Hepatocellular Carcinoma Non-resectablePhase 2NCT06397222
Sintilimab Plus Bevacizumab and SIRT for Intermediate-advanced HCC
A Phase 2 study testing Sin-Bev-SIRT in people with Hepatocellular Carcinoma Non-resectable, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This study is conducted to evaluate the efficacy and safety of sintilimab, bevacizumab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma Non-resectable
- What is being tested?
- Sin-Bev-SIRT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 30 Apr 2027
- Phase
- Phase 2
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
- Unresectable HCC (BCLC stage B/C or CNLC II/III) with diagnosis confirmed by histology/cytology or clinically
- At least one measurable untreated lesion
- Intrahepatic tumors can be treated with 1-2 sessions of SIRT
- Child-Pugh score 5-7
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Life expectancy of at least 3 months
- Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA<10^3 IU/mL
- Patients with hepatitis C need to finish the anti-HCV treatment
Who cannot join
- tumor extent ≥70% liver occupation
- Tumor thrombus involving main portal vein or both the first left and right branches of portal vein
- Vena cava invasion
- Central nervous system metastasis
- Metastatic disease that involves major airways or blood vessels
- Patients who previously received hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (TAE), radiotherapy, systemic therapy for HCC
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- History of organ and cell transplantation
- Prior esophageal and/or gastric varices bleeding
- Hepatic dysfunction, such as ascites, esophagogastric varices, hepatic encephalopathy
- Evidence of portal hypertension with high risk of bleeding
- Use of immunosuppressive medications within 4 weeks prior to the first dose of study treatment
- Major surgical procedure or unhealed wound, ulcer, or fracture within 4 weeks prior to the first dose of study treatment
- Any life-threatening bleeding event within the previous 3 months, including the need for blood transfusion, surgical or localized treatment, or ongoing drug therapy
- Peripheral blood white blood cell count <3×10^9/L and platelet count <50×10^9/L
- Prolonged prothrombin time >4 seconds
- Severe organ (heart, lung, kidney) dysfunction
- History of other malignancies
- Co-infection with hepatitis B and C viruses
- Human immunodeficiency virus infection
- Pregnant or lactating patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Mingyue Cai, Dr., +86-20-34156205, cai020@yeah.net
Kangshun Zhu, Dr., +86-20-34156205, zhksh010@163.com
About this study
Official title: Sintilimab, Bevacizumab Plus Y-90 Selective Internal Radiation Therapy for Patients With Unresectable Intermediate-advanced Hepatocellular Carcinoma: a Prospective, Single-center, Single Arm Trial
This study is conducted to evaluate the efficacy and safety of sintilimab, bevacizumab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).
Read the detailed description
This is a single-center, prospective study to evaluate the efficacy and safety of sintilimab, bevacizumab plus SIRT (Sin-Bev-SIRT) in patient with unresectable HCC.
23 patients with unresectable intermediate-advanced HCC (BCLC B/C stage) will be enrolled in this study. The patients will receive sintilimab (200mg I.V. Q3W) and bevacizumab (7.5mg/kg I.V. Q3W) at 3-7 days after SIRT. Sintilimab and bevacizumab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first.
The primary end point of this study is Progression free survival (PFS) per mRECIST. The secondary endpoints are PFS per RECIST 1.1, objective response rate (ORR), disease control rate (DCR), overall survival (OS) and adverse events (AEs).
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Being tested
- Sin-Bev-SIRT
- Keywords
- Hepatocellular Carcinoma, Sintilimab, Bevacizumab, Yttrium-90
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sin-Bev-SIRTDrug
Sintilimab 200mg I.V. q3w and bevacizumab 7.5mg/kg I.V. q3w will be started at 3-7 days after the first SIRT. Treatment of sintilimab and bevacizumab will last up to 24 months. Patients will be allowed to have sintilimab or bevacizumab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Sin-Bev-SIRT | Experimental | Sintilimab, Bevacizumab plus SIRT Receives: Drug: Sin-Bev-SIRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) according to mRECIST
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Measured: 3 years
Secondary outcomes (5)
Progression free survival (PFS) according to RECIST 1.1
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
Measured: 3 years
Objective response rate (ORR)
The percentage of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR) according to mRECIST and RECIST 1.1
Measured: 3 years
Disease control rate (DCR)
The percentage of patients who had a tumor response rating of CR, PR, or stable disease (SD) according to mRECIST and RECIST 1.1
Measured: 3 years
Overall survival (OS)
The time from initiation of treatment until the date of death from any cause.
Measured: 3 years
Adverse Events (AEs)
Number of patients with AEs assessed by NCI CTCAE v5.0.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 May 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-resectableStudies of the same condition, open and under way.
- 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
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397222
- Sponsor's protocol ID
- MIIR-16
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided