Sequential TransArterial Chemoembolization and Stereotactic RadioTherapy With ImmunoTherapy for Downstaging Hepatocellular Carcinoma for Hepatectomy

  • STATUS
    Recruiting
  • End date
    Feb 5, 2024
  • participants needed
    33
  • sponsor
    The University of Hong Kong
Updated on 23 January 2021
platelet count
systemic therapy
measurable disease
hepatitis
liver disease
cirrhosis
hepatitis b surface antigen
antiviral therapy
neutrophil count
TACE
stereotactic body radiation therapy
chemoembolization
antiviral drugs
hepatectomy

Summary

This study is a prospective phase II, single arm mono-institutional study conducted in Queen Mary Hospital (Hong Kong) assessing the efficacy and safety of the sequential administration of trans-arterial chemo-embolization (TACE) and stereotactic body radiotherapy (SBRT) with an immune checkpoint inhibitor in hepatocellular carcinoma (HCC) patients.

Description

All the patients must be registered with the Investigator(s) prior to initiation of treatment. The registration desk will confirm all eligibility criteria and obtain essential information (including patient number).

TACE should start within 28 days of study registration and its procedure will be standardised.

SBRT screening and planning will be performed by radiation therapists, medical physicists, and oncologists.

Details
Condition HEPATOCELLULAR CARCINOMA, liver cell carcinoma
Treatment TACE, SBRT, Immune checkpoint inhibitor
Clinical Study IdentifierNCT03817736
SponsorThe University of Hong Kong
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of HCC confirmed pathologically or made according to American Association for the Study of Liver Diseases (AASLD) practice guideline 2010: patients with cirrhosis of any etiology and patients with chronic hepatitis B (HBV) who may not have fully developed cirrhosis, the presence of liver nodule >1cm and demonstrated in a single contrast-enhanced dynamic imaging [magnetic resonance imaging (MRI)] of intense arterial uptake and "washout" in portal venous and delayed phases
Male or female subjects with age: 18-75 years old
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Tumor size 5-15cm or number of lesions 3 or segmental portal vein involvement
Child-Pugh liver function class A-B7
Liver volume minus intrahepatic GTV >700 cc
Minimal distance from GTV to stomach, duodenum, small or large bowel >1 cm
No prior systemic therapy nor immunotherapy
No prior trans-arterial chemo-embolization (TACE)
No prior radiotherapy to the liver or selective internal radiation (SIRT)
Written informed consent obtained for clinical trial participation and providing archival tumor tissue, if available
Subjects with confirmed concomitant HBV infection (defined as HBsAg positive or HBV DNA detectable) that are eligible for inclusion must be treated with antiviral therapy (per local institutional practice) prior to enrollment to ensure adequate viral suppression (HBV DNA <2000 IU/mL), must remain on antiviral therapy for the study duration, and continue therapy for 6 months after the last dose of investigational product(s)
At least one measurable lesion according to RECIST v1.1
Adequate organ and marrow function, as defined below
Hemoglobin 9 g/dL
Absolute neutrophil count 1,500/L
Platelet count 100,000/L
Total bilirubin 2.0 ULN
ALT 3 ULN
Albumin 2.8 g/dL
INR 1.6
Calculated creatinine clearance 45 mL/minute as determined by Cockcroft-Gault (using actual body weight) or 24-hour urine creatinine clearance
Females of childbearing potential or non-sterilized male who are sexually active must use a highly effective method of contraception
Females of childbearing potential must have negative serum or urine pregnancy test

Exclusion Criteria

Prior invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, lobular or ductal carcinoma in situ of the breast that has been surgically cured
Contraindicated of SBRT: Any one hepatocellular carcinoma >15 cm; Total maximal sum of hepatocellular carcinoma >20 cm; More than 3 discrete hepatic nodule; Direct tumor extension into the stomach, duodenum, small bowel, large bowel, common or main branch of biliary tree
Severe, active co-morbidity
Presence of extra-hepatic metastases (M1)
Left portal vein, right portal vein, main portal vein or inferior vena cava (IVC) thrombosis or involvement
Presence of clinically meaningful ascites as ascites requiring non pharmacologic intervention (eg, paracentesis) or escalation in pharmacologic intervention to maintain symptomatic control
Hepatic encephalopathy
Active or untreated gastrointestinal varices
Untreated central nervous system (CNS) metastatic disease, lepto-meningeal disease, or cord compression
Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke ( <6 months prior to enrollment), myocardial infarction ( <6 months prior to enrollment), unstable angina, congestive heart failure (>= New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
Prior treatment with any immune checkpoint inhibitors or an antibody targeting immuno-regulatory receptors or mechanisms
Irritable bowel syndrome or other serious gastrointestinal chronic conditions associated with diarrhea within the past 3 years prior to the start of treatment
Known history of testing positive for HIV or known acquired immunodeficiency syndrome
On chronic systemic steroid or any other forms of immunosuppressive medication within 14 days prior to the treatment. Except
intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
Systemic corticosteroids at physiologic doses <=10 mg/day of prednisone or equivalent
Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
Active or prior documented autoimmune or inflammatory disorders in the past 2 years, except diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment
History of primary immunodeficiency or solid organ transplantation
Receipt of live, attenuated vaccine within 28 days prior to the study treatment
Active infection requiring systemic therapy
Severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
Females who are pregnant, lactating, or intend to become pregnant during their participation in the study
Psychiatric disorders and substance (drug/alcohol) abuse
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