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

Qilu Pharmaceutical

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Capecitabine; Drug: Bevacizumab; Drug: Sintilimab; Drug: Oxaliplatin injection; Drug: QL1706

Study type: Interventional

Funder types: Industry

Identifiers

NCT05976568

QL1706-308

Details and patient eligibility

About

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.

Enrollment: 668 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 surgery and/or local treatment.
5. No prior systemic therapy for HCC.
6. Child-Pugh ≤7 , no history of hepatic encephalopathy.

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 study treatment.
3. History of liver transplantation, or planned to receive liver transplantation.
4. Moderate or severe ascites with clinical symptoms that require drainage, uncontrolled or moderate or severe pleural and pericardical effusion.
5. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
6. Involvement of both the main portal vein and the left and right branches by portal vein tumor thrombus, or of both the main trunk and the superior mesenteric vein concurrently, or of inferior vena cava.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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668 participants in 4 patient groups

Arm 1

Experimental group

Description:

QL1706 in combination with bevacizumab and chemotherapy

Treatment:

Drug: Bevacizumab

Drug: Capecitabine

Drug: Oxaliplatin injection

Drug: QL1706

Arm 2

Experimental group

Description:

QL1706 in combination with bevacizumab

Treatment:

Drug: Bevacizumab

Drug: QL1706

Arm 3

Experimental group

Description:

QL1706 in combination with chemotherapy

Treatment:

Drug: Capecitabine

Drug: Oxaliplatin injection

Drug: QL1706

Arm 4

Active Comparator group

Description:

Sintilimab in combination with bevacizumab

Treatment:

Drug: Bevacizumab

Drug: Sintilimab