Sequential TACE and SBRT Followed by ImmunoTherapy for Downstaging HCC for Hepatectomy
NCT ID: NCT03817736
Last Updated: 2024-05-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
33 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-03-01
Study Completion Date
2023-07-26
Brief Summary
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This study is a prospective phase II, single arm clinical 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.
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Immune Checkpoint Inhibitors and Anti-vascular Endothelial Growth Factor Antibody/tyrosine Kinase Inhibitors with or Without TACE for Advanced HCC with Vascular Invasions
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Detailed Description
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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.
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.
Conditions
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HCC
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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START-FIT
Single group assignment combining TACE and SBRT with immune checkpoint inhibitor as treatment in HCC patients.
Procedure of TACE will be standardized.
SBRT screening and planning will be performed by radiation therapists, medical physicists, and oncologists.
An immune checkpoint inhibitor may be administered up to 3 days before or after the scheduled day of administration of each cycle due to administrative reasons.
Group Type
EXPERIMENTAL
TACE
Intervention Type
PROCEDURE
Procedure of TACE will be standardized.
SBRT
Intervention Type
RADIATION
SBRT screening and planning will be performed by radiation therapists, medical physicists, and oncologists.
Immune Checkpoint Inhibitor
Intervention Type
DRUG
An immune checkpoint inhibitor may be administered up to 3 days before or after the scheduled day of administration of each cycle due to administrative reasons.
Interventions
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TACE
Procedure of TACE will be standardized.
Intervention Type
PROCEDURE
SBRT
SBRT screening and planning will be performed by radiation therapists, medical physicists, and oncologists.
Intervention Type
RADIATION
Immune Checkpoint Inhibitor
An immune checkpoint inhibitor may be administered up to 3 days before or after the scheduled day of administration of each cycle due to administrative reasons.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. 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.
2. Male or female subjects with age: 18-75 years old
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
4. Tumor size 5-15cm or number of lesions ≤3 or segmental portal vein involvement
5. Child-Pugh liver function class A-B7
6. Liver volume minus intrahepatic GTV \>700 cc.
7. Minimal distance from GTV to stomach, duodenum, small or large bowel \>1 cm.
8. No prior systemic therapy nor immunotherapy
9. No prior trans-arterial chemo-embolization (TACE)
10. No prior radiotherapy to the liver or selective internal radiation (SIRT)
11. Written informed consent obtained for clinical trial participation and providing archival tumor tissue, if available.
12. 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)
13. At least one measurable lesion according to RECIST v1.1.
14. Adequate organ and marrow function, as defined below:
* Hemoglobin ≥9 g/dL
* Absolute neutrophil count ≥1,500/μL
* Platelet count ≥100,000/μL
* 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
15. Females of childbearing potential or non-sterilized male who are sexually active must use a highly effective method of contraception
16. Females of childbearing potential must have negative serum or urine pregnancy test
2. Male or female subjects with age: 18-75 years old
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
4. Tumor size 5-15cm or number of lesions ≤3 or segmental portal vein involvement
5. Child-Pugh liver function class A-B7
6. Liver volume minus intrahepatic GTV \>700 cc.
7. Minimal distance from GTV to stomach, duodenum, small or large bowel \>1 cm.
8. No prior systemic therapy nor immunotherapy
9. No prior trans-arterial chemo-embolization (TACE)
10. No prior radiotherapy to the liver or selective internal radiation (SIRT)
11. Written informed consent obtained for clinical trial participation and providing archival tumor tissue, if available.
12. 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)
13. At least one measurable lesion according to RECIST v1.1.
14. Adequate organ and marrow function, as defined below:
* Hemoglobin ≥9 g/dL
* Absolute neutrophil count ≥1,500/μL
* Platelet count ≥100,000/μL
* 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
15. Females of childbearing potential or non-sterilized male who are sexually active must use a highly effective method of contraception
16. Females of childbearing potential must have negative serum or urine pregnancy test
Exclusion Criteria
1. 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
2. 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
3. Severe, active co-morbidity
4. Presence of extra-hepatic metastases (M1)
5. Left portal vein, right portal vein, main portal vein or inferior vena cava (IVC) thrombosis or involvement
6. Presence of clinically meaningful ascites as ascites requiring non pharmacologic intervention (eg, paracentesis) or escalation in pharmacologic intervention to maintain symptomatic control
7. Hepatic encephalopathy
8. Active or untreated gastrointestinal varices
9. Untreated central nervous system (CNS) metastatic disease, lepto-meningeal disease, or cord compression
10. 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.
