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Unresectable Hepatocellular CarcinomaPhase 2NCT05135364

HAIC Combined With Camrelizumab and TKI for Unresectable Hepatocellular Carcinoma After TACE Failure

A Phase 2 study testing Camrelizumab, HAIC and TKI in people with Unresectable Hepatocellular Carcinoma, run by Yue Han at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The efficacy and safety of HAIC combined with tyrosine kinase inhibitor and immunotherapy have been proved by the clinical research. In this single-arm, open-label, prospective study, for those patients with unresectable primary HCC, in the case of failure of TACE treatment, the combination of HAIC, TKI and… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Unresectable Hepatocellular Carcinoma
What is being tested?
Camrelizumab, HAIC and TKI
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
5 Nov 2021to 5 Dec 2024
Phase
Phase 2
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Paticipants voluntarily joined the study and signed the informed consent form
  • Above 18 years old, both male and female
  • Clinical diagnosis or histopathologically confirmed advanced hepatocellular carcinoma (unresectable)
  • Child-Pugh score ≤ 7
  • BCLC B and C
  • TACE failure: ① Even if chemotherapeutic drugs are changed or the blood supply artery is reassessed, CT/MRI examinations after 2 consecutive TACE treatments 1-3 months show that the target lesions in the liver are compared with the previous TACE count. There are still more than 50% remaining or new lesions; ② extrahepatic metastasis or vascular invasion; ③ postoperative tumor indicators continue to rise (even if there is a short-term decline)
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  • ECOG 0-1
  • The expected survival is more than 3 months
  • The function of vital organs is normal (no blood components, cell growth factor drugs are allowed to be used within 14 days before the first medication)
  • Women of childbearing age need contraception

Who cannot join

  • The patient has any active autoimmune disease or a history of autoimmune disease
  • The patient is using immunosuppressive agents or systemic hormone therapy to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other curative hormones), and continues to use it within 2 weeks before enrollment
  • Patients who have progressed after receiving second-line or above anti-vascular drug therapy in the past, or patients who have received immunotherapeutic drugs such as PD-1 / PD-L1 monoclonal antibody
  • Have received HAIC treatment in the past
  • Severe allergic reaction to other monoclonal antibodies
  • People with known history of central nervous system metastasis or hepatic encephalopathy
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  • Patients whose liver tumor burden is greater than 50% of the total liver volume, or who have received liver transplantation in the past
  • Ascites with clinical symptoms, those who need puncture, drainage, or those who have received ascites drainage within the past 3 months, except for those with only a small amount of ascites on imaging but no clinical symptoms
  • Suffer from high blood pressure and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
  • Have uncontrolled clinical symptoms or diseases of the heart
  • Abnormal coagulation function (INR>2.0, PT>16s), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy, and allow preventive use of low-dose aspirin and low-molecular-weight heparin
  • Have had significant clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months before randomization
  • Arterial/venous thrombosis events that occurred within 6 months before randomization
  • Known hereditary or acquired bleeding and thrombotic tendency
  • Urine routine test showed urine protein ≥ ++ and confirmed 24-hour urine protein content> 1.0 g
  • Patients who have previously received chemotherapy, hormone therapy, and surgery, after the completion of the treatment (last medication) and less than 4 weeks before the study medication; molecular targeted therapy (including other oral targeted drugs used in clinical trials) is less than 5 drugs from the first study medication Patients whose half-life or adverse events (except alopecia) caused by previous treatment have not recovered to ≤ CTCAE Grade 1
  • The patient has active infection, fever of unknown origin within 7 days before medication ≥38.5℃
  • Patients with congenital or acquired immune deficiencies
  • The patient has suffered from other malignant tumors in the past 3 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ)
  • Patients with bone metastases who received palliative radiotherapy in the 4 weeks before participating in the study >5% of the bone marrow area
  • Live vaccines may be vaccinated during the study period less than 4 weeks before the study medication

Trial locations and contacts

1 site in 1 country.

yue Han, phD contact

13511021629

doctorhan@163.com

China1 site, 1 recruiting

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

    yue Han, phD, doctorhan@163.com

    Recruiting

Other trials in China

About this study

Official title: Hepatic Artery Infusion Chemotherapy (HAIC) Combined With Camrelizumab and Tyrosine Kinase Inhibitor for Unresectable Hepatocellular Carcinoma After Transcatheter Arterial Chemoembolization (TACE) Failure: a Single-arm and Open-label Prospective Study

The efficacy and safety of HAIC combined with tyrosine kinase inhibitor and immunotherapy have been proved by the clinical research. In this single-arm, open-label, prospective study, for those patients with unresectable primary HCC, in the case of failure of TACE treatment, the combination of HAIC, TKI and immunotherapy is expected to bring new breakthroughs.

Being tested
Camrelizumab, HAIC, TKI
Keywords
Unresectable, TACE Failure, Hepatocellular Carcinoma
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

    Each infusion is 30 min (not less than 20 min, not more than 60 min), once every 3 weeks

  • HAICDrug

    A chemotherapy regimen perfused through the tumor supplying artery, d1-2 administration, perfused every 4 weeks

  • TKIDrug

    Lenvatinib or Regorafenib

Study groups in NCT05135364
Study groupRoleWhat they receive
Camrelizumab+HAIC+TKI*Experimental*For patients who have not received molecular targeted therapy in the past, lenvatinib is recommended; For patients who have received sorafenib or lenvatinib in the past, regorafenib is recommended.
Receives: Drug: Camrelizumab; Drug: HAIC; Drug: TKI

What is being measured

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

  1. Progression-free survival (according to mRECIST)

    Time from the first tumor progression or death

    Measured: Up to two years

Secondary outcomes (2)

  1. Objective response rate (according to mRECIST and RECIST 1.1)

    Refers to the proportion of patients whose tumors have shrunk to a certain amount and maintained for a certain period of time (mainly for solid tumors), including complete remission (CR, Complete Response) and partial remission (PR, Partial Response)

    Measured: Up to two years

  2. Disease control rate (according to mRECIST and RECIST 1.1)

    Refers to the proportion of patients whose tumors have shrunk or been stable for a certain period of time (mainly for solid tumors), including complete remission (CR, Complete Response), partial remission (PR, Partial Response) and stable (SD, Stable Disease)

    Measured: Up to two years

Timeline

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

  1. First posted26 Nov 2021
  2. Study start5 Nov 2021
  3. Primary completion5 Oct 2022 (estimated)
  4. Study completion5 Dec 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05135364
Sponsor's protocol ID
NCC3153
Status last verified
Nov 2021
First submitted
26 Oct 2021
Last updated
26 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab, HAIC and TKI in people with Unresectable Hepatocellular Carcinoma, run by Yue Han 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 10 inclusion and 21 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 26 Nov 2021. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact yue Han, phD (13511021629, doctorhan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (according to mRECIST) (time frame: Up to two 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 NCT05135364.

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 26 Nov 2021.

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