatment;<br><br> 2. Those with a history of other malignant tumors;<br><br> 3. Those with a history of related drug allergy;<br><br> 4. Those with known hypersensitivity to any component of the targeted and immunologic<br> drugs to be applied;<br><br> 5. Those with a history of organ transplantation;<br><br> 6. Those who have received previous treatment targeting hepatocellular carcinoma<br> (including interferon);<br><br> 7. Those with co-infection with HIV;<br><br> 8. Those with drugs abuse;<br><br> 9. Those who have had gastrointestinal bleeding or cardiovascular events within the<br> last 30 days;<br><br> 10. Pregnant or breastfeeding women, or women of childbearing age who do not wish to use<br> contraception;<br><br> 11. Persons with concomitant psychiatric disorders that preclude informed consent or<br> affect acceptance of treatment;<br><br> 12. Other factors that may affect patient enrollment and assessment results.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OS

Secondary Outcome Measures

Name	Time	Method
PFS;ORR;DCR;CRR;Safety profiles of all participants