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Hepatocellular CarcinomaPhase 1NCT05363722

A Clinical Study to Observe the Effectiveness and Safety of IBI310, Bevacizumab Combined With Sintilimab in the Treatment of Advanced Hepatocellular Carcinoma

A Phase 1 study testing IBI310（0.5mg/kg）, IBI310（0.3mg/kg） and sintilimab in people with Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a randomized, open-label, multicenter Phase Ib study to evaluate the effectiveness and safety of different doses of IBI310, bevacizumab combined with sintilimab in patients with locally advanced or metastatic HCC who have not previously received systemic therapy, are unsuitable for radical surgical resection… 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?
IBI310（0.5mg/kg）, IBI310（0.3mg/kg） and sintilimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
May 2022to Apr 2024
Phase
Phase 1
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

  • Histologically/cytologically confirmed hepatocellular carcinoma, or meeting the clinical diagnostic criteria for hepatocellular carcinoma ;
  • Aged ≥18 years,≤75 years;
  • ECOG performance status score of 0 or 1 point;
  • Barcelona Clinic Liver Cancer (BCLC) stage C, or Stage B not suitable for radical surgery and/or local treatment;
  • No systemic antitumor treatment for hepatocellular carcinoma before the first administration;
  • At least 1 measurable lesion according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST V1.1), or measurable lesion with definite progression after local treatment (based on RECIST V1.1 criteria);
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  • Child-Pugh Class A or B(≤7);
  • Adequate organ and bone marrow function.
  • Expected life time is over 12 weeks.
  • Take effective contraceptive measures
  • Willing to attend the study and having given the ICF

Who cannot join

  • Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC
  • History of hepatic encephalopathy or liver transplantation
  • Pleural, ascites, and pericardial effusion with clinical symptoms requiring drainage
  • HBV-DNA>2000 IU/ML or 10^4 copies/ml；Untreated positive HCV-RNA；HbsAg and anti-HCV antibody were both positive
  • History of GI bleeding within 6 months, or severe (G3) varices at endoscopy within 3 months
  • Arteriovenous embolism within 6 months
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  • The tumor thrombus involved both main and branch portal veins, main portal veins and mesenteric veins or inferior vena cava.
  • Antiplatelet drugs were administered for 10 days for therapeutic purposes 2 weeks before administration
  • Uncontrolled hypertension
  • Unrecovered AE（>CTCAE grade 1） due to previous treatment
  • Heart failure (NYHA Classification III-IV), or poorly controlled arrhythmias
  • History of gastrointestinal perforation, fistula, intestinal obstruction, extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea
  • With lung fibrosis, interstitial lung disease, pneumoconiosis, drug-associated pneumonia and serious impairment in lung function
  • Active tuberculosis
  • Infected with HIV or syphilis
  • Severe infections that are active or clinically poorly controlled
  • Use of immunosuppressive drugs within 4 weeks prior to initial dosing
  • Receipt of live attenuated vaccine within 4 weeks prior to randomization
  • Significant traumatic injury or major surgical procedure within 28 days prior to randomization
  • Other conditions that the investigator judged inappropriate for inclusion
  • Prior immunotherapy or targeted therapy
  • Treatment of Traditional Chinese medicine with anti-tumor indications or drugs with immunomodulatory effects whitin 2 weeks
  • Pregnant or breast-feeding women

About this study

Official title: A Randomized, Open-label, Multicenter Phase Ib Clinical Study to Observe the Effectiveness and Safety of Different Doses of IBI310,Bevacizumab Combined With Sintilimab in the First-line Treatment of Advanced Hepatocellular Carcinoma

This is a randomized, open-label, multicenter Phase Ib study to evaluate the effectiveness and safety of different doses of IBI310, bevacizumab combined with sintilimab in patients with locally advanced or metastatic HCC who have not previously received systemic therapy, are unsuitable for radical surgical resection or local treatment, or have progressive disease after surgical resection or local treatment.

