Status:
RECRUITING
Concurrently vs Sequentially Combined HAIC With Targeted and Immunotherapy in Potentially Resectable HCC
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Affiliated Hospital of Guangdong Medical University
Conditions:
Hepatocellular Carcinoma
Chemotherapy Effect
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 int...
Detailed Description
Participants in the concurrent treatment group will receive two cycles of HAIC (the drugs are oxaliplatin 135mg/m2 over 3hrs, calcium folinic acid 400mg/m2 or levofolinic acid 200mg/ m2 over 1.5hrs, 5...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2030
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT06041477
Start Date
October 31 2023
End Date
July 1 2030
Last Update
August 27 2024
Active Locations (1)
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1
SUN Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060