Advanced Liver CancerPhase 1/2NCT05603039
A Phase Ib/II Trial to Evaluate the Safety and Efficacy of QL1706 in Patients With Advanced Hepatocellular Carcinoma
A Phase 1/2 study testing QL1706, QL1604 and Bevacizumab in people with Advanced Liver Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Liver Cancer
- What is being tested?
- QL1706, QL1604 and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 30 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects participated voluntarily and signed an informed consent form.
- Age ≥ 18 years old at the time of signing the informed consent form, male or female.
- 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.
- No prior systemic treatment for HCC.
- Child-Pugh liver function classification of grade A versus better grade B.
- Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1.
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- Expected survival ≥ 3 months.
- Functional level of vital organs must be compliant prior to first administration of trial drug.
- 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.
Who cannot join
- Subjects with symptomatic CNS metastases were not allowed to be enrolled.
- Patients with a history of other malignancies within 5 years prior to signing informed consent.
- Active autoimmune disease that may have worsened during the course of receiving study drug therapy.
- Concomitant disease that interferes with the subject's ability to complete the study.
- History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
- HIV-positive patients; HCV antibody-positive and HCV RNA-positive patients; patients with co-infection with HBV and HCV.
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- Patients with a known history of psychotropic substance abuse, alcoholism, or drug use
- 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
- Prior immunotherapy or prior targeted therapy.
- PCP treatment requires 2 weeks of elution before enrollment and is prohibited during the trial.
- Known previous hypersensitivity to macromolecular protein agents, or any component of the test drug.
- Live vaccination within 4 weeks prior to the first administration of the test drug.
- History of hemoptysis, or history of gastrointestinal bleeding, intestinal obstruction and/or previous clinical signs or symptoms of gastrointestinal obstruction.
- Abdominal or bronchoesophageal fistula, gastrointestinal perforation or intra-abdominal abscess, major vascular disease.
- Current or recent treatment with aspirin, clopidogrel, or current or recent treatment with dipyridamole, ticlopidine, and cilostazol; use of anticoagulation therapy for therapeutic purposes
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Feng Bi, Professor, 028-85423203, bifenggcp@163.com
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Advanced Liver Cancer
- Being tested
- QL1706, QL1604, Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706Drug
5 mg/kg#D1#Q3W IV or 7.5 mg/kg#D1#Q3W IV
QL1604Drug
200mg#D1#Q3W IV
BevacizumabDrug
15 mg/kg#D1#Q3W IV or 7.5 mg/kg#D1#Q3W IV
| Study group | Role | What they receive |
|---|---|---|
| QL1706(5mg/kg) | Experimental | QL1706(5mg/kg) Combined with Bevacizumab Receives: Drug: QL1706; Drug: Bevacizumab |
| QL1604 | Experimental | QL1604 Combined with Bevacizumab Receives: Drug: QL1604; Drug: Bevacizumab |
| QL1706(7.5mg/kg) | Experimental | QL1706(7.5mg/kg) Combined with Bevacizumab Receives: Drug: QL1706; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective remission rate (ORR)
The ORR assessed according to RECIST v1.1
Measured: up to 1year
Secondary outcomes (1)
Duration of remission (DOR) Duration of remission (DOR) Duration of remission (DOR) Duration of remission (DOR)
The DOR assessed according to RECIST v1.1
Measured: Every 6 weeks up to 48 weeks during study, and every 12 weeks after the end of treatment up to 1year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 Jul 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Liver CancerStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603039
- Sponsor's protocol ID
- QL1706-106
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05603039
- Acronym / sponsor ID
- QL1706-106
- Conditions
- Advanced Liver Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QL1706(5mg/kg) | Experimental | Drug: QL1706, Drug: BevacizumabQL1706(5mg/kg) Combined with Bevacizumab |
| QL1604 | Experimental | Drug: QL1604, Drug: BevacizumabQL1604 Combined with Bevacizumab |
| QL1706(7.5mg/kg) | Experimental | Drug: QL1706, Drug: BevacizumabQL1706(7.5mg/kg) Combined with Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects participated voluntarily and signed an informed consent form.
- Age ≥ 18 years old at the time of signing the informed consent form, male or female.
- 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.
- No prior systemic treatment for HCC.
- Child-Pugh liver function classification of grade A versus better grade B.
Key exclusion criteria (15 listed)
- Subjects with symptomatic CNS metastases were not allowed to be enrolled.
- Patients with a history of other malignancies within 5 years prior to signing informed consent.
- Active autoimmune disease that may have worsened during the course of receiving study drug therapy.
- Concomitant disease that interferes with the subject's ability to complete the study.
- History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL17065 mg/kg#D1#Q3W IV or 7.5 mg/kg#D1#Q3W IV | Drug | QL1706(5mg/kg), QL1706(7.5mg/kg) |
| QL1604200mg#D1#Q3W IV | Drug | QL1604 |
| Bevacizumab15 mg/kg#D1#Q3W IV or 7.5 mg/kg#D1#Q3W IV | Drug | QL1604, QL1706(5mg/kg), QL1706(7.5mg/kg) |
Primary outcome
Objective remission rate (ORR)
Time frame: up to 1year
The ORR assessed according to RECIST v1.1
1 secondary outcome
Duration of remission (DOR) Duration of remission (DOR) Duration of remission (DOR) Duration of remission (DOR)
Time frame: Every 6 weeks up to 48 weeks during study, and every 12 weeks after the end of treatment up to 1year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing QL1706, QL1604 and Bevacizumab in people with Advanced Liver Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Professor Bi (028-85423203, bifenggcp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective remission rate (ORR) (time frame: up to 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.