AzTrials
AzTrials

Advanced Hepatocellular CarcinomaPhase 2NCT06363825

A Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma

A Phase 2 study testing camrelizumab in people with Advanced Hepatocellular Carcinoma, run by Fujian Medical 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 TAE+HAIC combined with camrelizumab and apatinib in the treatment of advanced liver cancer with high tumor load Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Advanced Hepatocellular Carcinoma
What is being tested?
camrelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteChina
Study dates
12 Apr 2024to 11 May 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. The subjects voluntarily joined the study, had good compliance, cooperated with follow-up, and obtained written informed consent;
  • 2. Age: 18 years old ≤80 years old, both male and female;
  • 3. In accordance with the "Norms for the Diagnosis and Treatment of Primary Liver Cancer (2022 edition)" formulated by the National Health Commission and the 2018 EASL liver Cancer guidelines formulated by the European Association for the Study of Hepatology, a definite diagnosis of hepatocellular carcinoma has been made and pathological results have been obtained;
  • 4. There is at least one measurable lesion (spiral CT scan diameter ≥10mm or malignant lymph node short diameter ≥15mm according to RECIST1.1 standard, see Annex 5 for RECIST version 1.1);
  • 5. Have not received systematic treatment before;
  • 6.CNLC was divided into stages Ⅱa-Ⅲb;
Show all 22Show fewer
  • 7. Meet the status of high tumor load, and meet one of the following conditions: 1) High tumor load is defined according to the 7-11 criteria: combined with the number of tumors and the maximum tumor size, high tumor load is defined as and > 11; 2) Combined with primary branch of portal vein and main cancer thrombus;
  • 8. The Child-Pugh classification of liver function is grade A or B (5-8 points);
  • 9.ECOG PS score 0-1;
  • 10. Expected survival ≥12 weeks;
  • 11. If the patient has active hepatitis B virus (HBV) infection: if HBV-DNA≤2000, treatment can be started directly; If HBV-DNA > 2000, start antiviral therapy for one week and then start treatment.
  • 12. The major organs function properly and meet the following criteria:
  • The standard of blood routine examination must meet: (no blood transfusion within 14 days)
  • Hemoglobin (HB) ≥100g/L,
  • White blood cell count (WBC)≥3×10^9/L
  • Absolute neutrophil count (ANC)≥1.5×10^9/L,
  • Platelet (PLT)≥50×10^9/L;
  • Biochemical examination shall meet the following standards:
  • Bilirubin (BIL)<1.5 times the upper limit of normal (ULN);
  • Alanine aminotransferase (ALT) and aspartate aminotransferase AST<5ULN;
  • Serum creatinine (Cr) ≤1.5ULN
  • 13. Women of childbearing age must have a negative pregnancy test (serum) or urine HCG test within 7 days prior to admission and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last dose of the test drug; For men, they should be surgically sterilized or consent to an appropriate method of contraception during the trial and for 8 weeks after the last dose of the trial drug.

Who cannot join

  • 1. Pregnant or lactating women;
  • 2. Patients with autoimmune diseases, organ/hematopoietic stem cell transplantation, or other malignancies (except cured skin basal cell carcinoma and cervical carcinoma in situ);
  • 3. Patients with consciousness disorder or inability to cooperate with treatment, combined with mental illness;
  • 4. Patients who have participated in other clinical trials in the past three months;
  • 5. Received local treatment (such as surgical resection, radiation therapy, ablative therapy, interventional therapy, etc.) within the past 1 month;
  • 6. Thrombotic or embolic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism, except portal vein thrombosis, occurred within 6 months prior to the first dose of the study drug;
Show all 19Show fewer
  • 7. Immunosuppressants or systemic hormone therapy (dose >10mg/ day prednisone or other therapeutic hormones) were used within 14 days before enrollment to achieve immunosuppression;
  • 8. Esophageal (fundus) varices rupture and bleeding within 1 month before treatment;
  • 9. Uncorrectable coagulation dysfunction and severe blood abnormalities, with a tendency to severe bleeding; Platelet count < 50×109/L and severe coagulation dysfunction can not withstand surgery (anticoagulant therapy and/or anticoagulant drug use should be stopped more than 1 week before radiotherapy);
  • 10. Refractory ascites, bad fluid;
  • 11. Active infection, especially inflammation of the biliary system;
  • 12. Severe liver, kidney, heart, lung, brain and other major organ failure;
  • 13. Previous use of targeted drugs, any component of PD-1 MAB or other similar tests A quick person;
  • 14. Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);
  • 15. Previous serious cardiovascular disease, including but not limited to the following diseases: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450 ms in men and ≥470 ms in women); According to NYHA criteria, patients with grade Ⅲ to Ⅳ cardiac insufficiency or left ventricular ejection fraction (LVEF) < 50% indicated by cardiac color ultrasound;
  • 16. Patients with positive urinary protein (urinary protein test 2+ or more, or 24-hour urinary protein quantity > 1.0g);
  • 17. Inability to swallow tablets, malabsorption syndrome or any condition affecting gastrointestinal absorption;
  • 18. Patients with other concomitant diseases that, in the judgment of the investigator, endanger the patient's safety or interfere with the patient's completion of the study.
  • 19. Patients who do not wish to undergo histological examination to confirm the diagnosis.

