Clinical trial NCT05976568: A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Official title: A Phase II/III, Randomized, Open-label, Multi-center Study to Evaluate 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Hepatocellular Carcinoma
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-04
Enrollment: 668
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Objective Response Rate (ORR) (Phase II)
timeFrame: Up to approximately 4 years
measure: Incidence of Adverse Events (AEs) (Phase II)
timeFrame: Up to approximately 4 years
measure: Overall Survival (OS) (Phase III)
timeFrame: Up to approximately 4 years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 4 years
measure: Disease Control Rate (DCR)
timeFrame: Up to approximately 4 years
measure: Duration of Response (DOR)
timeFrame: Up to approximately 4 years
measure: Progression-free Survival (PFS)
timeFrame: Up to approximately 4 years
measure: Time to progression (TTP)
timeFrame: Up to approximately 4 years
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 4 years
measure: Disease Control Rate (DCR)
timeFrame: Up to approximately 4 years
measure: Duration of Response (DOR)
timeFrame: Up to approximately 4 years
measure: Progression-free Survival (PFS)
timeFrame: Up to approximately 4 years
measure: Time to progression (TTP)
timeFrame: Up to approximately 4 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Tianyinshan Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jia Fan
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanjing Tianyinshan Hospital
name: Shukui Qin
role: PRINCIPAL_INVESTIGATOR
References: