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Immunotherapy for Liver Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization up to approximately 3 years

Awards & highlights

Study Summary

This trial studies new treatments for people with resectable liver cancer. It is open-label, multicenter & flexible to add or remove treatments as needed.

Who is the study for?

This trial is for adults with Hepatocellular Carcinoma (HCC) that can be surgically removed. They must have a confirmed diagnosis, measurable disease, good performance status, and proper liver function. No prior treatments for HCC are allowed, and they should not have any serious co-infections or conditions that could complicate surgery or treatment.Check my eligibility

What is being tested?

The study tests combinations of immunotherapy drugs (Tobemstomig, Tiragolumab, Atezolizumab, Bevacizumab) given before surgery to remove the cancer. It's flexible to adapt by adding new treatments or stopping ones based on results and safety.See study design

What are the potential side effects?

Potential side effects may include immune-related reactions affecting organs, infusion reactions from the drugs being administered into the bloodstream, increased risk of infections due to immune system suppression, bleeding issues related to blood vessel growth inhibition by Bevacizumab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Major Pathologic Response (MPR) Rate

Secondary outcome measures

Event-Free Survival (EFS)

OS Rate at 24 Months

OS Rate at 36 Months

+10 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Tobe + BevExperimental Treatment2 Interventions

Participants in the Tobemstomig + Bev arm will receive up to three cycles of treatment until surgery or unacceptable toxicity, whichever occurs first.

Group II: Atezo + Bev +TiraExperimental Treatment3 Interventions

Participants in the atezolizumab plus bevacizumab plus tiragolumab (Atezo + Bev +Tira) arm will receive up to three cycles of treatment until surgery or unacceptable toxicity, whichever occurs first.

Group III: Atezo + BevExperimental Treatment2 Interventions

Participants in the atezolizumab plus bevacizumab (Atezo + Bev) arm will receive up to three cycles of treatment until surgery or unacceptable toxicity, whichever occurs first.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5860

Bevacizumab

2013

Completed Phase 4

~5280

Tiragolumab

2020

Completed Phase 2

~350

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,432 Previous Clinical Trials

1,090,073 Total Patients Enrolled

7 Trials studying Hepatocellular Carcinoma

5,338 Patients Enrolled for Hepatocellular Carcinoma

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,790 Total Patients Enrolled

4 Trials studying Hepatocellular Carcinoma

5,260 Patients Enrolled for Hepatocellular Carcinoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently benefitting from this experiment?

"Affirmative. According to the information on clinicaltrials.gov, this trial is still actively recruiting participants, having been posted initially on October 13th 2023 and last updated September 19th of the same year. The study requires 150 patients across one site for enrollment."

Answered by AI

Are researchers still admitting participants to this investigation?

"Clinicaltrials.gov affirms that this is an active medical trial, with the initial posting being on October 13th 2023 and its latest update occurring several weeks ago on September 19th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma

2023. "A Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients With Surgically Resectable Hepatocellular Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05908786.

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