Hepatocellular CarcinomaPhase 2NCT05616390
Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy in Unresectable Hepatocellular Carcinoma
A Phase 2 study testing Sintilimab, Bevacizumab and Liver Protective Support Therapy in people with Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of sintilimab combined with bevacizumab and liver protective support therapy in Child-Pugh B and/or ECOG PS 2 unresectable hepatocellular carcinoma Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Sintilimab, Bevacizumab and Liver Protective Support Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2022to Nov 2025
- Phase
- Phase 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced unresectable hepatocellular carcinoma confirmed by histology or cytology
- Age 20-79
- At least one measurable lesion defined in RECIST version 1.1
- Child Pugh grade B
- ECOG PS score 2
- The expected life is at least 90 days
Who cannot join
- Previously received anti-PD-1, PD-L1, PD-L2, CD137, CTLA-4 antibody treatment, or any other treatment that regulates T cells
- Received systemic corticosteroid or immunosuppressive therapy within 28 days before enrollment
- Complicated with autoimmune diseases or having a history of chronic or recurrent autoimmune diseases
- History of pleural or pericardial adhesions within 28 days before enrollment
- HIV antibody, HTV-Ⅰantibody, HCV antibody, hepatitis B surface protein antigen, hepatitis B surface protein antibody, hepatitis B core protein antibody or any detectable hepatitis B virus DNA test results were positive
- Multiple primary cancers (excluding completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, and any other cancer that has not recurred for at least 5 years)
- Brain or meningeal metastasis (unless asymptomatic and does not require treatment)
- Uncontrollable or serious cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Huikai Li, +862223340123 ext. 3091, lihuikai@tjmuch.com
About this study
Official title: A Study to Evaluate the Efficacy and Safety of the Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy in Child-Pugh B and/or ECOG PS 2 Unresectable Hepatocellular Carcinoma
To evaluate the efficacy and safety of sintilimab combined with bevacizumab and liver protective support therapy in Child-Pugh B and/or ECOG PS 2 unresectable hepatocellular carcinoma
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Sintilimab, Bevacizumab, Liver Protective Support Therapy
- Keywords
- Hepatocellular Carcinoma, Sintilimab, Bevacizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Also called IBI308
200mg IV d1,Q3W
BevacizumabDrug
7.5mg/kg IV d1,Q3W
Liver Protective Support TherapyCombination product
Medical treatment such as liver protection therapy, antiviral therapy, platelet and granulocyte upgrading therapy
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy Receives: Drug: Sintilimab; Drug: Bevacizumab; Combination Product: Liver Protective Support Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Measured: Up to 3 years
Overall survival (OS)
Defined as the time from the date of treatment start to the date of death
Measured: Up to 3 years
Secondary outcomes (3)
Overall response rate (ORR)
Defined as proportion of patients who have a best response of CR or PR
Measured: Up to 1 years
Disease control rate (DCR)
Defined as proportion of patients who have a best response of CR, PR or SD
Measured: Up to 1 years
Quality of Life (QoL)
The improvement in quality of life as measured by the EORTC Quality of Life Questionnaire QLQ-C30 (V3.0)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start9 Nov 2022
- Primary completionNov 2023 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616390
- Sponsor's protocol ID
- L20220940
- Status last verified
- Nov 2022
- First submitted
- 8 Nov 2022
- Last updated
- 21 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy and Safety of the Sintilimab Combined With Bevacizumab and Liver Protective Support Therapy in Child-Pugh B and/or ECOG PS 2 Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05616390
- Acronym / sponsor ID
- L20220940
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Sintilimab, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 15 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.
To evaluate the efficacy and safety of sintilimab combined with bevacizumab and liver protective support therapy in Child-Pugh B and/or ECOG PS 2 unresectable hepatocellular carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Sintilimab, Drug: Bevacizumab, Combination Product: Liver Protective Support TherapySintilimab Combined With Bevacizumab and Liver Protective Support Therapy |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Advanced unresectable hepatocellular carcinoma confirmed by histology or cytology
- Age 20-79
- At least one measurable lesion defined in RECIST version 1.1
- Child Pugh grade B
- ECOG PS score 2
Key exclusion criteria (8 listed)
- Previously received anti-PD-1, PD-L1, PD-L2, CD137, CTLA-4 antibody treatment, or any other treatment that regulates T cells
- Received systemic corticosteroid or immunosuppressive therapy within 28 days before enrollment
- Complicated with autoimmune diseases or having a history of chronic or recurrent autoimmune diseases
- History of pleural or pericardial adhesions within 28 days before enrollment
- HIV antibody, HTV-Ⅰantibody, HCV antibody, hepatitis B surface protein antigen, hepatitis B surface protein antibody, hepatitis B core protein antibody or any detectable hepatitis B virus DNA test results were positive
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 |
|---|---|---|
| SintilimabAlso: IBI308200mg IV d1,Q3W | Drug | experimental group |
| Bevacizumab7.5mg/kg IV d1,Q3W | Drug | experimental group |
| Liver Protective Support TherapyMedical treatment such as liver protection therapy, antiviral therapy, platelet and granulocyte upgrading therapy | Combination product | experimental group |
Primary outcome
Adverse Events (AEs)
Time frame: Up to 3 years
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Overall survival (OS)
Time frame: Up to 3 years
Defined as the time from the date of treatment start to the date of death
3 secondary outcomes
Overall response rate (ORR)
Time frame: Up to 1 years
Disease control rate (DCR)
Time frame: Up to 1 years
Quality of Life (QoL)
Time frame: Up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
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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 2 study testing Sintilimab, Bevacizumab and Liver Protective Support Therapy in people with Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital 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 6 inclusion and 8 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 Mar 2023. 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 phase mean?
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 Huikai Li (862223340123 ext. 3091, lihuikai@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) (time frame: Up to 3 years). The study lists 2 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 Mar 2023.