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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05976568
• Other study ID #: QL1706-308
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: September 1, 2023
• Est. completion date: September 1, 2027

Study information

• Verified date: July 2023
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: Jian Gao
• Phone: +8613304321400
• Email: jian7.gao[@]qilu-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 668
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• QL1706
7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
• Bevacizumab
15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
• Oxaliplatin injection
85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
• Capecitabine
1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle
• Sintilimab
200 mg administered as IV infusion on Day 1 of each 21-day cycle

Locations

Country	Name	City	State
China	Nanjing Tianyinshan Hospital	Nanjing	Jiangsu
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR) (Phase II)	ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).	Up to approximately 4 years
Primary	Incidence of Adverse Events (AEs) (Phase II)	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.	Up to approximately 4 years
Primary	Overall Survival (OS) (Phase III)	OS was defined as the time from randomization to death due to any cause.	Up to approximately 4 years
Secondary	Objective Response Rate (ORR)	ORR was assessed by investigators per RECIST 1.1	Up to approximately 4 years
Secondary	Disease Control Rate (DCR)	DCR was assessed by investigators per RECIST 1.1	Up to approximately 4 years
Secondary	Duration of Response (DOR)	DOR was assessed by investigators per RECIST 1.1	Up to approximately 4 years
Secondary	Progression-free Survival (PFS)	PFS was assessed by investigators per RECIST 1.1	Up to approximately 4 years
Secondary	Time to progression (TTP)	TTP was assessed by investigators per RECIST 1.1	Up to approximately 4 years
Secondary	Objective Response Rate (ORR)	ORR was assessed by investigators per mRECIST	Up to approximately 4 years
Secondary	Disease Control Rate (DCR)	DCR was assessed by investigators per mRECIST	Up to approximately 4 years
Secondary	Duration of Response (DOR)	DOR was assessed by investigators per mRECIST	Up to approximately 4 years
Secondary	Progression-free Survival (PFS)	PFS was assessed by investigators per mRECIST	Up to approximately 4 years
Secondary	Time to progression (TTP)	TTP was assessed by investigators per mRECIST	Up to approximately 4 years