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

NCT07285850 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: EHBHKY2024-K023-P01182403243
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

HCC - Hepatocellular Carcinoma

Keywords

MASH; HCC; immunotherapy

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  Compare the objective response rate (ORR) of sequential treatment with bevacizumab combined with atezolizumab (sequential group) and concurrent treatment (concurrent group) in advanced HCC under MASLD background, according to RECIST 1.1 criteria.

  6 Months

Study Arms (2)

Sequential treatment of bevacizumab combined with atezolizumab (sequential group)

EXPERIMENTAL

Sequential treatment of bevacizumab combined with atezolizumab (sequential group)

Drug: Sequential treatment of bevacizumab combined with atezolizumab (sequential group)

Simultaneous treatment of bevacizumab combined with atezolizumab (same period group)

ACTIVE COMPARATOR

Simultaneous treatment of bevacizumab combined with atezolizumab (same period group)

Drug: Simultaneous treatment of bevacizumab combined with atezolizumab (same period group)

Interventions

Sequential treatment of bevacizumab combined with atezolizumab (sequential group) DRUG

The first cycle (3 weeks) receives bevacizumab monotherapy, and from the second cycle onwards, it is combined with atezolizumab until disease progression or intolerable toxicity.

Sequential treatment of bevacizumab combined with atezolizumab (sequential group)

Simultaneous treatment of bevacizumab combined with atezolizumab (same period group) DRUG

Simultaneous treatment of bevacizumab combined with atezolizumab (same period group)

Simultaneous treatment of bevacizumab combined with atezolizumab (same period group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Excessive alcohol consumption (weekly ethanol intake: males \< 210 g, females \< 140 g)
• 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 diagnosed by CT, MRI, or PET-CT
• 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
• History or presence of primary immunodeficiency or active autoimmune disease
• History of organ transplantation or hematopoietic stem cell transplantation
• Current use of immunosuppressants or corticosteroids (\>10 mg/day prednisone or equivalent) within 2 weeks
• 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
• Symptomatic pleural effusion, pericardial effusion, or ascites requiring clinical intervention
• Severe cardiovascular disease within 12 months (e.g., CAD, CHF ≥ II, arrhythmias, MI)
• Events within 6 months before first dose (e.g., DVT, PE, MI, PCI, ACS, CABG, stroke, TIA, embolism)

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 201805, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Hao Shen, M.D.

CONTACT

18952681068; shenhaochina@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research Institute

Model Details: Although this study investigates the role of sequential therapy, the experimental design involves two parallel groups. One group receives atezolizumab combined with bevacizumab, while the other group is treated first with bevacizumab followed by sequential administration of atezolizumab. Both groups receive the same drugs, differing only in the sequence of administration.

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: December 16, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)