AzTrials
AzTrials

Unrescetable Hepatocellular CarcinomaPhase 2NCT05864755

HAIC Combined With Durvalumab, Tremelimumab and Bevacizumab as Conversion Therapy for Potentially Resectable Hepatocellular Carcinoma

A Phase 2 study testing HAIC+Durvalumab+Tremelimumab+Bevacizumab in people with Unrescetable Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

To evaluate the efficacy and safety of HAIC combined with Durvalumab, Tremelimumab and Bevacizumab as first-line therapy in Unresectable hepatocellular carcinoma Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Unrescetable Hepatocellular Carcinoma
What is being tested?
HAIC+Durvalumab+Tremelimumab+Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
20 Jun 2023to Dec 2025
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provide a written informed consent form (ICF) signed and dated by the patient/legal representative before conducting any research specific procedures, sampling, and analysis specified in the protocol.
  • Before collecting genetic analysis samples (optional), provide a signed and dated written informed consent form for genetic research.
  • At the time of screening, the age should be ≥ 18 years old. For patients under the age of 20 who are enrolled in China, written informed consent from the patient and their legal representative should be obtained.
  • Based on the histopathology results of tumor tissue, a patient with stage C hepatocellular carcinoma complicated with portal vein tumor thrombus BCLC was diagnosed, with portal vein tumor thrombus type I to III. (Cheng's classification indicates that the tumor thrombus is mainly located at the level of the liver segment (secondary branch of the portal vein); Type II refers to the spread of cancer thrombi invading the left or right branch of the portal vein (primary branch of the portal vein); Type III refers to cancer thrombus invading the main portal vein; Type IV refers to tumor thrombus invading superior mesenteric vein or inferior vena cava.
  • No evidence of extrahepatic diseases was found in baseline chest/abdominal/pelvic imaging
  • The disease is not suitable for radical surgery, transplantation, or radical ablation
Show all 23Show fewer
  • The disease must be suitable for TACE and HAIC treatment, and it is expected that TACE treatment for local lesions will not exceed 4 times within 16 weeks [DEB-TACE]
  • The Child Pugh grading of liver function is Grade A,the Eastern Oncology Collaborative Group (ECOG) physical fitness score was 0 or 1
  • Patients with HBV infection [showing positive hepatitis B B virus surface antigen (HBsAg), and/or positive hepatitis B core antibody (anti HBcAb)] and detectable HBV DNA (≥ 10IU/mL or higher than the detection limit according to the local experimental standard) must receive antiviral treatment according to the institutional diagnosis and treatment routine to ensure adequate virus suppression (HBV DNA ≤ 2000IU/mL) before enrollment. Patients must maintain antiviral treatment during the study period and within 6 months after the last administration of the study drug. For patients who are positive for hepatitis B core antibody (HBc) but have not detected HBV DNA (<10 IU/ml or below the detection limit of local laboratory standards), antiviral treatment is not required before enrollment. These patients need to monitor HBV DNA levels during each course of treatment, and once HBV DNA is tested (≥ 10 IU/mL or below the detection limit of local laboratory standards), antiviral treatment begins. Patients who can detect HBV DNA must begin and maintain antiviral therapy during the study period and within 6 months after the last administration of the study drug.
  • According to the following mRECIST criteria, at least one measurable intrahepatic lesion is suitable for repeated evaluation: in intravenous contrast-enhanced CT or MRI scans, the liver lesion shows typical features of HCC, namely arterial phase vascular enhancement, venous phase or delayed phase enhancement rapidly disappears in the non necrotic part at baseline (arterial phase IV contrast agent enhancement), and its longest diameter can be accurately measured to be ≥ 10 mm
  • The definition of good organ and bone marrow function is as follows. Within 14 days before the start of the first dose, standards "a", "b", "c", and "f" cannot be met through blood transfusion, infusion, or receiving supportive therapies such as growth factors
  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count ≥ 1000/µ L
  • Platelet count ≥ 75000/ μ L
  • Total bilirubin ≤ 2.0 × Upper limit of normal value (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN
  • Albumin ≥ 2.8 g/dL
  • International normalized ratio (INR) ≤ 1.6
  • 2+or lower urine test strip reading
  • Calculate creatinine clearance rate (CL) ≥ 30mL/min, and measure male creatinine CL=weight (kg) using Cockcroft Fault (using actual body weight) or 24-hour urine creatinine CL × (140 Age) (mL/min) 72 × Serum creatinine (mg/dL) Female: creatinine CL=weight (kg) × (140- Age) × 0.85（mL/min）72 × Serum creatinine (mg/dL)
  • Must have an expected lifespan of at least 12 weeks
  • Weight>30 kg
  • No gender limit

