Study Investigating the Association of NP137 With Atezolizumab-Bevacizumab Combination in First L… (NCT05546879) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study Investigating the Association of NP137 With Atezolizumab-Bevacizumab Combination in First Line in Unresectable HCC
France43 participantsStarted 2023-03-15
Plain-language summary
The study will assess the safety of the association of NP137 with the standard of care Atezolizumab-Bevacizumab in first line setting in patients with unresectable hepatocellular carcinoma. The study drug which is tested is the NP137 in association with Atezolizumab-Bevacizumab to allow a better tumor response as well as better survival outcomes with an acceptable safety.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males or females ≥ 18 years of age
. Histologically confirmed (liver biopsy within 24 previous weeks) and documented unresectable hepatocellular carcinoma
. Patients with a BCLC C or BCLC B status ineligible for or in failure of locoregional treatment, as per the Barcelona Clinic Liver Cancer (BCLC) staging system
. No prior systemic therapy for advanced HCC
. Liver tumor burden \< 50% of the liver (per Investigator judgment)
. Child-Pugh A (≤ 6) without any history of cirrhotic decompensation within the past 6 months
. Antiviral therapy required in hepatitis B virus patients (Hepatitis B antigen positive)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1 trial focused on measuring how many patients experience adverse events — does that mean the main goal right now is testing safety rather than proving the treatment works, and what does that mean for me if I were to consider it?
2NP137 is being combined with atezolizumab and bevacizumab, which is already a standard first-line treatment for unresectable HCC — could you explain what adding NP137 might change about the known risk profile of the atezolizumab-bevacizumab combination?
3Since this trial is no longer recruiting new patients, is there any way to still be considered, or are there similar trials testing NP137 or comparable approaches that I should know about?
4Given that this is a first-line trial, would starting here potentially affect my ability to receive the standard atezolizumab-bevacizumab regimen outside of a trial, or access other treatments later if this doesn't work?
5Based on what's been reported so far from this study, have there been any early safety signals or patterns in adverse events that you think are relevant to my specific situation or health history?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage Proportion of patients experiencing adverse events
. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
. Chronic treatment with immunosuppressive agents (like steroids) ≤ 6 weeks prior to first planned dose of treatment.
. Major surgical procedures, open biopsy or significant traumatic injury ≤ 4 weeks prior to first dose of treatment or anticipation of major surgical procedure during the course of the trial, minor surgical procedures ≤ 1 week of first planned dose (the surgical wound must be fully healed)
. Local therapy to liver within 28 days prior to initiation of study treatment or non-recovery from side effects of any such procedure