11. Prior treatment with any immune checkpoint inhibitors or an antibody targeting immuno-regulatory receptors or mechanisms
12. Irritable bowel syndrome or other serious gastrointestinal chronic conditions associated with diarrhea within the past 3 years prior to the start of treatment
13. Known history of testing positive for HIV or known acquired immunodeficiency syndrome.
14. On chronic systemic steroid or any other forms of immunosuppressive medication within 14 days prior to the treatment. Except:
1. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection);
2. Systemic corticosteroids at physiologic doses \<=10 mg/day of prednisone or equivalent;
3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
15. 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
16. History of primary immunodeficiency or solid organ transplantation
17. Receipt of live, attenuated vaccine within 28 days prior to the study treatment
18. Active infection requiring systemic therapy
19. Severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
20. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study
21. Psychiatric disorders and substance (drug/alcohol) abuse
2. 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
3. Severe, active co-morbidity
4. Presence of extra-hepatic metastases (M1)
5. Left portal vein, right portal vein, main portal vein or inferior vena cava (IVC) thrombosis or involvement
6. Presence of clinically meaningful ascites as ascites requiring non pharmacologic intervention (eg, paracentesis) or escalation in pharmacologic intervention to maintain symptomatic control
7. Hepatic encephalopathy
8. Active or untreated gastrointestinal varices
9. Untreated central nervous system (CNS) metastatic disease, lepto-meningeal disease, or cord compression
10. 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.
11. Prior treatment with any immune checkpoint inhibitors or an antibody targeting immuno-regulatory receptors or mechanisms
12. Irritable bowel syndrome or other serious gastrointestinal chronic conditions associated with diarrhea within the past 3 years prior to the start of treatment
13. Known history of testing positive for HIV or known acquired immunodeficiency syndrome.
14. On chronic systemic steroid or any other forms of immunosuppressive medication within 14 days prior to the treatment. Except:
1. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection);
2. Systemic corticosteroids at physiologic doses \<=10 mg/day of prednisone or equivalent;
3. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
15. 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
16. History of primary immunodeficiency or solid organ transplantation
17. Receipt of live, attenuated vaccine within 28 days prior to the study treatment
18. Active infection requiring systemic therapy
19. Severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
20. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study
21. Psychiatric disorders and substance (drug/alcohol) abuse
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Sponsor Role
collaborator
The University of Hong Kong
OTHER
Sponsor Role
lead
Responsible Party
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Dr. Chi-Leung Chiang
Clinical Assistant Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Chi Leung Chiang, Chiang
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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Department of Clinical Oncology
Hong Kong, , Hong Kong
Site Status
Countries
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Hong Kong
References
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Lo CM, Ngan H, Tso WK, Liu CL, Lam CM, Poon RT, Fan ST, Wong J. Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma. Hepatology. 2002 May;35(5):1164-71. doi: 10.1053/jhep.2002.33156.
Reference Type
BACKGROUND
Llovet JM, Real MI, Montana X, Planas R, Coll S, Aponte J, Ayuso C, Sala M, Muchart J, Sola R, Rodes J, Bruix J; Barcelona Liver Cancer Group. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1734-9. doi: 10.1016/S0140-6736(02)08649-X.
Reference Type
BACKGROUND
Shim SJ, Seong J, Han KH, Chon CY, Suh CO, Lee JT. Local radiotherapy as a complement to incomplete transcatheter arterial chemoembolization in locally advanced hepatocellular carcinoma. Liver Int. 2005 Dec;25(6):1189-96. doi: 10.1111/j.1478-3231.2005.01170.x.
Reference Type
BACKGROUND
Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.
Reference Type
BACKGROUND
Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. doi: 10.1016/S1470-2045(08)70285-7. Epub 2008 Dec 16.
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BACKGROUND
Blomgren H, Lax I, Naslund I, Svanstrom R. Stereotactic high dose fraction radiation therapy of extracranial tumors using an accelerator. Clinical experience of the first thirty-one patients. Acta Oncol. 1995;34(6):861-70. doi: 10.3109/02841869509127197.
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BACKGROUND
Cardenes HR, Price TR, Perkins SM, Maluccio M, Kwo P, Breen TE, Henderson MA, Schefter TE, Tudor K, Deluca J, Johnstone PA. Phase I feasibility trial of stereotactic body radiation therapy for primary hepatocellular carcinoma. Clin Transl Oncol. 2010 Mar;12(3):218-25. doi: 10.1007/s12094-010-0492-x.
