Hepatocellular CarcinomaNCT06199297
Atezolizumab Plus Bevacizumab Versus Sintilimab Plus Bevacizumab With TACE and HAIC in Unresectable Hepatocellular Carcinoma
An observational study of Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
Systemic therapy is the primary option for managing advanced hepatocellular carcinoma (HCC). The combination of atezolizumab and bevacizumab (A+B) has emerged as the first-choice treatment for advanced HCC(IM brave 150). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Atezolizumab combined with Bevacizumab, Sintilimab combined with Bevacizumab and Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 188 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2021to 25 Jul 2023
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective real-world study enrolled patients treated in three medical centers in China, including Sun Yat-sen University Cancer Center, Affiliated Cancer Hospital \& Institute of Guangzhou Medical University, and Sun Yat-Sen Memorial Hospital. These patients, diagnosed with treatment-naive uHCC, underwent simultaneous combination TACE-HAIC and A+B or S+B.
Who may be able to join
- (a) a confirmed diagnosis of uHCC;
- (b) at least one target lesion evaluable by both RECIST 1.1 and mRECIST criteria;
- (c) Child-Pugh Grade A or B.
Who cannot join
- (a) previous exposure to other anti-cancer treatments;
- (b) diagnosis of any other primary malignancy;
- (c) significant esophageal varices or observable red wale marks;
- (d) a history of severe cardiac, pulmonary, or renal comorbidities;
- (e) incomplete follow-up records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atezolizumab Plus Bevacizumab Versus Sintilimab Plus Bevacizumab With Transarterial Chemoembolization and Hepatic Arterial Infusion Chemotherapy in Unresectable Hepatocellular Carcinoma: A Multicenter Real-World Study
Systemic therapy is the primary option for managing advanced hepatocellular carcinoma (HCC). The combination of atezolizumab and bevacizumab (A+B) has emerged as the first-choice treatment for advanced HCC(IM brave 150). The ORIENT-32 study, also reported an ORR of 24% for sintilimab plus a bevacizumab biosimilar (S+B) versus 8% for sorafenib, with significantly longer OS and PFS. Based on those therapeutic advantages over sorafenib, both the A+B and S+B regimens were approved as first-line treatment options for advanced HCC in China. These two trials had very similar designs but included different target populations. Our previous studies have demonstrated that a novel treatment approach combining transarterial chemoembolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) has high efficacy in patients with potentially resectable HCC or portal vein tumor thrombus. However, it remains unknown whether combining immune checkpoint inhibitors and macromolecular VEGF-targeted therapy with transvascular local interventions could improve patient prognosis in uHCC.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Atezolizumab combined with Bevacizumab, Sintilimab combined with Bevacizumab, Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atezolizumab combined with BevacizumabDrug
Atezolizumab 1200 mg IV d1, Q3W, combined with bevacizumab 15 mg/kg IV d1, Q3W treatment, treatment continued until disease progression, development of intolerable toxic reactions
Sintilimab combined with BevacizumabDrug
Sintilimab 200 mg IV d1, Q3W, combined with bevacizumab 15 mg/kg IV d1, Q3W treatment, treatment continued until disease progression, development of intolerable toxic reactions
Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapyProcedure or surgery
The chemoembolization process employed 30 mg/m2 of epirubicin and 2-10 mL of lipiodol. This was followed by FOLFOX-based HAIC, including 85 mg/m2 of oxaliplatin, 400 mg/m2 of leucovorin, and an initial bolus of 400 mg/m2 of 5-FU for 2 h, which was then followed by a sustained infusion of 1200 mg/m2 5-FU for 23 h.
| Study group | Role | What they receive |
|---|---|---|
| ABTH | Atezolizumab plus bevacizumab combined with TACE-HAIC Receives: Drug: Atezolizumab combined with Bevacizumab; Procedure: Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy | |
| SBTH | Sintilimab plus bevacizumab combined with TACE-HAIC Receives: Drug: Sintilimab combined with Bevacizumab; Procedure: Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate，ORR
Evaluated according to the criteria for evaluating efficacy in solid tumors (mRECIST and RECIST 1.1)
Measured: 24 months
progression free survival，PFS
Assessed using the mRECIST criteria, defined as patient survival without tumor progression from the start of randomization to the end of year 2
Measured: 24 months
Secondary outcomes (2)
treatment-related adverse events, TRAEs
incidence rates of treatment-related adverse events during the study
Measured: 24 months
overall survival, OS
Defined as the time from the start of randomization to death from any cause
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start2 Mar 2021
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
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 Sun Yat-sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binkui Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199297
- Sponsor's protocol ID
- B2023-690-01
- Status last verified
- Jan 2024
- First submitted
- 28 Dec 2023
- Last updated
- 26 Jan 2024
- 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 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atezolizumab Plus Bevacizumab Versus Sintilimab Plus Bevacizumab With Transarterial Chemoembolization and Hepatic Arterial Infusion Chemotherapy in Unresectable Hepatocellular Carcinoma: A Multicenter Real-World Study
- ClinicalTrials.gov ID
- NCT06199297
- Acronym / sponsor ID
- B2023-690-01
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 10 Jan 2024 (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.
