Advanced Hepatocellular CarcinomaPhase 1/2NCT05444088
Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma
A Phase 1/2 study testing Adebrelimab, Bevacizumab and SHR-8068 in people with Advanced Hepatocellular Carcinoma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
To evaluate the tolerability and safety of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC; To evaluate the efficacy of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- Adebrelimab, Bevacizumab and SHR-8068
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2022to 30 Jun 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18~75 years old, both male and female;
- Stage 1: pathologically diagnosed, incurable advanced HCC subjects who have failed standard treatment or were unwilling to accept standard treatment;
- Stage 2: pathologically diagnosed, incurable advanced HCC subjects, who have no prior immunotherapy, no more than 1 line of previous system treatment;
- At least one measurable lesion based on RECIST v1.1 criteria;
- Barcelona clinic liver cancer: Stage B or C;
- ECOG PS score: 0-1 points;
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- Child-Pugh score: ≤ 7;
- Expected survival period ≥ 3 months;
- Adequate organ function.
Who cannot join
- Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma / hepatocellular carcinoma;
- Patients with any active, known or suspected autoimmune disorder;
- Systemic treatment with corticosteroids or other immunosuppressants within 1 month before the first dose;
- With known severe allergic reactions to any other monoclonal antibodies;
- Patients with known CNS metastasis or hepatic encephalopathy;
- Patients with liver tumor burden greater than 50% of total liver in volume, or patients who have previously undergone liver transplantation;
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- Patients with symptomatic ascites or pleural effusion requiring paracentesis and drainage, or patients who have undergone ascites or pleural effusion drainage within 2 weeks before the first dose;
- Patients with other malignancies currently or within the past 5 years;
- Patients with hypertension which cannot be well controlled by antihypertensives;
- Uncontrolled cardiac diseases or symptoms;
- Patients with other potential factors that may affect the study results.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anhui Provincial Hospital Ethics Commitee
Hefei, Anhui, 230000
Lianxin Liu, Doctor, +86-13845159888, liulx@ustc.edu.cn
About this study
Official title: An Open-label, Multicenter Phase Ib/II Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma
To evaluate the tolerability and safety of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC; To evaluate the efficacy of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC.
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- Adebrelimab, Bevacizumab, SHR-8068
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
intravenous infusion
BevacizumabDrug
intravenous infusion
SHR-8068Drug
intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Adebrelimab in combination with Bevacizumab | Experimental | Not described Receives: Drug: Adebrelimab; Drug: Bevacizumab |
| Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1 | Experimental | Not described Receives: Drug: Adebrelimab; Drug: Bevacizumab; Drug: SHR-8068 |
| Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2 | Experimental | Not described Receives: Drug: Adebrelimab; Drug: Bevacizumab; Drug: SHR-8068 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
Measured: The observation period is 21 days after the first dose
Incidence and severity of grade ≥3 drug-related adverse events and serious adverse events of the two-drug or three-drug combination
Measured: The observation period is from the time when all informed subjects signed the informed consent to the end of the safety follow-up period, up to 2 years
Objective Response Rate
determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points
Measured: At the time point of every 6 or 9 weeks, up to 2 years
Secondary outcomes (2)
Disease Control Rate, determined using RECIST v1.1 criteria
Measured: At the time point of every 6 or 9 weeks, up to 2 years
Progression-Free-Survival assessed by investigator
Measured: up to 2 years]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start2 Aug 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals 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
- Model description
- This study is a multicenter, open-label, dose-finding and efficacy-expansion phase Ib/II study. The phase Ib design is for dose finding and dose confirmation, using modified 3+3 design; the phase II design is for efficacy expansion through randomization.
- Masking
- None (open label)
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444088
- Sponsor's protocol ID
- SHR-8068-II-201-HCC
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2022
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase Ib/II Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05444088
- Acronym / sponsor ID
- SHR-8068-II-201-HCC
- Conditions
- Advanced Hepatocellular Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 5 Jul 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.
To evaluate the tolerability and safety of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC; To evaluate the efficacy of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is a multicenter, open-label, dose-finding and efficacy-expansion phase Ib/II study. The phase Ib design is for dose finding and dose confirmation, using modified 3+3 design; the phase II design is for efficacy expansion through randomization.
| Arm | Type | Receives |
|---|---|---|
| Adebrelimab in combination with Bevacizumab | Experimental | Drug: Adebrelimab, Drug: Bevacizumab |
| Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1 | Experimental | Drug: Adebrelimab, Drug: Bevacizumab, Drug: SHR-8068 |
| Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2 | Experimental | Drug: Adebrelimab, Drug: Bevacizumab, Drug: SHR-8068 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18~75 years old, both male and female;
- Stage 1: pathologically diagnosed, incurable advanced HCC subjects who have failed standard treatment or were unwilling to accept standard treatment;
- Stage 2: pathologically diagnosed, incurable advanced HCC subjects, who have no prior immunotherapy, no more than 1 line of previous system treatment;
- At least one measurable lesion based on RECIST v1.1 criteria;
- Barcelona clinic liver cancer: Stage B or C;
Key exclusion criteria (11 listed)
- Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma / hepatocellular carcinoma;
- Patients with any active, known or suspected autoimmune disorder;
- Systemic treatment with corticosteroids or other immunosuppressants within 1 month before the first dose;
- With known severe allergic reactions to any other monoclonal antibodies;
- Patients with known CNS metastasis or hepatic encephalopathy;
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 |
|---|---|---|
| Adebrelimabintravenous infusion | Drug | Adebrelimab in combination with Bevacizumab, Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1, Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2 |
| Bevacizumabintravenous infusion | Drug | Adebrelimab in combination with Bevacizumab, Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1, Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2 |
| SHR-8068intravenous infusion | Drug | Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1, Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2 |
Primary outcome
Dose Limiting Toxicity
Time frame: The observation period is 21 days after the first dose
Incidence and severity of grade ≥3 drug-related adverse events and serious adverse events of the two-drug or three-drug combination
Time frame: The observation period is from the time when all informed subjects signed the informed consent to the end of the safety follow-up period, up to 2 years
Objective Response Rate
Time frame: At the time point of every 6 or 9 weeks, up to 2 years
determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points
2 secondary outcomes
Disease Control Rate, determined using RECIST v1.1 criteria
Time frame: At the time point of every 6 or 9 weeks, up to 2 years
Progression-Free-Survival assessed by investigator
Time frame: up to 2 years]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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 Adebrelimab, Bevacizumab and SHR-8068 in people with Advanced Hepatocellular Carcinoma, run by Suzhou Suncadia Biopharmaceuticals 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 11 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 21 Jun 2024. 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 Xin Shi (0518-82342973, xin.shi.xs3@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (time frame: The observation period is 21 days after the first dose). The study lists 3 primary outcomes in all. 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 21 Jun 2024.