Status:
COMPLETED
A Single Center Study of Donafenib Combined With PD-1 + TACE in the First-line Treatment of aHCC
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Donafenib
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is expected to recruit 30 patients with unresectable HCC who will be treated with Donafenib combined with PD-1 + TACE. During the study period, the tumor efficacy and resectability will be ...
Eligibility Criteria
Inclusion
- Patients voluntarily enter the study and sign informed consent form (ICF);
- Age ≥ 18 years and ≤ 75 years, and there is no limit on the gender;
- Clinically or histologically diagnosed as unresectable HCC;
- There is at least one measurable lesions that meet the mRECIST standard;
- Child-pugh classification A or B (score≤7);
- ECOG : 0 \~ 1 ;
- The number of intrahepatic tumors ≤ 10 and the maximum tumor diameter ≤ 10cm;
- Previous TACE treatment ≤ 1 time;
- Life expectancy ≥ 3 months;
- For patients with HBV infection, if HBV-DNA is≥10\^4copies/ml within 14 days before enrollment, they should take antiviral treatment first, reduce 1 log or reduce to \<10\^4copies/ml before entering the study, and continue antiviral treatment and monitor liver function and serum HBV-DNA levels;
- Baseline blood routine and biochemical indexes meet the following criteria within 14 days before treatment:
- Blood routine examination criteria must be met: (no blood transfusion within 14 days)
- HB≥90g/L；
- ANC≥1.5×10\^9/L；
- PLT≥70×10\^9/L.
- Biochemical tests are subject to the following criteria:
- BIL \<1.25xULN ；
- ALT and AST\<5xULN；
- Serum creatinine. Less than 1.5 times the upper limit of normal value, Endogenous creatinine clearance\>50ml/min ( Cockcroft-Gault formula)；
- Albumin≥28g/L；
- Electrolytes (phosphorus, calcium, magnesium, potassium) ≥ LLN;
- Urine protein \<2+ or 24-hour urine protein quantitative detection ≤1.0 g/L.
- Blood coagulation indexes are subject to the following criteria:
- Prothrombin time (PT) and international normalized ratio (INR) ≤1.5 × ULN;
- Activated partial thromboplastin time（APTT）≤1.5 × ULN.
- The serum pregnancy test results of female patients with fertility (referring to premenopausal or non surgical sterilization) must be negative within 14 days before enrollment.
Exclusion
- Pathologically confirmed hepatocellular carcinoma intrahepatic cholangiocarcinoma (HCC-ICC) mixed or fibrolamellar hepatocellular carcinoma;
- The presence of a tumor thrombus in the main portal vein, biliary tract tumor thrombus, inferior vena cava tumor thrombus, or extrahepatic metastasis;
- Hepatocellular carcinoma recurrence within 2 years after radical resection or ablation;
- History of malignancy other than HCC within 5 years;
- Esophageal and/or gastric varices bleeding within 4 weeks prior to initiation of study treatment;
- Presence of uncontrolled hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion, or pericardial effusion;
- Patients who received liver transplant surgery, prior systemic therapy (chemotherapy, targeted therapy or immunotherapy) or palliative local treatment ≥2 times for HCC；
- History of organ and cell transplantation；
- TACE contraindications identified by the investigator;
- Active severe infection;
- Autoimmune disease or immune deficiency;
- Severe organ (heart, kidney) dysfunction;
- Pregnant or breastfeeding women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures;
- Unable to follow the research protocol for treatment or scheduled follow-up; Any other researcher who thinks they cannot be included.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05262959
Start Date
December 1 2021
End Date
May 30 2024
Last Update
August 13 2024
Active Locations (1)
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1
Zhongshan Hospital, Fudan University,
Shanghai, Shanghai Municipality, China, 200032