Anlotinib Hydrochloride In Combination With Radiofrequency Ablation And Transcatheter Arterial Chemoembolization in Patients With Middle-advanced Hepatocellular Carcinoma, Open, Single Arm, Exploratory Clinical Trial

Jinglong Chen3 sites in 1 country48 target enrollmentNovember 28, 2019

ConditionsHepatocellular Carcinoma

InterventionsAnlotinib TACE+RFA

DrugsAnlotinib

Overview

Phase: Phase 2
Intervention: Anlotinib
Conditions: Hepatocellular Carcinoma
Sponsor: Jinglong Chen
Enrollment: 48
Locations: 3
Primary Endpoint: Time To Progression(TTP)
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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)

Registry

clinicaltrials.gov

Start Date

November 28, 2019

End Date

March 30, 2023

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jinglong Chen

Responsible Party

Sponsor Investigator

Principal Investigator

Jinglong Chen

Chief of Oncology

Beijing Ditan Hospital

Eligibility Criteria

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
•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) ≥ 1.5×109/L, leucocyte (WBC) ≥ 3.0×109/L, Platelet count (PLT) ≥ 70×109/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.

Arms & Interventions

Anlotinib+ TACE+ RFA

Intervention: Anlotinib

Anlotinib+ TACE+ RFA

Intervention: TACE+RFA

Outcomes

Primary Outcomes

Time To Progression(TTP)

Time Frame: each 42 days up to progressive disease (PD) (up to 24 months)

Time To Progression is defined as the time from first day of TACE treatment until the first date of either objective disease progression

Secondary Outcomes

Objective Response Rate (ORR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))
Duration of Response (DOR)(Time Frame: each 42 days up to intolerance the PD or death (up to 24 months))
Incidence of Treatment-Emergent Adverse Events(Until 30 day safety follow-up visit)
Disease Control Rate (DCR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))