A Study of Atezolizumab (Tecentriq) in Combination With Bevacizumab to Investigate Safety and Eff… (NCT04487067) | Clinical Trial Compass
CompletedPhase 3
A Study of Atezolizumab (Tecentriq) in Combination With Bevacizumab to Investigate Safety and Efficacy in Patients With Unresectable Hepatocellular Carcinoma Not Previously Treated With Systemic Therapy-Amethista
Italy152 participantsStarted 2020-08-25
Plain-language summary
This is a Phase IIIb, one arm, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab + bevacizumab in patients with unresectable HCC who have received no prior systemic treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Unresectable HCC with diagnosis confirmed by histology, with a biopsy within 6 months from recruitment;
* 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 for HCC;
* At least one measurable untreated lesion;
* Patients who received prior local therapy 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 recruitment;
* Child-Pugh class A within 7 days prior to recruitment;
* Patients must undergo an esophagogastroduodenoscopy (EGD), and all size of varices (small to large) must be assessed. In case of varices at high risk of bleeding (corresponding to medium (F2) or large (F3) varices, or F1 varices with cherry red spots or red wale marking) prophylatic treatment per local standard of care must be adopted prior to enrollment. Patients who have undergone an EGD within 6 months of prior to initiation of study treatment do not need to repeat the procedure provided they had no varices at high risk of bleeding;
* Adequate hematologic and end-organ function
* Resolution of any acute, clinically significant treatment-related toxicity from prior therapy to Grade \<= 1 prior to study entry, with the exception of …
What they're measuring
1
Number of Participants With Grade 3-5 National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE V5) Bleeding/Haemorrhage