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Hepatocellular CarcinomaPhase 2NCT06867432

Efficacy and Safety of Yttrium-90 Microspheres Selective Internal Radiotherapy Combined with Immune Checkpoint Inhibitors and Anti-angiogenesis Drugs Sequential HAIC for Hepatocellular Carcinoma

A Phase 2 study testing Combination Product：t: SIRT-Y90 +HAIC+Atezolizumab + Bevacizumab in people with Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

To observe and evaluate the efficacy and safety of selective internal radiotherapy (SIRT) based on transarterial radioembolization with yttrium (90Y) microspheres combined with immune checkpoint inhibitors and anti-angiogenic-drug sequential hepatic arterial infusion chemotherapy (HAIC) for the treatment of initially… 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?
Combination Product：t: SIRT-Y90 +HAIC+Atezolizumab + Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
1 Mar 2025to 1 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • ≥18 and ≤75 years of age, regardless of gender;
  • Hepatocellular carcinoma (HCC) diagnosed clinically or pathologically with the following characteristics and assessed by the investigator to be initially not amenable to surgical resection but with the potential for surgical resection after conversion therapy;
  • The tumour is confined to a unilateral hepatic lobe, with no extrahepatic metastases and no clinical evidence of high pressure on the imperial vein;
  • CNLC stage Ib-IIIa;
  • ECOG PS score: 0-1;
  • At least one measurable lesion according to mRECIST criteria;
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  • Child-Pugh A;
  • For patients with active hepatitis B virus (HBV): HBV-DNA must be <2,000 IU/mL and must have received at least 14 days of anti-HBV treatment (based on current guidelines, e.g., entecavir) prior to the start of study treatment and be willing to receive antiviral treatment for the full duration of the study; HCV-RNA-positive patients must receive antiviral treatment according to guidelines; and HCV-RNA-positive patients must receive antiviral treatment according to guidelines. HCV-RNA-positive patients must be receiving antiviral therapy according to guidelines and have liver function within CTCAE class 1 ascending;
  • No severe fluid, renal, or coagulation dysfunction:
  • Gynecological examination (excluding the use of any gynecological fluid component and cell growth within 14 days) 1) Neutrophil count (NE) >1.5 x 109/L; 2) Glucose count (NE) >1.5 x 109/L; 3) Glucose count (NE) >1.5 x 109/L; 2) Hemoglobin count (HGB) >90 g/L; 3) Platelet count (PLT) >75×109/L;
  • Liver and kidney function:
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  • Serum creatinine ≤2.0×ULN;
  • Total bilirubin (TBIL) ≤ 2.0 × ULN;
  • Aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × ULN;
  • Completion of 99mTc-MAA and SPECT/CT to meet the treatment requirements for 90Y-SIRT, including but not limited to: (1) pulmonary shunt fraction <20%; (2) single pulmonary absorbed dose <25Gy or cumulative pulmonary absorbed dose <30Gy (Twice Y90 Treatment interval 4-6 weeks);
  • An expected life expectancy of ≥3 months;
  • No previous treatment with transhepatic arterial embolisation (TAE, cTACE or D-TACE), targeted therapy, immunotherapy, radiotherapy or pellet implantation, or SIRT;
  • Women of childbearing potential must have a negative pregnancy test (serum) or urine HCG test within 7 days prior to enrolment and be willing to use appropriate contraception during the trial and for 8 weeks after the last dose of the test drug; for men, they should be surgically sterilised or agree to use appropriate contraception during the trial and for 8 weeks after the last dose of the test drug;
  • The patients were willing to enter the study and signed an informed consent form.

Who cannot join

  • Known fibroplaque HCC, hydatidiform HCC, or mixed hepatocellular carcinoma;
  • Refractory ascites (despite optimal diuretic therapy) or any other clinical signs of liver failure;
  • Untreated or incompletely treated hydronephrosis and/or fundal varices or those at high risk of bleeding as assessed by the investigator, or a history of bleeding due to hydronephrosis or fundal varices within 1 month prior to entry;
  • Major surgical treatment or chemotherapy, radiotherapy or other systemic treatment of the lesion within 1 month prior to entry;
  • Previous allogeneic nickel-hydride cell or solid organ transplantation;
  • Active autoimmune disease requiring systemic therapy (use of palliative medications, steroids, or immunosuppressants); or Thymosin-α1, etc.) within 30 days of the study.
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  • Have received a live attenuated vaccine within 4 weeks prior to the study, or expect to receive such a vaccine during treatment or within 5 months of the last dose.
  • Uncontrolled medical conditions including, but not limited to, persistent infections (other than viral hepatitis), symptomatic cardiac failure, unstable heartburn, colic, cardiac arrest, and heartburn.Uncontrolled medical conditions include, but are not limited to, persistent infections (except viral hepatitis), symptomatic cardiac failure, unstable cardiac colic, irregular heartbeat or severe mental illness;
  • Uncontrolled high blood pressure (systolic > 150 mmHg and/or diastolic > 100 mmHg). 10. other active malignant tumours;
  • Other active malignancies (completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, and superficial bladder cancer).Other active malignancies (except completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, and superficial bladder carcinoma, and any other cancer that has not recurred for at least 5 years);
  • A history of allergy to therapeutic agents and compounds of similar composition;
  • Contraindications to study drug or SIRT therapy, or to angiography as assessed by the Investigator;
  • Pregnant or lactating women and those planning to conceive;
  • Have participated in other research studies in the last 3 months;
  • Inability to understand or unwillingness to sign a written informed consent form.

