Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
Healthy Volunteers
NCT07285850

The Efficacy of Sequential Treatment With Bevacizumab Combined With Atezolizumab in Advanced Liver Cancer With MASLD

Led by Eastern Hepatobiliary Surgery Hospital · Updated on 2025-12-16

20

Participants Needed

1

Research Sites

44 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research plan involves a treatment approach for advanced hepatocellular carcinoma (HCC) in the context of metabolic-associated steatotic liver disease (MASLD). The study aims to compare the efficacy differences between sequential therapy and concurrent therapy using bevacizumab and atezolizumab for advanced HCC in MASLD. The research will focus on evaluating objective response rates, progression-free survival, disease control rates, and overall survival, while utilizing biomarker analysis to elucidate treatment mechanisms. Additionally, the study will examine treatment safety, including the incidence and severity of adverse events.

CONDITIONS

Official Title

The Efficacy of Sequential Treatment With Bevacizumab Combined With Atezolizumab in Advanced Liver Cancer With MASLD

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • ECOG performance status 0-1
  • Diagnosed advanced hepatocellular carcinoma (BCLC stage C or D) not suitable for surgery
  • Moderate to severe fatty liver shown by ultrasound or MRI (Fibroscan CAP > 268 dB/m or MR fat score > 10%)
  • Willingness to use contraception during the study
  • Expected survival of at least 3 months
  • At least one measurable lesion not previously treated with radiation
  • Adequate hematopoietic function (ANC ≥ 1.5×10⁹/L, platelets ≥ 100×10⁹/L, hemoglobin ≥ 90 g/L, no recent transfusion)
  • Adequate liver function (TBIL ≤ 1.5×ULN, AST/ALT/ALP ≤ 2.5×ULN, creatinine ≤ 1.5×ULN, CrCl ≥ 50 mL/min, albumin ≥ 30 g/L, Child-Pugh A)
  • Adequate coagulation function (INR and APTT ≤ 1.5×ULN or within therapeutic range on anticoagulants)
  • Renal function with urinary protein ≤ 1+ (or ≤1 g/24h if >1+)
  • Normal or clinically insignificant cardiac function (ECG normal, LVEF > 50%)
  • Negative pregnancy test for women of childbearing potential within 7 days of dosing
  • Use of effective contraception during and for 12 months after treatment
  • Voluntary informed consent and good compliance
Not Eligible

You will not qualify if you...

  • Excessive alcohol consumption (males > 210 g/week, females > 140 g/week)
  • Tumor lesions previously treated with targeted therapy, immunotherapy, TACE, or radiotherapy
  • Pregnant or breastfeeding women, or positive pregnancy test at baseline
  • Central nervous system metastases
  • Participation in other clinical trials within 4 weeks prior to study
  • Major surgery within 4 weeks or incomplete recovery
  • Radiotherapy within 2 weeks prior to study
  • History or presence of primary immunodeficiency or active autoimmune disease
  • History of organ or stem cell transplantation
  • Use of immunosuppressants or corticosteroids >10 mg/day prednisone within 2 weeks
  • Positive for HIV, syphilis antibodies, or active hepatitis B or C infection
  • Allergy to PD-1 or VEGF monoclonal antibodies or components
  • Symptomatic pleural, pericardial effusion, or ascites requiring intervention
  • Severe cardiovascular disease or recent serious cardiac events
  • History of gastrointestinal surgery or conditions affecting drug absorption
  • Severe uncontrolled infection or moderate/severe renal impairment
  • Active pulmonary diseases such as interstitial pneumonia, COPD, asthma, or tuberculosis
  • Abnormal coagulation or bleeding disorders, or on thrombolytic/anticoagulant therapy (except prophylaxis)
  • Significant bleeding within 3 months
  • Known hereditary or acquired bleeding or thrombotic disorders
  • History of substance abuse or mental disorders affecting compliance
  • Use of warfarin or coumarin derivatives within 14 days before or during treatment
  • Other severe conditions increasing risk or interfering with study
  • Poor compliance or unsuitable for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China, 201805

Actively Recruiting

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Research Team

H

Hao Shen, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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