Observational study on treatment effectiveness for liver cancer after initial therapy
An Observational Study in Patients With Unresectable Hepatocellular Carcinoma (uHCC) Following Treatment With Atezolizumab Plus Bevacizumab (AB) or With Another Approved Immuno-oncology Immune Checkpoint Inhibitor Combination in First-line
This study is looking at how well second-line treatments work for adults with liver cancer who can't have surgery after they’ve already tried a specific combination of medications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bayer Industry-sponsored |
| Drugs / interventions | atezolizumab, bevacizumab |
| Locations | 20 sites (Baltimore, Maryland and 19 other locations) |
| Trial ID | NCT06117891 on ClinicalTrials.gov |
What this trial studies
This observational study collects data from adults with unresectable hepatocellular carcinoma (uHCC) who have received prior treatment with atezolizumab and bevacizumab or a similar drug combination. Participants will be prescribed a second-line systemic treatment based on their doctor's routine practice. The study aims to gather real-world data on the effectiveness of these subsequent treatments in improving patient outcomes. By focusing on patients who cannot undergo surgery, the study seeks to enhance understanding of treatment pathways for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of unresectable hepatocellular carcinoma who have previously been treated with a first-line immunotherapy combination.
Not a fit: Patients who have not received prior treatment with atezolizumab and bevacizumab or a similar combination may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into effective treatment options for patients with liver cancer who have limited surgical options.
How similar studies have performed: While this study is observational, previous studies on similar treatment approaches have shown promising results in improving patient survival rates.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients, ≥ 18 years of age on the day of signing informed consent. * Confirmed diagnosis of uHCC, treated in a first-line setting with AB or another approved 1L-IO combo therapy. * Decision to initiate treatment with a second-line systemic treatment was made as per investigator's routine treatment practice prior to study enrollment. * Signed informed consent or (for patients under legal age) signed informed assent by the patient (where applicable) and signed informed consent by parents / legal guardian. * No participation in an investigational program with interventions outside of routine clinical practice. Exclusion Criteria: - Not applicable
Where this trial is running
Baltimore, Maryland and 19 other locations
- Mercy Medical Center - Medline Healthcare Services LLC — Baltimore, Maryland, United States (Not_yet_recruiting)
- University of Michigan Health System — Ann Arbor, Michigan, United States (Not_yet_recruiting)
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (Not_yet_recruiting)
- University Of Cincinnati Division Of Hematology Oncology - UC Health System — Cincinnati, Ohio, United States (Not_yet_recruiting)
- Corporal Michael J Crescenz Department Of Veterans Affairs Medical Center — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- Einstein Medical Center — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- Many Locations — Multiple Locations, Argentina (Recruiting)
- Many Locations — Multiple Locations, Brazil (Recruiting)
- Many Locations — Multiple Locations, China (Recruiting)
- Many Locations — Multiple Locations, Colombia (Recruiting)
- Many Locations — Multiple Locations, France (Recruiting)
- Many Locations — Multiple Locations, Greece (Recruiting)
- Many Locations — Multiple Locations, Italy (Recruiting)
- Many Locations — Multiple Locations, Korea, Republic of (Recruiting)
- Many Locations — Multiple Locations, Mexico (Withdrawn)
- Many Locations — Multiple Locations, Saudi Arabia (Not_yet_recruiting)
- Many Locations — Multiple Locations, Spain (Recruiting)
- Many Locations — Multiple Locations, Taiwan (Recruiting)
- Many Locations — Multiple Locations, Thailand (Recruiting)
- Many Locations — Multiple Locations, Turkey (Withdrawn)
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.