A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Last updated: July 28, 2023
Sponsor: Qilu Pharmaceutical Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Carcinoma

Liver Disease

Abdominal Cancer

Treatment

Bevacizumab

Sintilimab

QL1706

Clinical Study ID

NCT05976568
QL1706-308
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to assess the efficacy and safety of QL1706 in combination with bevacizumab and/or chemotherapy versus sintilimab in combination with bevacizumab as first-line treatment in patients with advanced hepatocellular carcinoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects participate voluntarily and sign informed consent.
  2. Age ≥ 18 and ≤ 80 years old, male or female.
  3. Histological or cytological or clinical diagnosis of HCC
  4. Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgeryand/or local treatment.
  5. No prior systemic therapy for HCC.
  6. Child-Pugh ≤7 , no history of hepatic encephalopathy.

Exclusion

Exclusion Criteria:

  1. Histologically or cytologically documented fibrolamellar hepatocellular carcinoma,sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc.
  2. History of malignancy other than HCC within 5 years prior to the start of studytreatment.
  3. History of liver transplantation, or planned to receive liver transplantation.
  4. Moderate or severe ascites with clinical symptoms that require drainage, uncontrolledor moderate or severe pleural and pericardical effusion.
  5. Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis.
  6. Involvement of both the main portal vein and the left and right branches by portalvein tumor thrombus, or of both the main trunk and the superior mesenteric veinconcurrently, or of inferior vena cava.

Study Design

Total Participants: 668
Treatment Group(s): 5
Primary Treatment: Bevacizumab
Phase: 2/3
Study Start date:
September 01, 2023
Estimated Completion Date:
September 01, 2027

Connect with a study center

  • Nanjing Tianyinshan Hospital

    Nanjing, Jiangsu 211199
    China

    Site Not Available

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai 200032
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.