Systemic therapy is the primary option for managing advanced hepatocellular carcinoma (HCC). The combination of atezolizumab and bevacizumab (A+B) has emerged as the first-choice treatment for advanced HCC(IM brave 150). The ORIENT-32 study, also reported an ORR of 24% for sintilimab plus a bevacizumab biosimilar (S+B) versus 8% for sorafenib, with significantly longer OS and PFS. Based on those therapeutic advantages over sorafenib, both the A+B and S+B regimens were approved as first-line treatment options for advanced HCC in China. These two trials had very similar designs but included different target populations. Our previous studies have demonstrated that a novel treatment approach combining transarterial chemoembolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) has high efficacy in patients with potentially resectable HCC or portal vein tumor thrombus. However, it remains unknown whether combining immune checkpoint inhibitors and macromolecular VEGF-targeted therapy with transvascular local interventions could improve patient prognosis in uHCC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABTH | – | Drug: Atezolizumab combined with Bevacizumab, Procedure: Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapyAtezolizumab plus bevacizumab combined with TACE-HAIC |
| SBTH | – | Drug: Sintilimab combined with Bevacizumab, Procedure: Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapySintilimab plus bevacizumab combined with TACE-HAIC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective real-world study enrolled patients treated in three medical centers in China, including Sun Yat-sen University Cancer Center, Affiliated Cancer Hospital \& Institute of Guangzhou Medical University, and Sun Yat-Sen Memorial Hospital. These patients, diagnosed with treatment-naive uHCC, underwent simultaneous combination TACE-HAIC and A+B or S+B.
Key inclusion criteria (3 listed)
- (a) a confirmed diagnosis of uHCC;
- (b) at least one target lesion evaluable by both RECIST 1.1 and mRECIST criteria;
- (c) Child-Pugh Grade A or B.
Key exclusion criteria (5 listed)
- (a) previous exposure to other anti-cancer treatments;
- (b) diagnosis of any other primary malignancy;
- (c) significant esophageal varices or observable red wale marks;
- (d) a history of severe cardiac, pulmonary, or renal comorbidities;
- (e) incomplete follow-up records.
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 |
|---|---|---|
| Atezolizumab combined with BevacizumabAtezolizumab 1200 mg IV d1, Q3W, combined with bevacizumab 15 mg/kg IV d1, Q3W treatment, treatment continued until disease progression, development of intolerable toxic reactions | Drug | ABTH |
| Sintilimab combined with BevacizumabSintilimab 200 mg IV d1, Q3W, combined with bevacizumab 15 mg/kg IV d1, Q3W treatment, treatment continued until disease progression, development of intolerable toxic reactions | Drug | SBTH |
| Transcatheter arterial chemoembolization and hepatic arterial infusion chemotherapyThe chemoembolization process employed 30 mg/m2 of epirubicin and 2-10 mL of lipiodol. This was followed by FOLFOX-based HAIC, including 85 mg/m2 of oxaliplatin, 400 mg/m2 of leucovorin, and an initial bolus of 400 mg/m2 of 5-FU for 2 h, which was then followed by a sustained infusion of 1200 mg/m2 5-FU for 23 h. | Procedure or surgery | ABTH, SBTH |
Primary outcome
objective response rate，ORR
Time frame: 24 months
Evaluated according to the criteria for evaluating efficacy in solid tumors (mRECIST and RECIST 1.1)
progression free survival，PFS
Time frame: 24 months
Assessed using the mRECIST criteria, defined as patient survival without tumor progression from the start of randomization to the end of year 2
2 secondary outcomes
treatment-related adverse events, TRAEs
Time frame: 24 months
overall survival, OS
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Sun Yat-sen University 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 26 Jan 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate，ORR (time frame: 24 months). 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 26 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.