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Tests treatment safety and results for Resectable Hepatocellular Carcinoma With High Risk of...
Official title Study to Evaluate the Efficacy and Safety of Neo-Adjuvant TACE and Atezolizumab Plus Bevacizumab Therapy for High-Risk Recurrent Hepatocellular Carcinamo
ClinicalTrials.gov ID: NCT07239245
What this study is testing
What is Atezolizumab?
Atezolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for resectable hepatocellular carcinoma with high risk of recurrence.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, single-arm, multicenter, prospective, phase II clinical study to evaluate the efficacy and safety of TACE combined with Atezolizumab and Bevacizumab as neoadjuvant treatment in Hepatocellular Carcinoma.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Signed Informed Consent Form available
- Patients ≥ 18 years and ≤75years of age at time of signing Informed Consent Form
- Diagnosis of HCC confirmed by histology
- Initially resectable with high-risk recurrence factors. High-risk features for resected patients include tumor size \>5 cm, tumor number \>3...
- Measurable disease (at least one target lesion) according to RECIST v1.1 as determined by the investigator
You likely can't join if
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma, recurrent HCC and diffuse HCC
- Clinically diagnosed hepatic encephalopathy in the last 6 months
- Autoimmune hepatitis (requiring liver puncture)
- History of organ transplantation
- Clinical symptoms of pleural effusion, ascites, pericardial effusion, and any history of kidney disease or nephrotic syndrome
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
See the full eligibility criteria
- Signed Informed Consent Form available
- Patients ≥ 18 years and ≤75years of age at time of signing Informed Consent Form
- Diagnosis of HCC confirmed by histology
- Initially resectable with high-risk recurrence factors. High-risk features for resected patients include tumor size \>5 cm, tumor number \>3, vascular invasion (microvascular invasion or macrovascular invasion - Vp1/Vp2...
- Measurable disease (at least one target lesion) according to RECIST v1.1 as determined by the investigator
- Child-Pugh A
- ECOG PS 0～1
- No prior locoregional or systemic treatment for HCC
- Negative HIV test at screening
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma, recurrent HCC and diffuse HCC
- Clinically diagnosed hepatic encephalopathy in the last 6 months
- Autoimmune hepatitis (requiring liver puncture)
- History of organ transplantation
- Clinical symptoms of pleural effusion, ascites, pericardial effusion, and any history of kidney disease or nephrotic syndrome
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
- A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
- Known severe allergic reaction to contrast (e.g., anaphylaxis).
- Pregnancy or lactating women.
- Inability to provide informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Zhengzhou, Henan, China
- Shenyang, Liaoning, China
- Taiyuan, Shanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Zhengzhou, Henan, China; Shenyang, Liaoning, China; Taiyuan, Shanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.