Atezolizumab Plus Bevacizumab With HCC and HBV Infection (NCT04180072) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
Atezolizumab Plus Bevacizumab With HCC and HBV Infection
Taiwan51 participantsStarted 2020-03-12
Plain-language summary
This is a single-arm clinical trial. The main objective is to determine the efficacy of atezolizumab+bevacizumab therapy in patients with advanced hepatocellular carcinoma and with chronic hepatitis B virus infection. All eligible patients will receive atezolizumab + bevacizumab therapy.
Who can participate
Age range20 Years
SexALL
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Inclusion Criteria:
* Age ā„ 20 years, according to local regulation in Taiwan, at time of signing Informed Consent Form.
* Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology.
* Agreement to receive a mandatory tumor biopsy for enrollment into this study.
* Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies.
* No prior systemic therapy (including systemic investigational agents) for HCC.
* Documented chronic HBV infection, defined by positive serum surface antigen (HBsAg), and HBV DNA \> 2000 IU/mL obtained within 28 days prior to initiation of study treatment.
* Agreement to receive anti-HBV treatment (per local standard of care; e.g., entecavir)
1 to 2 weeks prior to study entry and willingness to continue treatment for the length of the study.
* At least one measurable (per RECIST 1.1) lesion. Patients who received prior local therapy (e.g., radiofrequency ablation or transarterial chemoembolization, etc.) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST version 1.1.
* ECOG Performance Status of 0 or 1 within 7 days prior to registration.
* Child-Pugh class A (see Appendix) within 14 days prior to registration
* Adequate hematologic and end-organ function, defined by the follā¦
What they're measuring
1
Best overall response rate
Timeframe: The last patient in has been treated for 6 months. All patients who have a PR or CR before that are responders
Trial details
NCT IDNCT04180072
SponsorNational Health Research Institutes, Taiwan