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

Primary Purpose

Hepatocellular Carcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
QL1706
Bevacizumab
Oxaliplatin injection
Capecitabine
Sintilimab
Sponsored by
Qilu Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects participate voluntarily and sign informed consent. Age ≥ 18 and ≤ 80 years old, male or female. Histological or cytological or clinical diagnosis of HCC Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment. No prior systemic therapy for HCC. Child-Pugh ≤7 , no history of hepatic encephalopathy. Exclusion Criteria: Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc. History of malignancy other than HCC within 5 years prior to the start of study treatment. History of liver transplantation, or planned to receive liver transplantation. Moderate or severe ascites with clinical symptoms that require drainage, uncontrolled or moderate or severe pleural and pericardical effusion. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. 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.

Sites / Locations

  • Nanjing Tianyinshan Hospital
  • Zhongshan Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

QL1706 in combination with bevacizumab and chemotherapy

QL1706 in combination with bevacizumab

QL1706 in combination with chemotherapy

Sintilimab in combination with bevacizumab

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) (Phase II)
ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
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.
Overall Survival (OS) (Phase III)
OS was defined as the time from randomization to death due to any cause.

Secondary Outcome Measures

Objective Response Rate (ORR)
ORR was assessed by investigators per RECIST 1.1
Disease Control Rate (DCR)
DCR was assessed by investigators per RECIST 1.1
Duration of Response (DOR)
DOR was assessed by investigators per RECIST 1.1
Progression-free Survival (PFS)
PFS was assessed by investigators per RECIST 1.1
Time to progression (TTP)
TTP was assessed by investigators per RECIST 1.1
Objective Response Rate (ORR)
ORR was assessed by investigators per mRECIST
Disease Control Rate (DCR)
DCR was assessed by investigators per mRECIST
Duration of Response (DOR)
DOR was assessed by investigators per mRECIST
Progression-free Survival (PFS)
PFS was assessed by investigators per mRECIST
Time to progression (TTP)
TTP was assessed by investigators per mRECIST

Full Information

First Posted
July 28, 2023
Last Updated
July 28, 2023
Sponsor
Qilu Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05976568
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2027 (Anticipated)
Study Completion Date
September 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
668 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
QL1706 in combination with bevacizumab and chemotherapy
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
QL1706 in combination with bevacizumab
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
QL1706 in combination with chemotherapy
Arm Title
Arm 4
Arm Type
Active Comparator
Arm Description
Sintilimab in combination with bevacizumab
Intervention Type
Drug
Intervention Name(s)
QL1706
Intervention Description
7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin injection
Intervention Description
85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Intervention Description
200 mg administered as IV infusion on Day 1 of each 21-day cycle
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) (Phase II)
Description
ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Time Frame
Up to approximately 4 years
Title
Incidence of Adverse Events (AEs) (Phase II)
Description
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.
Time Frame
Up to approximately 4 years
Title
Overall Survival (OS) (Phase III)
Description
OS was defined as the time from randomization to death due to any cause.
Time Frame
Up to approximately 4 years
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR was assessed by investigators per RECIST 1.1
Time Frame
Up to approximately 4 years
Title
Disease Control Rate (DCR)
Description
DCR was assessed by investigators per RECIST 1.1
Time Frame
Up to approximately 4 years
Title
Duration of Response (DOR)
Description
DOR was assessed by investigators per RECIST 1.1
Time Frame
Up to approximately 4 years
Title
Progression-free Survival (PFS)
Description
PFS was assessed by investigators per RECIST 1.1
Time Frame
Up to approximately 4 years
Title
Time to progression (TTP)
Description
TTP was assessed by investigators per RECIST 1.1
Time Frame
Up to approximately 4 years
Title
Objective Response Rate (ORR)
Description
ORR was assessed by investigators per mRECIST
Time Frame
Up to approximately 4 years
Title
Disease Control Rate (DCR)
Description
DCR was assessed by investigators per mRECIST
Time Frame
Up to approximately 4 years
Title
Duration of Response (DOR)
Description
DOR was assessed by investigators per mRECIST
Time Frame
Up to approximately 4 years
Title
Progression-free Survival (PFS)
Description
PFS was assessed by investigators per mRECIST
Time Frame
Up to approximately 4 years
Title
Time to progression (TTP)
Description
TTP was assessed by investigators per mRECIST
Time Frame
Up to approximately 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects participate voluntarily and sign informed consent. Age ≥ 18 and ≤ 80 years old, male or female. Histological or cytological or clinical diagnosis of HCC Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment. No prior systemic therapy for HCC. Child-Pugh ≤7 , no history of hepatic encephalopathy. Exclusion Criteria: Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc. History of malignancy other than HCC within 5 years prior to the start of study treatment. History of liver transplantation, or planned to receive liver transplantation. Moderate or severe ascites with clinical symptoms that require drainage, uncontrolled or moderate or severe pleural and pericardical effusion. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Gao
Phone
+8613304321400
Email
jian7.gao@qilu-pharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Fan
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shukui Qin
Organizational Affiliation
Nanjing Tianyinshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing Tianyinshan Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
211199
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shukui Qin
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Fan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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