Anlotinib In Combination With RFA And TACE in Patients With Middle-advanced HCC

  • STATUS
    Recruiting
  • End date
    Mar 30, 2023
  • participants needed
    48
  • sponsor
    Jinglong Chen
Updated on 20 February 2022
ct scan
platelet count
liver cancer
cancer
measurable disease
neutrophil count
cabozantinib
TACE
radiofrequency ablation
sorafenib
chemoembolization
lenvatinib
angiogenesis inhibitor
regorafenib
transcatheter arterial chemoembolisation

Summary

A single-arm, open-label clinical trial, focus on the safety and efficacy of anlotinib hydrochloride in combination with radiofrequency ablation (RFA) and transcatheter arterial chemoembolization(TACE) in patients with middle-advanced hepatocellular carcinoma(HCC)

Details
Condition Hepatocellular Carcinoma
Treatment Anlotinib, TACE+RFA
Clinical Study IdentifierNCT04157140
SponsorJinglong Chen
Last Modified on20 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients participate in the study voluntarily and sign informed consent with good compliance
Histological or cytological confirmation of unrespectable middle-advanced hepatocellular carcinoma, Barcelona Clinic Liver Cancer stage Category C or B , liver function child-Pugh class A or B (7 points)
At least one measurable lesion, with diameter 10mm measured by spiral MRI/CT scan per mRECIST; have not received local therapies including but not limited to TACE, RFA, radiotherapy and cryosurgery.-Eastern Cooperative Oncology Group Performance Status 0 or 1
Life expectancy of at least 3 months
Main organs function is normal. (normal main organs function as defined below: Hemoglobin (Hb) 90 g/L, Neutrophils (ANC) 1.5109/L, leucocyte (WBC) 3.0109/L, Platelet count (PLT) 70109/L, Total bilirubin (TBIL) 1.5 normal upper limit (ULN), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) 2.5 ULN, Serum creatinine (Cr) 1.5 ULN or Creatinine Clearance rate(CCr) 60ml/min,Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) > 50%)
The woman patients of childbearing age who must agree to take contraceptive methods (e.g. intrauterine device, contraceptive pill or condom) during the research and within another 3 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; The man patients who must agree to take contraceptive methods during the research and within another 8 weeks after it
Patients have disease that is not amenable to potentially curative transplantation or ablation
Patients who have characterization for targeted therapy treatment, but under poor economic conditions and cannot afford angiogenesis inhibitors recommended by current guidelines, including Lenvatinib, sorafenib, Cabozantinib, Ramolumab, regorafenib, etc

Exclusion Criteria

History of other malignancy within 5 years or for now (except for non-melanoma skin cancer, cervix in situ carcinoma, superficial Bladder neoplasms)
Subject has obstacle in the function of major organs such as heart, lung, liver and kidney
Patients who plan liver transplantation
Patients who had previously received treatment with target inhibitors or other immunotherapy against or chemotherapy
Patients who had previously received treatment with TACE or or other local therapy or radiotherapy or Chinese medicine treatment within 4 weeks
Liver function status Child-Pugh Class C, with malignant ascites
Participated in other anti-tumor clinical trials within 4 weeks
Symptoms that affect oral medication and cannot be controlled through proper treatment (such as inability to swallow, chronic diarrhoea and intestinal obstruction, etc.)
Any of the following coagulation functions are abnormal, including: Prothrombin time (PT)>ULN+4s, Activated partial thromboplastin time (APTT) >1.5ULN s, nternational normalized ratio (INR)>1.5
Patients who underwent major surgery within 4 weeks
Patients who have got non remissive toxic reactions derived from any treatment, which is over level 1 in CTC AE (4.0)
Patients with any severe and/or unable to control diseasesincluding Patients with unsatisfactory blood pressure control using antihypertensive drugs (systolic blood pressure 150 mmHg or diastolic blood pressure 100) mmHg); Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc480ms) and patients with Grade 2 or higher congestive heart failure (NYHA Classification); Patients with active or unable to control serious infections, which is over level 2 in CTC AE (4.0); Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L); Patients with kidney failure who require hemodialysis or peritoneal dialysis; Patients with a history of immunodeficiency, including a positive HIV test or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; Urine routine indicates that urine protein ++, and confirmed 24-hour urine protein quantitation > 1.0 g
Patients whose tumors had invaded important blood vessels by imaging or who, as determined by the researchers, were likely to invade important blood vessels during follow-up trial, resulting in fatal bleeding
Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism
Regardless of the severity, patients with any physical signs or history of bleeding, patients with bleeding or bleeding events greater than or equal to CTCAE 3 within four weeks prior to the first administration, or patients with unhealed wounds, fractures, ulcers
Patients with Brain metastases
Patients with cancer thrombus involving whole the main portal vein
Female patients who are pregnant or breastfeeding
Patients with drug abuse history and unable to get rid of or patients with mental disorders
Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
History of gastrointestinal bleeding due to severe gastroesophageal varices within 4 weeks
Severe active or uncontrolled infections
Patients who had serious adverse effect to Anlotinib
Patients who had serious adverse effect to iodinated contrast agent
Liver cirrhosis, hepatic decompensation, active hepatitis or chronic hepatitis which requires anti-viral treatment. Hepatitis C virus (HCV) antibody test shows positive and titer test shows amount of HCV exceeds upper limit of normal (ULN) after treatment
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