Atezolizumab and BEvacizumab With STereotactic Body Radiotherapy for Advanced Hepatocellular Carcinoma
NCT ID: NCT06595108
Last Updated: 2024-11-01
Study Results
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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RECRUITING
NA
33 participants
INTERVENTIONAL
2024-05-28
2028-03-27
Brief Summary
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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.
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Detailed Description
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The followings are evaluation items for each visit.
Visit 1 (-6\~0 weeks) ± 7days \*Screening
* Informed consent form
* Inclusion Criteria/ Exclusion Criteria
* Medical history and physical examination
* Staging via CT, MRI, PET-CT, etc. (PET-CT examination is not compulsory)
* CBC, SMA, PT/aPTT, Tumor markers, Biomarkers
* Stool microbiota NGS
* QoL Questionnaire(EORTC-QLQ-C30 V3)
Visit 2 (0\~7 weeks) ± 7 days \*During SBRT
* Confirmation of adverse events
* QoL Questionnaire(EORTC-QLQ-C30 V3)
Visit 3 (1\~8 weeks) \*1 week after SBRT
* Confirmation of adverse events
* CBC, SMA, PT/aPTT, Tumor markers, Biomarkers
* QoL Questionnaire(EORTC-QLQ-C30 V3)
Visit 4 (6\~9 weeks) ± 7 days \*After 2 cycles of chemotherapy
* Confirmation of adverse events
* CBC, SMA, PT/aPTT, Tumor markers, Biomarkers
* Stool microbiota NGS
* QoL Questionnaire(EORTC-QLQ-C30 V3)
Visit: 5\~12 (3\~36 months) ± 2 weeks \*Follow-up
* Confirmation of adverse events
* Evaluation of effectiveness\* (Imaging tests, Tumor markers, CBC, SMA, PT/aPTT are performed according to the need)
* QoL Questionnaire(EORTC-QLQ-C30 V3)
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with advanced hepatocellular carcinoma
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.
Stereotactic body radiotherapy
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.
Interventions
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Stereotactic body radiotherapy
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.
Eligibility Criteria
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Inclusion Criteria
2. Liver function Child-Pugh class A
3. ECOG 0-1
4. Patient clinically or pathologically diagnosed with hepatocellular carcinoma
5. Advanced hepatocellular carcinoma that is inoperable
6. Satisfies the dose limits for normal organs and lesions of an appropriate size to be included in the scope of radiotherapy.
Exclusion Criteria
2. 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.)
3. Subjects with a high probability of untreated gastric or esophageal varices or bleeding
4. Serious uncontrolled medical comorbidities
5. History of liver transplant surgery
6. Autoimmune liver disease
19 Years
80 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Hwa Kyung Byun
Professor
Principal Investigators
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Hwakyung BYUN, Phd
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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Yongin Severance Hospital
Yongin-si, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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09-2024-0026
Identifier Type: -
Identifier Source: org_study_id
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