Clinical trial · Observational
The Epidemiology of Patients Treated With ATZ+BEV in Real Life Setting
A Multi-Centric, Retrospective, Real-World Study on First-Line Therapy With Atezolizumab Plus Bevacizumab for Advanced or Unresectable Hepatocellular Carcinoma in Romanian Population
NCT06903663CI-TRIAL-00088656MANIFEST-HCCnot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Hepatocellular carcinoma (HCC) is the sixth most prevalent cancer and the third most frequent cause of cancer-related death globally. This retrospective, multicentric study will be coordinated by Dr. Adrian Radu Vidra (Lead Investigator) from Regional Institute of Gastroenterology and Hepatology "Prof. Dr. Octavian Fodor" Cluj-Napoca (Coordinating Site) to further investigate the clinical and demographic profile of patients receiving first-line treatment with atezolizumab and bevacizumab in the real-world setting of clinical practice from Romania. Participants already taking the combination therapy as part of their regular medical care for HCC will be followed during 3 years.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Adult women and men (≥ 18 years of age) with proven initial diagnosis of HCC
- description
- Patients with HCC following treatment with ATZ plus BEV identified from the patient registry in the hospital with treatment charts between April 1, 2022- December 31, 2024 (index date).
Primary outcomes (1)
- measure
- Description of the epidemiology of patients treated with ATZ+BEV
- timeFrame
- 36 months
- description
- The defined primary study outcome is describing the epidemiology of patients treated with ATZ+BEV in real life setting.
Secondary outcomes (6)
- measure
- Progression-Free Survival (PFS) according to viral and non-viral etiology in the selected cohort
- timeFrame
- 36 months
- description
- PFS is defined as the time from the date of the first therapy administration until radiological disease progression or death, whatever occurred first. Patients still alive and without radiologically confirmed progression at the date of the last contact or data cut-off will be censored.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult women and men (≥ 18 years of age) with proven initial diagnosis of HCC with evidence of loco-regional recurrent or advanced disease not amenable to resection. 2. At least one cycle of therapy with ATZ plus BEV. 3. Eligible individuals will be required to have Baseline (pre-index) EGD available 4. No prior systemic therapy for HCC. 5. Evaluable disease as defined per modified Response Evaluation Criteria in Solid Tumours (mRECIST) V1.1 criterion (At least 1 evaluable CT result over the entire available index and post-index period, excluding the baseline). 6. Patients identified from the patient registry in the hospital with treatment charts between April 1, 2022- December 31, 2024 (index date). 7. Eligible individuals will be required to have data available prior to the index date (pre-index period; baseline characteristics). Exclusion Criteria: 1. A diagnosis of any other primary cancer prior to the index date 2. ATZ plus BEV treatment as part of a clinical trial 3. ATZ or BEV given off-label 4. Patients with incomplete medical records 5. Patients receiving other investigational drugs 6. History of hepatic encephalopathy 7. Patients with brain metastasis 8. HBV and HBC co-infection
References
Publications (15)
- BACKGROUNDKulkarni AV, Tevethia H, Kumar K, Premkumar M, Muttaiah MD, Hiraoka A, Hatanaka T, Tada T, Kumada T, Kakizaki S, Vogel A, Finn RS, Rao PN, Pillai A, Reddy DN, Singal AG. Effectiveness and safety of atezolizumab-bevacizumab in patients with unresectable hepatocellular carcinoma: a systematic review and meta-analysis. EClinicalMedicine. 2023 Aug 30;63:102179. doi: 10.1016/j.eclinm.2023.102179. eCollection 2023 Sep. PMID 37680945
- BACKGROUNDStorandt MH, Zemla TJ, Patell K, Naleid N, Gile JJ, Tran NH, Chakrabarti S, Jin Z, Borad M, Mahipal A. Atezolizumab plus bevacizumab as first-line systemic therapy for hepatocellular carcinoma: a multi-institutional cohort study. Oncologist. 2024 Nov 4;29(11):986-996. doi: 10.1093/oncolo/oyae142. PMID 38979643
- BACKGROUNDBialecki ES, Di Bisceglie AM. Diagnosis of hepatocellular carcinoma. HPB (Oxford). 2005;7(1):26-34. doi: 10.1080/13651820410024049. PMID 18333158
- BACKGROUNDPinero F, da Fonseca LG. Trial eligibility in advanced hepatocellular carcinoma: Does it support clinical practice in underrepresented subgroups? World J Gastroenterol. 2021 Jun 28;27(24):3429-3439. doi: 10.3748/wjg.v27.i24.3429. PMID 34239261
- BACKGROUNDSingal AG, Ozgurdal K, Fan X, Vassilev Z, Pan X, Multani JK, Chen CC, Zhou Z, He J, Pisa F. Real-World Systemic Treatment Patterns after Atezolizumab and Bevacizumab in Patients with Hepatocellular Carcinoma in the United States. Cancers (Basel). 2023 Nov 22;15(23):5532. doi: 10.3390/cancers15235532. PMID 38067235
- BACKGROUNDCheng AL, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Lim HY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Ma N, Nicholas A, Wang Y, Li L, Zhu AX, Finn RS. Updated efficacy and safety data from IMbrave150: Atezolizumab plus bevacizumab vs. sorafenib for unresectable hepatocellular carcinoma. J Hepatol. 2022 Apr;76(4):862-873. doi: 10.1016/j.jhep.2021.11.030. Epub 2021 Dec 11. PMID 34902530