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BACKGROUND
Andolino DL, Johnson CS, Maluccio M, Kwo P, Tector AJ, Zook J, Johnstone PA, Cardenes HR. Stereotactic body radiotherapy for primary hepatocellular carcinoma. Int J Radiat Oncol Biol Phys. 2011 Nov 15;81(4):e447-53. doi: 10.1016/j.ijrobp.2011.04.011. Epub 2011 Jun 7.
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BACKGROUND
Kang JK, Kim MS, Cho CK, Yang KM, Yoo HJ, Kim JH, Bae SH, Jung DH, Kim KB, Lee DH, Han CJ, Kim J, Park SC, Kim YH. Stereotactic body radiation therapy for inoperable hepatocellular carcinoma as a local salvage treatment after incomplete transarterial chemoembolization. Cancer. 2012 Nov 1;118(21):5424-31. doi: 10.1002/cncr.27533. Epub 2012 May 8.
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BACKGROUND
Bujold A, Massey CA, Kim JJ, Brierley J, Cho C, Wong RK, Dinniwell RE, Kassam Z, Ringash J, Cummings B, Sykes J, Sherman M, Knox JJ, Dawson LA. Sequential phase I and II trials of stereotactic body radiotherapy for locally advanced hepatocellular carcinoma. J Clin Oncol. 2013 May 1;31(13):1631-9. doi: 10.1200/JCO.2012.44.1659. Epub 2013 Apr 1.
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BACKGROUND
Radiation Therapy Oncology Group RTOG 1112 protocol. Available from: https://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?study=1112.
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BACKGROUND
Huo YR, Eslick GD. Transcatheter Arterial Chemoembolization Plus Radiotherapy Compared With Chemoembolization Alone for Hepatocellular Carcinoma: A Systematic Review and Meta-analysis. JAMA Oncol. 2015 Sep;1(6):756-65. doi: 10.1001/jamaoncol.2015.2189.
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BACKGROUND
Hawkins MA, Dawson LA. Radiation therapy for hepatocellular carcinoma: from palliation to cure. Cancer. 2006 Apr 15;106(8):1653-63. doi: 10.1002/cncr.21811.
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BACKGROUND
Chiang CL, Chan MKH, Yeung CSY, Ho CHM, Lee FAS, Lee VWY, Wong FCS, Blanck O. Combined stereotactic body radiotherapy and trans-arterial chemoembolization as initial treatment in BCLC stage B-C hepatocellular carcinoma. Strahlenther Onkol. 2019 Mar;195(3):254-264. doi: 10.1007/s00066-018-1391-2. Epub 2018 Nov 9.
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BACKGROUND
Gehring AJ, Ho ZZ, Tan AT, Aung MO, Lee KH, Tan KC, Lim SG, Bertoletti A. Profile of tumor antigen-specific CD8 T cells in patients with hepatitis B virus-related hepatocellular carcinoma. Gastroenterology. 2009 Aug;137(2):682-90. doi: 10.1053/j.gastro.2009.04.045. Epub 2009 Apr 23.
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BACKGROUND
Bernstein MB, Krishnan S, Hodge JW, Chang JY. Immunotherapy and stereotactic ablative radiotherapy (ISABR): a curative approach? Nat Rev Clin Oncol. 2016 Aug;13(8):516-24. doi: 10.1038/nrclinonc.2016.30. Epub 2016 Mar 8.
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BACKGROUND
Postow MA, Callahan MK, Barker CA, Yamada Y, Yuan J, Kitano S, Mu Z, Rasalan T, Adamow M, Ritter E, Sedrak C, Jungbluth AA, Chua R, Yang AS, Roman RA, Rosner S, Benson B, Allison JP, Lesokhin AM, Gnjatic S, Wolchok JD. Immunologic correlates of the abscopal effect in a patient with melanoma. N Engl J Med. 2012 Mar 8;366(10):925-31. doi: 10.1056/NEJMoa1112824.
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BACKGROUND
Chiang CL, Chiu KWH, Chan KSK, Lee FAS, Li JCB, Wan CWS, Dai WC, Lam TC, Chen W, Wong NSM, Cheung ALY, Lee VWY, Lau VWH, El Helali A, Man K, Kong FMS, Lo CM, Chan AC. Sequential transarterial chemoembolisation and stereotactic body radiotherapy followed by immunotherapy as conversion therapy for patients with locally advanced, unresectable hepatocellular carcinoma (START-FIT): a single-arm, phase 2 trial. Lancet Gastroenterol Hepatol. 2023 Feb;8(2):169-178. doi: 10.1016/S2468-1253(22)00339-9. Epub 2022 Dec 15.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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UW 18-541
Identifier Type: -
Identifier Source: org_study_id
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