About this study

Official title: Efficacy and Safety of Yttrium-90 Microspheres Selective Internal Radiotherapy Combined with Immune Checkpoint Inhibitors and Anti-angiogenesis Drugs Sequential Hepatic Arterial Infusion Chemotherapy (HAIC) for Hepatocellular Carcinoma

To observe and evaluate the efficacy and safety of selective internal radiotherapy (SIRT) based on transarterial radioembolization with yttrium (90Y) microspheres combined with immune checkpoint inhibitors and anti-angiogenic-drug sequential hepatic arterial infusion chemotherapy (HAIC) for the treatment of initially unresectable hepatocellular carcinoma with transformation potential.

Being tested
Combination Product：t: SIRT-Y90 +HAIC+Atezolizumab + 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.

  • Combination Product：t: SIRT-Y90 +HAIC+Atezolizumab + BevacizumabDrug

    Single or two-staged delivery of SIRT-Y90 (4 to 6 weeks), followed by 1200mg atezolizumab + 15mg/kg bevacizumab administered by IV at every 3 weeks for 18 months.

    HAIC：administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks.

Study groups in NCT06867432
Study groupRoleWhat they receive
SIRT-Y90+HAIC+PD-1 or PD-L1 inhibitors +targeted therapyExperimentalYttrium (90Y) -SIRT treatment: SIRT enables resin-based yttrium (90Y) microspheres. The radioactivity of yttrium (90Y) and the therapeutic dose were calculated by the body surface product method. The designated dose of yttrium (90Y) microsphere injection was infused after hepatic arterial catheterization, tumor donor artery. The treatment sessions targeted the liver lobe with a larger tumor volume. Patients were monitored for 2 days after treatment. In cases of local tumor progression and contraindications, SIRT may be repeated. Hepatic arterial infusion chemotherapy: specific drug dose, drug method according to current guidelines and drug marketing instructions. Every 3 weeks starting after 3 weeks of yttrium (90Y) -SIRT. PD-L1/PD-1 inhibitors and targeted therapy as specified in the guidelines are allowed to be administered during each treatment
Receives: Drug: Combination Product：t: SIRT-Y90 +HAIC+Atezolizumab + Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR mRESIST

    from the date of enrollment to death from any cause.

    Measured: Prior to surgery

Secondary outcomes (5)

  1. Transformation success rate

    Defined as having at the same time: 1) R0 resection can be achieved and sufficient residual liver volume (FLR) can be preserved; 2) Child-Pugh A or B; 3) ECOG PS score 0 - 1;(4) There is no tumour thrombosis in the main internal secretion vein or inferior vena cava. (5)No tumour thrombus in the main and inferior vena cava; 5) No contraindication to hepatectomy;

    Measured: Up to approximately 48 months

  2. R0 Resection Rate

    R0 resection rate (proportion of resected participants obtaining an R0 resection). R0 resection is defined as a microscopically margin-negative resection, in which no tumor (gross or microscopic) remains in the primary tumor bed.

    Measured: Up to approximately 48 months

  3. Progression-free survival (PFS)

    The time from randomization to the date of tumor progression at any site in the body or death from any cause, whichever is earlier. For those who remain alive and have not progressed, PFS will be censored on the date of the last evaluable tumor assessment on or before the time of analysis or the end of study treatment, whichever is earlier.

    Measured: Up to approximately 48 months

  4. Overall survival (OS)

    OS is defined as the time from randomization to death from any cause.

    Measured: Randomization to death from any cause (up to approximately 3 years)

  5. Pathologic Complete Response (pCR) Rate

    pCR rate is defined as the proportion of participants with an absence of residual tumor at the time of surgery, as assessed by central pathological review.

    Measured: Up to approximately 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2025
  2. Study start1 Mar 2025 (estimated)
  3. Primary completion1 Mar 2026 (estimated)
  4. Study completion1 Mar 2027 (estimated)

Resources

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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06867432
Sponsor's protocol ID
EC-2025-0003
Status last verified
Feb 2025
First submitted
24 Feb 2025
Last updated
10 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Combination Product：t: SIRT-Y90 +HAIC+Atezolizumab + Bevacizumab in people with Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital.

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 20 inclusion and 15 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: opening soon, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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 mRESIST (time frame: Prior to surgery). 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 NCT06867432.

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 10 Mar 2025.

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