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AdebrelimabPhase 2NCT05970666

Single Arm, Prospective, Multicenter Clinical Study of TACE With Adebrelimab and Bevacizumab for Unresectable Hepatocellular Carcinoma

A Phase 2 study testing TACE with adebrelimab and bevacizumab in people with Adebrelimab and Hepatocellular Carcinoma, run by The First Affiliated Hospital of Xiamen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To evaluate the efficacy and safety of TACE combined with adebrelimab and bevacizumab transformation in unresectable hepatocellular carcinoma Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
TACE with adebrelimab and bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteChina
Study dates
15 Nov 2023to 15 Nov 2026
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

  • Age: 18 ~ 75, both male and female；
  • Strictly comply with the primary liver cancer diagnosis and treatment standard (2022 edition) clinical diagnosis criteria or primary hepatocellular carcinoma diagnosed by pathological histology or cytology examination, and at least one measurable lesions (according to the RECIST1.1 standard, the spiral CT scan of 10mm or short diameter of 15mm）；
  • Patients without previous systematic treatment and inoperable resection / radical ablation surgery, but who can tolerate TACE;
  • The CNLC stage is Ⅱa-Ⅲb stage;
  • The Child-Pugh grade of liver function is A grade or B grade (5-7 points);
  • The ECOG PS score is 0-1 points;
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  • Expected survival period of 12 weeks;
  • If the patient has active hepatitis B virus (HBV) infection: HBV-deoxyribonucleic acid (DNA) must be <2000 IU / mL (if the study site has only copy / mL testing units, Must be <12500 copy / mL), And received at least 14 days before initiating anti-HBV treatment (according to local standard therapy, e. g. entecavir) and willing to receive antiviral treatment throughout the study; hepatitis C virus (HCV) ribonucleic acid (RNA) positive patients must receive antiviral treatment according to local standard treatment guidelines and liver function within grade CTCAE 1 elevation;
  • Main organs function are normal and meet the following criteria: (1) The blood routine examination standards should be met with: (no blood transfusion within 14 days) A. Hemoglobin (HB), 90g / L, B. White blood cell count (WBC) 3109 / L C. Absolute neutrophil count (ANC) 1.5109 / L, D. Platelet (PLT) 80109 / L;(2) Biochemical examination shall meet the following standards: A. Bilirubin (BIL) <1.5 times the upper limit of normal value (ULN); B. Glutamic gamma aminotransferase (ALT) and glutamate aminotransferase AST <5 ULN; C. Serum creatinine (Cr)≤1.5ULN；
  • Women of childbearing age must have negative pregnancy test (serum) or urine HCG within 7 days before enrollment and are willing to use appropriate contraception during treatment and 24 weeks after the last administration of test drug; for men, surgical sterilization or agree to use appropriate contraception during and 24 weeks after the last administration of trial drug;
  • The subjects volunteered to join the study and had good compliance with the follow-up.

Who cannot join

  • Pregnant or lactating women;
  • The pathology is clearly cholangiocytic carcinoma or mixed cell carcinoma;
  • Diffuse liver cancer;
  • Patients with autoimmune diseases, organ / hematopoietic stem cell transplantation or other malignant tumors (except for cured basal skin cell carcinoma and cervix carcinoma in situ);
  • Patients with consciousness disorders or unable to cooperate with the treatment, combined with patients with mental illness;
  • Patients who have participated in other clinical trials in the recent three months;
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  • Previous history of other malignancies or have received targeted therapy and other PD-1 / PD-L1 inhibitor therapy;
  • Received major surgery or chemotherapy or other systemic therapy for target lesions (including not limited to radiation therapy, ablation therapy, etc.) within 1 month prior to enrollment;
  • Use of immunosuppressants or systemic hormone therapy within 14 days before enrollment to achieve immunosuppressive purposes (dose> 10mg / day prednisone or other efficacy hormones);
  • Liver function was graded as Child-Pugh C, which could not be improved by liver care treatment；
  • esophageal (gastric fundus) varices rupture and bleeding within 1 month before treatment；
  • Uncorrectable coagulopathy and severe blood abnormalities, with severe bleeding tendency. Platelet count <50109 / L and severe coagulation abnormalities against surgery (anticoagulation therapy and / or anticoagulant therapy should be stopped for more than 1 week before radiation therapy);
  • A stubborn amount of ascites, pleural fluid, malignant fluid;
  • Active infection, especially the inflammation of the biliary tract system;
  • Severe functional failure of the liver, kidney, heart, lung, brain and other major organs;
  • Previously allergic to PD-1 / PD-L1 mAb / any component of the targeted drug or other similar trials;
  • Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg);
  • Previous severe cardiovascular disease, including but not limited to the following diseases: myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including 450 ms in QTc men and 470 ms in women); cardiac dysfunction by NYHA, or cardiac ultrasound indicating left ventricular ejection fraction (LVEF) <50%;
  • Patients with positive urinary protein (urinary protein test of 2 + or above, or 24-hour urinary protein quantification of> 1.0g);
  • Failure to swallow tablets, malabsorption syndrome, or any condition affecting gastrointestinal absorption;
  • According to the discretion of the investigator, patients with other concomitant diseases that seriously endanger patient safety or affect the completion of the study;
  • Patients with radiotherapy, targeted therapy, and other contraindications to immunotherapy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jianbo Chen contact

