Hepatocellular CarcinomaPhase 2NCT05010434
Sintilimab and Bevacizumab Combined With Radiotherapy for Advanced Hepatocellular Carcinoma
A Phase 2 study testing Sintilimab and Bevacizumab Combined with Radiotherapy in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to investigate both the efficacy and safety of sintilimab combined with bevacizumab and radiotherapy in advanced hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Sintilimab and Bevacizumab Combined with Radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2021to Sep 2023
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Treatment-naïve primary HCC (consistent with the American Association for the Study of Liver Diseases 2018 Guideline on Liver Cancer Diagnosis (18)) or initial recurrent HCC after radical resection without any postoperative anti-cancer treatment;
- At least one measurable lesion in the liver on the basis of modified Response Evaluation Criteria in Solid Tumors (mRECIST);
- Presented with Cheng's type I/II/III PVTT;
- Largest tumor size ≤ 10 cm, number of tumors ≤ 3, and remnant liver volume ≥ 50%;
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- Child-Pugh class A;
- Adequate hematological, liver, renal function:
- hemoglobin concentration ≥ 90 g/L;
- neutrophil count ≥ 1.5×109/L;
- platelet count ≥ 60×109/L;
- AST and ALT ≤ 3×upper limit of normal (ULN)
- total bilirubin ≤ 1.5×ULN;
- serum creatinine ≤ 1.5×ULN;
- serum albumin concentration ≥ 30 g/L;
- Life expectancy of at least 3 months.
Who cannot join
- Tumor invasion of the superior mesenteric vein or bile ducts;
- Infiltrative HCC;
- Allergic to research reagents;
- With other malignancies within 5 years;
- With poorly controlled hypertension;
- A past medical history of hepatic decompensation, such as hepatic encephalopathy, refractory ascites, and esophageal or gastric variceal bleeding;
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- A history of autoimmune disease;
- Active infection requiring systemic treatments;
- Severe bleeding;
- With diseases needing daily non-steroidal anti-inflammatory drug (NSAID) therapy;
- With other severe comorbidities.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Sintilimab and Bevacizumab Combined With Radiotherapy in the Treatment of Advanced Hepatocellular Carcinoma
The purpose of this study is to investigate both the efficacy and safety of sintilimab combined with bevacizumab and radiotherapy in advanced hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Sintilimab and Bevacizumab Combined with Radiotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab and Bevacizumab Combined with RadiotherapyDrug
Before radiotherapy: Bevacizumab+Sintilizumab, Q3w, 2 cycles in total. Radiation therapy: 30-50Gy/10 fractions. After radiotherapy: Bevacizumab+Sintilizumab, Q3w until disease progression or toxicity is intolerable.
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab and Bevacizumab Combined with Radiotherapy | Experimental | Not described Receives: Drug: Sintilimab and Bevacizumab Combined with Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR (objective response rate)
the proportion of patients who have a partial or complete response to therapy.
Measured: through study completion, up to 2 year
Secondary outcomes (5)
PFS (progression-free survival)
defined as the time from receiving treatment until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.
Measured: through study completion, up to 2 year
OS (overall survival)
defined as the time from receiving treatment until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.
Measured: through study completion, up to 2 year
DCR (disease control rate)
the proportion of patients whose tumors have shrunk or been stable for a certain period of time, including cases of complete response (CR), partial response (PR), or stable disease (SD).
Measured: through study completion, up to 2 year
LCR (local control rate)
the percentage of lesions with absence of recurrence within the high-dose region （80% isodose volume）
Measured: through study completion, up to 2 year
Adverse effects
Adverse effects of sintilimab and bevacizumab combined with radiotherapy,number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: through study completion, up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start16 Aug 2021
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Responsible party
- Principal investigator, Zhen-Wei Peng, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010434
- Sponsor's protocol ID
- SBRRHCC
- Status last verified
- Sep 2023
- First submitted
- 14 Aug 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu M, Liu Z, Chen S, Luo Z, Tu J, Qiao L, Wu J, Fan W, Peng Z. Sintilimab plus bevacizumab combined with radiotherapy as first-line treatment for hepatocellular carcinoma with portal vein tumor thrombus: A multicenter, single-arm, phase 2 study. Hepatology. 2024 Oct 1;80(4):807-815. doi: 10.1097/HEP.0000000000000776. Epub 2024 Feb 15.
PubMed 38358542
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sintilimab and Bevacizumab Combined With Radiotherapy in the Treatment of Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05010434
- Acronym / sponsor ID
- SBRRHCC
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 18 Aug 2021 (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.
The purpose of this study is to investigate both the efficacy and safety of sintilimab combined with bevacizumab and radiotherapy in advanced 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 |
|---|---|---|
| Sintilimab and Bevacizumab Combined with Radiotherapy | Experimental | Drug: Sintilimab and Bevacizumab Combined with Radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age 18-75 years;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- Treatment-naïve primary HCC (consistent with the American Association for the Study of Liver Diseases 2018 Guideline on Liver Cancer Diagnosis (18)) or initial recurrent HCC after radical resection without any postoperative anti-cancer treatment;
- At least one measurable lesion in the liver on the basis of modified Response Evaluation Criteria in Solid Tumors (mRECIST);
- Presented with Cheng's type I/II/III PVTT;
Key exclusion criteria (11 listed)
- Tumor invasion of the superior mesenteric vein or bile ducts;
- Infiltrative HCC;
- Allergic to research reagents;
- With other malignancies within 5 years;
- With poorly controlled hypertension;
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 |
|---|---|---|
| Sintilimab and Bevacizumab Combined with RadiotherapyBefore radiotherapy: Bevacizumab+Sintilizumab, Q3w, 2 cycles in total. Radiation therapy: 30-50Gy/10 fractions. After radiotherapy: Bevacizumab+Sintilizumab, Q3w until disease progression or toxicity is intolerable. | Drug | Sintilimab and Bevacizumab Combined with Radiotherapy |
Primary outcome
ORR (objective response rate)
Time frame: through study completion, up to 2 year
the proportion of patients who have a partial or complete response to therapy.
5 secondary outcomes
PFS (progression-free survival)
Time frame: through study completion, up to 2 year
OS (overall survival)
Time frame: through study completion, up to 2 year
DCR (disease control rate)
Time frame: through study completion, up to 2 year
LCR (local control rate)
Time frame: through study completion, up to 2 year
Adverse effects
Time frame: through study completion, up to 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 38358542Zhu M, Liu Z, Chen S, Luo Z, Tu J, Qiao L, Wu J, Fan W, Peng Z. Sintilimab plus bevacizumab combined with radiotherapy as first-line treatment for hepatocellular carcinoma with portal vein tumor thrombus: A multicenter, single-arm, phase 2 study. Hepatology. 2024 Oct 1;80(4):807-815. doi: 10.1097/HEP.0000000000000776. Epub 2024 Feb 15.
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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.
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?
A Phase 2 study testing Sintilimab and Bevacizumab Combined with Radiotherapy in people with 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 16 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 Sep 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?
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?
ORR (objective response rate) (time frame: through study completion, up to 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05010434, which also lists 1 linked publication.
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 Sep 2023.