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Trial Title:
A Phase Ib/II Trial to Evaluate the Safety and Efficacy of QL1706 in Patients With Advanced Hepatocellular Carcinoma
NCT ID:
NCT05603039
Condition:
Advanced Liver Cancer
Conditions: Official terms:
Carcinoma, Hepatocellular
Bevacizumab
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
QL1706
Description:
5 mg/kg#D1#Q3W IV or 7.5 mg/kg#D1#Q3W IV
Arm group label:
QL1706(5mg/kg)
Arm group label:
QL1706(7.5mg/kg)
Intervention type:
Drug
Intervention name:
QL1604
Description:
200mg#D1#Q3W IV
Arm group label:
QL1604
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
15 mg/kg#D1#Q3W IV or 7.5 mg/kg#D1#Q3W IV
Arm group label:
QL1604
Arm group label:
QL1706(5mg/kg)
Arm group label:
QL1706(7.5mg/kg)
Summary:
This is a phase Ib/II trial to evaluate the safety, pharmacokinetics and preliminary
efficacy of QL1706 or QL1604 combined with bevacizumab in patients with advanced
hepatocellular carcinoma.
Detailed description:
This is an open, multicenter phase Ib/II trial of QL1706 or QL1604 combined with
bevacizumabin patients with advanced hepatocellular carcinoma to evaluate the safety, PK
characteristics and preliminary efficacy. This trial is divided into three cohorts,
Cohort A, Cohort B and Cohort C.
Cohort A was the dose exploration phase of the study, with 2 dose groups designed, QL1706
5mg/kg q3w + bevacizumab 7.5mg/kg q3w group and QL1706 5mg/kg q3w + bevacizumab 15mg/kg
q3w group, to explore the safe dose of bevacizumab.
After approximately 20 cases are enrolled in the bevacizumab safety dose group identified
in Cohort A, enrollment will be initiated in Cohort B. Cohort B will be QL1604 200 mg
fixed dose q3w + bevacizumab safety dose, and random enrollment will be used for both
Cohort A and Cohort B.
The decision to initiate a cohort C study will be based on the preliminary results of the
efficacy analysis of cohort A and cohort B. If a Cohort C study is initiated, the Cohort
C dosing regimen will be QL1706 7.5 mg/kg q3w + bevacizumab safe dose q3w.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects participated voluntarily and signed an informed consent form.
2. Age ≥ 18 years old at the time of signing the informed consent form, male or female.
3. Advanced hepatocellular carcinoma diagnosed by histopathology or clinical diagnosis,
with disease unsuitable for radical surgery and/or local treatment, or disease
progression after surgery and/or local treatment.
4. No prior systemic treatment for HCC.
5. Child-Pugh liver function classification of grade A versus better grade B.
6. Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1.
7. Expected survival ≥ 3 months.
(9) Functional level of vital organs must be compliant prior to first administration of
trial drug.
(10) Subject agrees to use effective contraception for contraception from the time of
signing the informed consent until 180 days after the last use of the trial drug. Females
of childbearing age cannot be in pregnancy or breastfeeding.
Exclusion Criteria:
1. Subjects with symptomatic CNS metastases were not allowed to be enrolled.
2. Patients with a history of other malignancies within 5 years prior to signing
informed consent.
3. Active autoimmune disease that may have worsened during the course of receiving
study drug therapy.
4. Concomitant disease that interferes with the subject's ability to complete the
study.
5. History of allogeneic hematopoietic stem cell transplantation or organ
transplantation.
6. HIV-positive patients; HCV antibody-positive and HCV RNA-positive patients; patients
with co-infection with HBV and HCV.
7. Patients with a known history of psychotropic substance abuse, alcoholism, or drug
use
8. Those who have participated in other clinical studies and have used other clinical
trial drugs within 4 weeks prior to the use of the trial drug
9. Prior immunotherapy or prior targeted therapy.
10. PCP treatment requires 2 weeks of elution before enrollment and is prohibited during
the trial.
11. Known previous hypersensitivity to macromolecular protein agents, or any component
of the test drug.
12. Live vaccination within 4 weeks prior to the first administration of the test drug.
13. History of hemoptysis, or history of gastrointestinal bleeding, intestinal
obstruction and/or previous clinical signs or symptoms of gastrointestinal
obstruction.
14. Abdominal or bronchoesophageal fistula, gastrointestinal perforation or
intra-abdominal abscess, major vascular disease.
15. Current or recent treatment with aspirin, clopidogrel, or current or recent
treatment with dipyridamole, ticlopidine, and cilostazol; use of anticoagulation
therapy for therapeutic purposes
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Feng Bi, Professor
Phone:
028-85423203
Email:
bifenggcp@163.com
Start date:
July 1, 2021
Completion date:
December 30, 2023
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/NCT05603039