Trial locations and contacts

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

Yiping Chen contact

13805066904

ptchenyp@163.cm

China1 site, 1 recruiting

  • Xinhua Chen

    Fuzhou

    Yiping Chen, 13805066904

    Recruiting

Other trials in China

About this study

Official title: Single-arm, Prospective Clinical Study of TAE+HAIC Combined With Camrelizumab and Apatinib in the Treatment of Advanced Hepatocellular Carcinoma With High Tumor Load

To evaluate the efficacy and safety of TAE+HAIC combined with camrelizumab and apatinib in the treatment of advanced liver cancer with high tumor load

Read the detailed description

At present, there are no prospective clinical studies using the combination regimen (TAE+HAIC+ Apatinib + camrelizumab) in the treatment of advanced liver cancer. Therefore, in this study, investigators designed a single-arm, prospective, multicenter, phase Ⅱ clinical study of arterial infusion of TAE+HAIC+ Apatinib + camrelizumab in the treatment of advanced liver cancer with high tumor load, to explore the safety and efficacy of this regimen. If study gets positive results, it will provide a reference for the subsequent phase Ⅲ clinical trial design, which is expected to provide a new effective approach for the treatment of advanced liver cancer.

Being tested
camrelizumab
Keywords
hepatocellular carcinoma, high tumor load, camrelizumab, apatinib, HAIC, TAE
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • camrelizumabDrug

    Also called apatinib

    TAE: 3-15ml iodized oil;

    HAIC: Indurating arterial catheter, oxaliplatin 85mg/m^2 D1, arterial infusion, lasting 1-2 hours (d1), LV 400mg/m^2, arterial infusion, lasting 2-3 hours (d1), 5-Fu 400mg/m^2, arterial infusion, lasting 3 hours (d1), and fluorouracil 2400 mg/m^2 for 24-48h;

    camrelizumab: 200mg, ivgtt, 30 min (not less than 20 min, not more than 60 min) every 3 weeks (21 days);

    apatinib mesylate: 250mg, once a day, taken orally (the time of daily administration should be as much as possible), with warm water.Stop for 3 days before next cycle intervention.

    Camrelizumab was given intravenously 1 day before TAE+HAIC treatment for each cycle, TAE+HAIC treatment was given on the second day, and oral apatinib was started after discharge.

Study groups in NCT06363825
Study groupRoleWhat they receive
Single armExperimentalTAE+HAIC combined with camrelizumab and apatinib
Receives: Drug: camrelizumab

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 a best overall result (BOR) of complete remission (CR) or partial remission (PR) as rated according to RECIST 1.1 criteria. If efficacy of CR or PR is achieved, subjects must be confirmed not less than 4 weeks ± 7 days after the initial evaluation.

    Measured: 1 years

Secondary outcomes (5)

  1. Disease control rate (DCR)

    Refers to the proportion of all subjects with a best overall result (BOR) of complete remission (CR), partial remission (PR), and stable disease (SD) as rated according to RECIST 1.1 criteria.

    Measured: 1 years

  2. Progression-free survival (PFS)

    PFS was defined as the date from which the subject was first given medication to the date when tumor progression (as assessed by the criteria, with or without continued treatment) was first recorded or the date of death from any cause, whichever came first.

    Measured: 1 years

  3. Tumor progression time (TTP)

    The definition refers to the time from randomization to the objective progression of the tumor, excluding "death."

    Measured: 1 years

  4. Overall survival (OS)

    Defined as the time between the date of first dose and the death of the subject due to all causes. Subjects who were alive at the last follow-up visit had OS counted as data censored at the time of the last follow-up visit. The OS of subjects who were lost to follow-up was counted as data censored at the time of last confirmed survival prior to the lost follow-up. OS for data censoring was defined as the time from first dose to censoring.

    Measured: 3 years

  5. AE

    Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

    Measured: 1 years

Timeline

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

  1. First posted12 Apr 2024
  2. Study start12 Apr 2024
  3. Primary completion11 Apr 2026 (estimated)
  4. Study completion11 May 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
57 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06363825
Sponsor's protocol ID
MRCTA,ECFAH Of FMU[2024]373
Status last verified
Apr 2024
First submitted
9 Apr 2024
Last updated
17 Apr 2024
Results posted
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 camrelizumab in people with Advanced Hepatocellular Carcinoma, run by Fujian Medical 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 22 inclusion and 19 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 17 Apr 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 Yiping Chen (13805066904, ptchenyp@163.cm), 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: 1 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 NCT06363825.

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 17 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in