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

Phase 2

Not yet recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: QL1706; Drug: Bevacizumab; Drug: Sintilimab; Drug: Oxaliplatin injection; Drug: Capecitabine

• Registration Number: NCT05976568
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-07-28
• Last Update Submitted: 2023-07-28
• Study First Posted: 2023-08-04
• Last Update Posted: 2023-08-04
• Study Start: 2023-09-01
• Primary Completion: 2027-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 668

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	QL1706	QL1706 in combination with bevacizumab and chemotherapy
Arm 1	Bevacizumab	QL1706 in combination with bevacizumab and chemotherapy
Arm 1	Oxaliplatin injection	QL1706 in combination with bevacizumab and chemotherapy
Arm 2	QL1706	QL1706 in combination with bevacizumab
Arm 3	Oxaliplatin injection	QL1706 in combination with chemotherapy
Arm 3	Capecitabine	QL1706 in combination with chemotherapy
Arm 4	Bevacizumab	Sintilimab in combination with bevacizumab
Arm 4	Sintilimab	Sintilimab in combination with bevacizumab
Arm 1	Capecitabine	QL1706 in combination with bevacizumab and chemotherapy
Arm 2	Bevacizumab	QL1706 in combination with bevacizumab
Arm 3	QL1706	QL1706 in combination with chemotherapy

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs) (Phase II)	Up to approximately 4 years	An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Objective Response Rate (ORR) (Phase II)	Up to approximately 4 years	ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Overall Survival (OS) (Phase III)	Up to approximately 4 years	OS was defined as the time from randomization to death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Up to approximately 4 years	ORR was assessed by investigators per mRECIST
Disease Control Rate (DCR)	Up to approximately 4 years	DCR was assessed by investigators per mRECIST
Duration of Response (DOR)	Up to approximately 4 years	DOR was assessed by investigators per mRECIST
Progression-free Survival (PFS)	Up to approximately 4 years	PFS was assessed by investigators per mRECIST
Time to progression (TTP)	Up to approximately 4 years	TTP was assessed by investigators per mRECIST

Trial Locations

Locations (2)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China

Nanjing Tianyinshan Hospital; 🇨🇳 Nanjing, Jiangsu, China