NCT07285850RecruitingPhase 2/3

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

The Efficacy of Sequential Treatment With Bevacizumab Combined With Atezolizumab in Advanced Liver Cancer With MASLD Background: a Dual Arm, Multicenter, Randomized Controlled Study

Source: ClinicalTrials.gov · Last updated 16 Dec 2025

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 2/3
Study type: Interventional
Enrollment: 20 (estimated)
First submitted: 17 Aug 2025
Start date: 20 Oct 2025
Primary completion date: 30 Aug 2026
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Diseases: Fatty liver disease (MASLD/MASH), Liver and biliary tract cancer
NCT number: NCT07285850

What you commit to

Study type: Interventional · Phase 2/3
Planned participants: 20
From 20 Oct 2025 to the primary completion date, 30 Aug 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Tumor lesions previously treated with targeted therapy, immunotherapy, TACE, or radiotherapy
Participation in another clinical drug or therapy trial within 4 weeks before first study dose
Major surgery within 4 weeks prior to first study dose, or incomplete recovery from surgery
Radiotherapy within 2 weeks before first study dose
Current use of immunosuppressants or corticosteroids (\>10 mg/day prednisone or equivalent) within 2 weeks
Events within 6 months before first dose (e.g., DVT, PE, MI, PCI, ACS, CABG, stroke, TIA, embolism)
Use of warfarin or coumarin derivatives within 14 days before or during treatment

Other illness

History or presence of primary immunodeficiency or active autoimmune disease
History of organ transplantation or hematopoietic stem cell transplantation
Positive for HIV antibody or Treponema pallidum antibody, or active hepatitis B/C infection
Allergy to recombinant humanized PD-1 monoclonal antibody, VEGF monoclonal antibody, or components
Severe cardiovascular disease within 12 months (e.g., CAD, CHF ≥ II, arrhythmias, MI)
History of GI surgery, obstruction, bleeding, dysfunction, or malabsorption affecting drug absorption
Severe uncontrolled infection or comorbidity, or moderate/severe renal impairment
Active pulmonary disease (interstitial pneumonia, COPD, asthma, tuberculosis history)
Significant bleeding within 3 months (e.g., hemoptysis ≥ 2.5 mL, GI bleeding, varices, ulcers, vasculitis)
Known hereditary/acquired bleeding or thrombotic disorders (e.g., hemophilia, thrombocytopenia)
History of substance abuse or mental disorders affecting compliance
Other severe acute/chronic conditions increasing risk or confounding results
Poor compliance or other conditions deemed unsuitable for trial participation

Lab values

Abnormal coagulation (INR \> 2.0, PT \> 16 s), bleeding tendency, or thrombolytic/anticoagulant therapy (except prophylaxis)

Other

Excessive alcohol consumption (weekly ethanol intake: males \< 210 g, females \< 140 g)
Pregnant or breastfeeding women, or positive pregnancy test at baseline
Central nervous system metastases diagnosed by CT, MRI, or PET-CT
Symptomatic pleural effusion, pericardial effusion, or ascites requiring clinical intervention

Criteria the registry did not label

Eligibility Criteria Inclusion Criteria
Age ≥ 18 years old (gender not limited)
ECOG performance status of 0-1
Preoperative imaging diagnosis of advanced hepatocellular carcinoma (BCLC stage C or D, unsuitable for surgery)
Ultrasound or MRI indicating moderate to severe fatty liver (Fibroscan CAP \> 268 dB/m or MR fat score \> 10%)
Willing to use contraceptive measures during the trial period
Expected survival time ≥ 3 months
At least one measurable lesion (per RECIST 1.1) that has not been irradiated
Organ function levels (within 7 days before first study medication) must meet the following:
Hematopoietic function: ANC ≥ 1.5×10⁹/L, PLT ≥ 100×10⁹/L, Hb ≥ 90 g/L, no transfusion within 14 days
Liver function: TBIL ≤ 1.5×ULN, AST/ALT/ALP ≤ 2.5×ULN, serum creatinine ≤ 1.5×ULN, CrCl ≥ 50 mL/min, ALB ≥ 30 g/L, Child-Pugh A
Coagulation function: INR and APTT ≤ 1.5×ULN or within therapeutic range if on anticoagulants
Renal function: urinary protein ≤ 1+ (or ≤1 g/24h if \>1+)
Cardiac function: ECG normal or clinically insignificant, LVEF \> 50%
Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dosing
Men and women of reproductive potential must use effective contraception during and for 12 months after treatment
Participants must voluntarily provide informed consent and have good compliance

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Eastern Hepatobiliary Surgery Hospital Coordinator of this site? Confirm its status	Shanghai	China	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.