Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT05444088

Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma

Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2024-06-21

129

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To evaluate the tolerability and safety of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC; To evaluate the efficacy of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC.

CONDITIONS

Official Title

Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 75 years, male or female
  • Diagnosed with incurable advanced hepatocellular carcinoma (HCC)
  • For Stage 1: failed standard treatment or unwilling to accept it
  • For Stage 2: no prior immunotherapy and no more than one previous systemic treatment
  • At least one measurable tumor lesion per RECIST v1.1
  • Barcelona Clinic Liver Cancer stage B or C
  • ECOG performance status score of 0 or 1
  • Child-Pugh liver function score of 7 or less
  • Expected survival of at least 3 months
  • Adequate organ function
Not Eligible

You will not qualify if you...

  • Fibrolamellar hepatocellular carcinoma, sarcomatoid HCC, or mixed cholangiocarcinoma/HCC
  • Active, known, or suspected autoimmune disorders
  • Systemic corticosteroid or immunosuppressant treatment within 1 month before first dose
  • Known severe allergic reactions to monoclonal antibodies
  • Central nervous system metastasis or hepatic encephalopathy
  • Liver tumor burden over 50% of total liver volume or prior liver transplantation
  • Symptomatic ascites or pleural effusion requiring drainage, or drainage within 2 weeks before first dose
  • Other malignancies currently or within the past 5 years
  • Poorly controlled hypertension
  • Uncontrolled heart diseases or symptoms
  • Any other conditions that may affect study results

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

Anhui Provincial Hospital Ethics Commitee

Hefei, Anhui, China, 230000

Actively Recruiting

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Research Team

X

Xin Shi

CONTACT

Y

Ying Sun

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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