A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
NCT ID: NCT05976568
Last Updated: 2023-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
668 participants
INTERVENTIONAL
2023-09-01
2027-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
QL1706 in combination with bevacizumab and chemotherapy
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
Arm 2
QL1706 in combination with bevacizumab
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
Arm 3
QL1706 in combination with chemotherapy
QL1706
7.5 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
Arm 4
Sintilimab in combination with bevacizumab
Bevacizumab
15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Sintilimab
200 mg administered as IV infusion on Day 1 of each 21-day cycle
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jia Fan
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Shukui Qin
Role: PRINCIPAL_INVESTIGATOR
Nanjing Tianyinshan Hospital
Locations
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Nanjing Tianyinshan Hospital
Nanjing, Jiangsu, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Shukui Qin
Role: primary
Jia Fan
Role: primary
Other Identifiers
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QL1706-308
Identifier Type: -
Identifier Source: org_study_id
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