Being tested
IBI310（0.5mg/kg）, IBI310（0.3mg/kg）, 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.

  • IBI310（0.5mg/kg）Drug

    IBI310 0.5mg/kg IV d1 Q6W

  • IBI310（0.3mg/kg）Drug

    IBI310 0.3mg/kg IV d1 Q6W

  • sintilimabDrug

    sintilimab 200 mg IV d1 Q3W

  • bevacizumabDrug

    bevacizumab 15 mg/kg IV d1，Q3W

Study groups in NCT05363722
Study groupRoleWhat they receive
Arm A（IBI310 0.5mg/kg）ExperimentalIBI310 0.5mg/kg IV d1 Q6W, sintilimab 200mg IV d1 Q3W, combined with bevacizumab 15mg/kg IV d1，Q3W
Receives: Drug: IBI310（0.5mg/kg）; Drug: sintilimab; Drug: bevacizumab
Arm B（IBI310 0.3mg/kg）ExperimentalIBI310 0.3mg/kg IV d1 Q6W, sintilimab 200mg IV d1 Q3W, combined with bevacizumab 15mg/kg IV d1，Q3W
Receives: Drug: IBI310（0.3mg/kg）; Drug: sintilimab; Drug: bevacizumab

What is being measured

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

  1. Objective response rate (ORR)

    efficacy

    Measured: The proportion of patients with complete response or partial response, through study completion, an average of 3 years

Secondary outcomes (10)

  1. Duration of Response（DOR）according to RECIST V1.1 criteria

    efficacy

    Measured: From date of randomization until the date of first documented progression, up to 48 months

  2. Duration of Response（DOR）according to mRECIST criteria

    efficacy

    Measured: From date of randomization until the date of first documented progression, up to 48 months

  3. Disease Control Rate（DCR） according to RECIST V1.1 criteria

    efficacy

    Measured: The percentage of patients whose therapeutic intervention has led to a complete response, partial response, or stable disease, through study completion, an average of 3 years

  4. Disease Control Rate（DCR） according to mRECIST criteria

    efficacy

    Measured: The percentage of patients whose therapeutic intervention has led to a complete response, partial response, or stable disease, through study completion, an average of 3 years

  5. Time to Progression（TTP）according to RECIST V1.1 criteria

    efficacy

    Measured: From date of randomization until the date of first documented progression, up to 48 months

  6. Time to Progression（TTP）according to mRECIST criteria

    efficacy

    Measured: From date of randomization until the date of first documented progression, up to 48 months

  7. Progresison Free Surviva（PFS）according to RECIST V1.1 criteria

    efficacy

    Measured: From date of randomization until the date of the first documented progression or date of death from any cause, whichever comes first, up to 48 months

  8. Progresison Free Surviva（PFS）according to mRECIST criteria

    efficacy

    Measured: From date of randomization until the date of the first documented progression or date of death from any cause, whichever comes first, up to 48 months

  9. Overall survival (OS)

    efficacy

    Measured: From date of randomization until death from any cause，through study completion, an average of 3 years

  10. Immune Best Overall Response（iBOR）according to iRECIST criteria

    efficacy

    Measured: The best timepoint response recorded from the start of the study treatment until the end of treatment, taking into account any requirement for confirmation, through study completion, an average of 3 years

Timeline

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

  1. First posted6 May 2022
  2. Study startMay 2022 (estimated)
  3. Primary completionApr 2023 (estimated)
  4. Study completionApr 2024 (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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05363722
Sponsor's protocol ID
CIBI310Y001
Status last verified
May 2022
First submitted
14 Apr 2022
Last updated
6 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IBI310（0.5mg/kg）, IBI310（0.3mg/kg） and sintilimab in people with Hepatocellular Carcinoma, run by Shanghai Zhongshan 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 11 inclusion and 23 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 6 May 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Objective response rate (ORR) (time frame: The proportion of patients with complete response or partial response, through study completion, an average of 3 years). 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 NCT05363722.

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 6 May 2022.

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