Atezolizumab and BEvacizumab With STereotactic Body Radiotherapy for Advanced Hepatocellular Carcinoma

NCT06595108 | Recruiting

• 1 other identifier: 09-2024-0026
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy and safety of atezolizumab-bevacizumab combination therapy plus stereotactic body radiotherapy(SBRT) in patients with advanced hepatocellular carcinoma, Subjects will start SBRT for one or more primary cancers and/or metastatic lesions and no more than 5 sites within two month before and after the start date of atezolizumab-bevacizumab combination therapy. In this study, it is expected to improve the treatment response rate of atezolizumab-bevacizumab therapy, which is currently first-line chemotherapy but has a low treatment response rate.

Conditions

Advanced Hepatocellular Carcinoma; Chemotherapy; Stereotactic Body Radiotherapy

Keywords

atezolizumab-bevacizumab; SBRT

Outcome Measures

Primary Outcomes (1)

• Progression-free survival at 6 month

  The primary endpoint is to improve 6-month progression-free survival rate in the treatment group compared to those existing literature. Progression-free survival and overall survival are evaluated using the Kaplan-Meier curve. Verified through one sample proportion test.

  6 months after registration

Secondary Outcomes (4)

• Overall survival

  36 months after registration

• Objective response rate

  36 months after registration

• Adverse event (Toxicity)

  36 months after registration

• Tumor marker response: AFP, PIVKA-II

  36 months after registration

Study Arms (1)

Patients with advanced hepatocellular carcinoma

EXPERIMENTAL

Patients indicated for the first-line atezolizumab-bevacizumab combination therapy are the primary subjects, and those voluntarily agree to the clinical trial after explanation of the study, are enrolled in the study.

Radiation: Stereotactic body radiotherapy

Interventions

Stereotactic body radiotherapy RADIATION

Patients with advanced hepatocellular carcinoma who are indicated for the first-line atezolizumab-bevacizumab combination therapy are the primary subjects, and they should begin stereotactic radiotherapy to one or more but not more than five sites for primary cancer and/or metastatic lesions within two month before and after the start date of atezolizumab-bevacizumab combination therapy.

Patients with advanced hepatocellular carcinoma

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19 to 80 years old
• Liver function Child-Pugh class A
• ECOG 0-1
• Patient clinically or pathologically diagnosed with hepatocellular carcinoma
• Advanced hepatocellular carcinoma that is inoperable
• Satisfies the dose limits for normal organs and lesions of an appropriate size to be included in the scope of radiotherapy.

You may not qualify if:

• Brain metastases
• Have a history of malignancy other than hepatocellular carcinoma within the last 5 years (except for malignancies with little risk of metastasis or death, e.g., adequately treated cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, tubular carcinoma in situ, or stage 1 uterine cancer.)
• Subjects with a high probability of untreated gastric or esophageal varices or bleeding
• Serious uncontrolled medical comorbidities
• History of liver transplant surgery
• Autoimmune liver disease

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yongin Severance Hospital

Yongin-si, 365, South Korea

RECRUITING

Related Publications (8)

• Meng L, Xu J, Ye Y, Wang Y, Luo S, Gong X. The Combination of Radiotherapy With Immunotherapy and Potential Predictive Biomarkers for Treatment of Non-Small Cell Lung Cancer Patients. Front Immunol. 2021 Sep 21;12:723609. doi: 10.3389/fimmu.2021.723609. eCollection 2021.

  PMID: 34621270 BACKGROUND

• Demaria S, Golden EB, Formenti SC. Role of Local Radiation Therapy in Cancer Immunotherapy. JAMA Oncol. 2015 Dec;1(9):1325-32. doi: 10.1001/jamaoncol.2015.2756.

  PMID: 26270858 BACKGROUND

• Demaria S, Guha C, Schoenfeld J, Morris Z, Monjazeb A, Sikora A, Crittenden M, Shiao S, Khleif S, Gupta S, Formenti SC, Vikram B, Coleman CN, Ahmed MM. Radiation dose and fraction in immunotherapy: one-size regimen does not fit all settings, so how does one choose? J Immunother Cancer. 2021 Apr;9(4):e002038. doi: 10.1136/jitc-2020-002038.

  PMID: 33827904 BACKGROUND

• Byun HK, Kim N, Park S, Seong J. Acute severe lymphopenia by radiotherapy is associated with reduced overall survival in hepatocellular carcinoma. Strahlenther Onkol. 2019 Nov;195(11):1007-1017. doi: 10.1007/s00066-019-01462-5. Epub 2019 Apr 15.

  PMID: 30989242 BACKGROUND

• Theelen WSME, Peulen HMU, Lalezari F, van der Noort V, de Vries JF, Aerts JGJV, Dumoulin DW, Bahce I, Niemeijer AN, de Langen AJ, Monkhorst K, Baas P. Effect of Pembrolizumab After Stereotactic Body Radiotherapy vs Pembrolizumab Alone on Tumor Response in Patients With Advanced Non-Small Cell Lung Cancer: Results of the PEMBRO-RT Phase 2 Randomized Clinical Trial. JAMA Oncol. 2019 Sep 1;5(9):1276-1282. doi: 10.1001/jamaoncol.2019.1478.

  PMID: 31294749 BACKGROUND

• Luke JJ, Lemons JM, Karrison TG, Pitroda SP, Melotek JM, Zha Y, Al-Hallaq HA, Arina A, Khodarev NN, Janisch L, Chang P, Patel JD, Fleming GF, Moroney J, Sharma MR, White JR, Ratain MJ, Gajewski TF, Weichselbaum RR, Chmura SJ. Safety and Clinical Activity of Pembrolizumab and Multisite Stereotactic Body Radiotherapy in Patients With Advanced Solid Tumors. J Clin Oncol. 2018 Jun 1;36(16):1611-1618. doi: 10.1200/JCO.2017.76.2229. Epub 2018 Feb 13.

  PMID: 29437535 BACKGROUND

• Benedict SH, Yenice KM, Followill D, Galvin JM, Hinson W, Kavanagh B, Keall P, Lovelock M, Meeks S, Papiez L, Purdie T, Sadagopan R, Schell MC, Salter B, Schlesinger DJ, Shiu AS, Solberg T, Song DY, Stieber V, Timmerman R, Tome WA, Verellen D, Wang L, Yin FF. Stereotactic body radiation therapy: the report of AAPM Task Group 101. Med Phys. 2010 Aug;37(8):4078-101. doi: 10.1118/1.3438081.

  PMID: 20879569 BACKGROUND

• Timmerman R. A Story of Hypofractionation and the Table on the Wall. Int J Radiat Oncol Biol Phys. 2022 Jan 1;112(1):4-21. doi: 10.1016/j.ijrobp.2021.09.027. No abstract available.

  PMID: 34919882 BACKGROUND

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Hwakyung BYUN, Phd

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hwakyung BYUN, Phd

CONTACT

007981072098955; hkbyun05@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patients with advanced hepatocellular carcinoma who are indicated for the first-line atezolizumab-bevacizumab combination chemotherapy should begin stereotactic body radiotherapy to one or more but not more than five sites for primary cancer and/or metastatic lesions.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients with advanced hepatocellular carcinoma who are indicated for the first-line atezolizumab-bevacizumab combination chemotherapy should begin stereotactic body radiotherapy to one or more but not more than five sites for primary cancer and/or metastatic lesions.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: September 19, 2024
• Study Start: May 28, 2024
• Primary Completion (Estimated): April 25, 2027
• Study Completion (Estimated): March 27, 2028
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)