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Trial Title:
A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma
NCT ID:
NCT05976568
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Bevacizumab
Capecitabine
Oxaliplatin
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
QL1706
Description:
7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Arm group label:
Arm 1
Arm group label:
Arm 2
Arm group label:
Arm 3
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Arm group label:
Arm 1
Arm group label:
Arm 2
Arm group label:
Arm 4
Intervention type:
Drug
Intervention name:
Oxaliplatin injection
Description:
85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
Arm group label:
Arm 1
Arm group label:
Arm 3
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of
each 21-day cycle
Arm group label:
Arm 1
Arm group label:
Arm 3
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
200 mg administered as IV infusion on Day 1 of each 21-day cycle
Arm group label:
Arm 4
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nanjing Tianyinshan Hospital
Address:
City:
Nanjing
Zip:
211199
Country:
China
Contact:
Last name:
Shukui Qin
Facility:
Name:
Zhongshan Hospital, Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Contact:
Last name:
Jia Fan
Start date:
September 1, 2023
Completion date:
September 1, 2027
Lead sponsor:
Agency:
Qilu Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Qilu Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05976568