15605921022

274439002@qq.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

    Jianbo Chen, 15605921022, 274439002@qq.com

    Recruiting

Other trials in China

About this study

To evaluate the efficacy and safety of TACE combined with adebrelimab and bevacizumab transformation in unresectable hepatocellular carcinoma

Being tested
TACE with adebrelimab and 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.

  • TACE with adebrelimab and bevacizumabDrug

    TACE treatment once; Adebrelimab: 20mg/kg, every 3 weeks (21 days); Bevacizumab; 15mg/kg, every 3 weeks (21 days);

Study groups in NCT05970666
Study groupRoleWhat they receive
Single armExperimentalNot described
Receives: Drug: TACE with adebrelimab and bevacizumab

What is being measured

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

  1. Objective response rate（ORR）

    Refers to the proportion of all subjects with the best overall response (BOR) as complete remission (CR) or partial remission (PR) according to mRECIST 1.1 criteria.

    Measured: Up to 2 years

  2. Occurence of AE and SAE

    Occurence of Adverse Event (AE) and Serious Adverse Event (SAE) （NCI CTCAE 5.0）

    Measured: Up to 2 years

Secondary outcomes (8)

  1. Radical (R0) resection rate after conversion therapy

    The cut margin had no residual cancer cells

    Measured: Up to 2 years

  2. percent conversion

    The ates of conversion to operable patients in inoperable patients

    Measured: Up to 2 years

  3. Pathological complete response rate (pCR)

    The rate of no remaining tumor cells in the excised tissue samples

    Measured: Up to 2 years

  4. Major pathological response rate (MPR)

    The ratio of the tumor cells active in the removed tissue samples is less than 10%.

    Measured: Up to 2 years

  5. Progression-free survival (PFS)

    PFS was defined as the subject's date from the date of the first dose to the date of the first documented tumor progression (as assessed by mRECIST criteria, with or without continuation of treatment) or the date of death from any cause, whichever occurred first.

    Measured: Up to 2 years

  6. Disease control rate（DCR）

    Refers to the proportion of all subjects with the best overall response (BOR) according to mRECIST criteria as complete remission (CR), partial remission (PR) and stable disease (SD).

    Measured: Up to 2 years

  7. Relapse-free survival time (RFS)

    Time from date of cure surgery to time of recurrence or death

    Measured: Up to 2 years

  8. Overall survival（OS）

    Defined as the time from the date of the first dose to the death of the subject from any cause.

    Measured: Up to 2 years

Timeline

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

  1. First posted1 Aug 2023
  2. Study start15 Nov 2023
  3. Primary completion15 Nov 2026 (estimated)
  4. Study completion15 Nov 2026 (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
71 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05970666
Sponsor's protocol ID
23-OBU-FJ-HCC-II-012
Status last verified
Feb 2024
First submitted
25 Jul 2023
Last updated
28 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TACE with adebrelimab and bevacizumab in people with Adebrelimab and Hepatocellular Carcinoma, run by The First Affiliated Hospital of Xiamen 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 11 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 28 Feb 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.

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?

Contact Jianbo Chen (15605921022, 274439002@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate（ORR） (time frame: Up to 2 years). 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?

On the ClinicalTrials.gov record for NCT05970666.

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 28 Feb 2024.

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