A Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab Versus Sintilimab or Atezolizumab Combined With Bevacizumab for the Treatment of Advanced Hepatocellular Carcinoma

NCT06618664 | Recruiting Phase 3

• 1 other identifier: SHR-8068-301
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 1

Brief Summary

THis study aims to evaluate the efficacy of SHR-8068 combined with Adebrelimab and Bevacizumab compared with Sintilimab or Atezolizumab combined with Bevacizumab for the first-line treatment of advanced HCC.

Conditions

Advanced Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS)

  From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)

• Overall survival (OS)

  OS is defined as the time from randomization to death from any cause.

  From randomization to death from any cause (whichever occurs first) (up to approximately 36 months)

Secondary Outcomes (6)

• Time to Progression (TTP)

  From randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)]

• Disease Control Rate (DCR)

  From Randomization to the first occurrence of disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or initiation of new anti-tumor therapy (up to approximately 36 months)

• Objective Response Rate (ORR)

  From Randomization to the first occurrence of disease progression or initiation of new anti-tumor therapy (up to approximately 36 months)

• Duration of Response (DoR)

  From the first occurrence of a confirmed objective response to disease progression as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 or death from any cause (whichever occurs first) (up to approximately 36 months)

• Time to Response (TTR)

  From the first occurrence of complete response (CR) or partial response (PR) as determined by the Blinded Independent Review Committee (BIRC) according to RECIST v1.1 (up to approximately 36 months)

Study Arms (2)

SHR-8068 combined with Adebrelimab and Bevacizumab

EXPERIMENTAL

Drug: SHR-8068; Drug: Adebrelimab; Drug: Bevacizumab

Sintilimab combined with Bevacizumab or Atezolizumab

ACTIVE COMPARATOR

Drug: Bevacizumab; Drug: Sintilimab; Drug: Atezolizumab injection

Interventions

SHR-8068 DRUG

SHR-8068: injection, 50 mg/10 mL, intravenous infusion

SHR-8068 combined with Adebrelimab and Bevacizumab

Adebrelimab DRUG

Adebrelimab: injection, 600 mg/12 mL, intravenous infusion

SHR-8068 combined with Adebrelimab and Bevacizumab

Bevacizumab DRUG

Bevacizumab: injection, 100 mg/4 mL, intravenous infusion

SHR-8068 combined with Adebrelimab and Bevacizumab; Sintilimab combined with Bevacizumab or Atezolizumab

Sintilimab DRUG

Sintilimab: injection, 100 mg/10 mL, intravenous infusion

Sintilimab combined with Bevacizumab or Atezolizumab

Atezolizumab injection DRUG

Atezolizumab injection.

Sintilimab combined with Bevacizumab or Atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent.
• ≥ 18 years old, both male and female.
• Unresectable locally advanced or metastatic HCC confirmed by histopathologically/cytologically.
• At least one measurable lesion based on RECIST v1.1 criteria.
• Barcelona clinic liver cancer: Stage B or C.
• No previous systemic antitumor therapy for HCC.
• ECOG PS of 0-1.
• Child-Pugh score of A or B7.
• Expected survival period ≥ 12 weeks.
• Adequate organ function.
• Blood pregnancy negative (women of childbearing age) and non-breastfeeding, effective contraception.

You may not qualify if:

• Hepatic cholangiocarcinoma, mixed hepatocellular carcinoma -cholangiocarcinoma, sarcomatoid hepatocellular carcinoma and fibrolamellar hepatocellular carcinoma.
• Patients with other malignancies currently or within the past 5 years.
• With known severe allergic reactions to any other monoclonal antibodies.
• Patients with known CNS metastasis or hepatic encephalopathy.
• Patients with liver tumor burden greater than 50% of total liver in volume or received liver transplants.
• Patients with symptomatic ascites or pleural effusion.
• Patients with hypertension which cannot be well controlled by antihypertensives.
• Uncontrolled cardiac diseases or symptoms.
• Known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs).
• Major vascular disease occurred in the 6 months before randomization.
• Gastrointestinal perforation or gastrointestinal fistula within 6 months before randomization.
• Major surgery within 28 days before randomization or expected to require major surgery during the study period.
• Active infection, or fever of unknown cause ≥ 38.5℃ in the first 7 days of randomization, or WBC \> 15×109/L at baseline.
• Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known HBV infection, known HCV infection.
• Patients who received live vaccines within 28 days before randomization, or are expected to be vaccinated during the treatment period

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Anhui Provincial Hospital

Hefei, Anhui, 230000, China

RECRUITING

MeSH Terms

Interventions

Bevacizumab; sintilimab; atezolizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Xin Shi

CONTACT

+86-0518-82342973; xin.shi.xs3@hengrui.com

Ying Sun

CONTACT

+86-0518-82342973; ying.sun.ys1@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a randomized, controlled, open-label phase III study designed for efficacy evaluation.

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: October 28, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

CN (1)