Who cannot join

  • History of kidney disease or nephrotic syndrome
  • Cardiovascular diseases with clinical significance
  • Major traumatic injury occurred within the first 4 weeks of randomization
  • Known genetic factors for bleeding or thrombosis; Any previous or current evidence indicating a tendency to bleed
  • Systematic anticoagulant therapy is allowed, except for vitamin K antagonists
  • History of arterial embolism events, including stroke or myocardial infarction
Show all 40Show fewer
  • Patients with unhealed wounds, active ulcers, or fractures. For granulation wounds in the second stage of healing, as long as there is no evidence of surface cracking or infection in patients, they meet the inclusion criteria but require wound examination every 3 weeks
  • Abdominal wall fistula or gastrointestinal perforation, refractory unhealed gastric ulcer, or active gastrointestinal bleeding within 6 months before enrollment
  • Patients who have undergone any surgery within the past 28 days (diagnostic biopsy is acceptable)
  • Uncontrolled hypertension is defined as systolic blood pressure>150 mmHg or diastolic blood pressure>90 mmHg, with or without taking antihypertensive drugs. Patients who experience an increase in blood pressure (BP) for the first time can be enrolled if using or adjusting antihypertensive drugs can lower their blood pressure to the inclusion criteria.
  • Diagnosed fibrolaminar HCC, sarcomatous HCC, or mixed cholangiocarcinoma and HCC
  • Have a history of hepatic encephalopathy within the past 12 months, or require medication to prevent or control encephalopathy (such as using lactulose, rifaximin, etc. for hepatic encephalopathy).
  • Large portal vein thrombosis was seen in the baseline/qualification test imaging, and patients with type IV procedures were excluded
  • Patients with infiltrative HCC
  • Have a history of homologous organ transplantation
  • Active or previously recorded autoimmune diseases or inflammatory diseases (including inflammatory bowel disease [such as colitis or Krohn's disease], diverticulitis [except diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome or Wegener's syndrome [such as granulomatous vasculitis, Gray's disease, rheumatoid arthritis, hypophysitis and uveitis]). There are the following exceptions to this standard:
  • Patients with vitiligo or hair loss
  • Patients with stable hypothyroidism after receiving hormone replacement therapy (such as after Hashimoto's thyroiditis) Any chronic skin disease patient who does not require systemic treatment
  • Patients with no active diseases within the past 5 years can be included, but only after consulting the research doctor can they be included Patients with celiac disease who can be controlled solely by diet
  • Uncontrolled complications, including but not limited to: persistent or active infection (except for the above HBV or HCV), symptomatic congestive heart failure, uncontrollable diabetes, uncontrollable hypertension, unstable angina pectoris, uncontrollable arrhythmia, active ILD, severe chronic GI disease with diarrhea, or suffering from a condition that may limit compliance with the study requirements Mental illness/social issue conditions that significantly increase the risk of AE or affect the subject's ability to provide written informed consent.
  • History of other primary malignant tumors, except for the following situations Malignant tumors that have been treated for the purpose of cure, and have no known active diseases for ≥ 5 years before the first administration of IP, with a low potential risk of recurrence
  • Fully treated non melanoma skin cancer or malignant lentiginous nevus without disease evidence Fully treated in situ cancer with no evidence of disease
  • History of meningeal cancer
  • History of active primary immunodeficiency
  • Active infection, including tuberculosis (clinical evaluation, including clinical history, physical examination and imaging examination results, as well as tuberculosis testing according to local clinical standards) or human immunodeficiency virus (HIV 1/2 antibody positive)
  • Patients who are co infected with HBV and HCV, or co infected with HBV and hepatitis D virus (HDV). (HBV infection refers to the presence of HBsAg and/or anti HBcAb, and detectable HBV DNA ≥ 10 IU/mL or according to local laboratory standards detection limit; HCV positive infection refers to detectable HCV RNA; HDV positive infection refers to the presence of anti HDV antibodies.)
  • Except for hair loss, vitiligo, and laboratory values specified in the inclusion criteria, any unrelieved NCI (National Cancer Institute) CTCAE v5.0 ≥ Level 2 events caused by previous anti-cancer treatment
  • Known to cause allergic or hypersensitive reactions to any investigational drug or any of its excipients
  • Have a history of allogeneic bone marrow transplantation and active chronic graft versus host disease
  • Have received anti PD-1, anti PD-L1, or anti CTLA-4 treatment before the first administration of IP
  • Previously received TACE (transcatheter arterial chemoembolization), TAE (transcatheter arterial embolization), or TARE (transcatheter arterial radioembolization)
  • Previously received systemic anti-cancer treatment for HCC
  • IP has been vaccinated with attenuated live vaccine within 30 days before the first administration. Note: If enrolled, patients are not allowed to receive attenuated live vaccines during IP treatment and within 30 days after the last administration of IP.
  • Currently in use or using immunosuppressive drugs within 14 days before the first dose of IP administration. This standard has the following exceptions:
  • Intranasal, inhalation, topical steroids, or local injection of steroids (such as intra-articular injection) Whole body corticosteroid therapy with no more than 10 mg/day prednisone or its equivalent physiological dose as a preventive use of steroid hormones for hypersensitivity reactions (such as CT scan pre-treatment medication)
  • Previously received IP allocation in this study
  • Simultaneously enroll in another clinical study, unless the study is an observational (non intervention) clinical study or during the follow-up period of an intervention study
  • Prior to randomization or treatment, participants had previously participated in clinical studies of immune checkpoint inhibitors, regardless of treatment group allocation.
  • From screening to 6 months after the last administration of IP, pregnant or lactating female patients, or male or female patients with fertility, are unwilling to use efficient contraceptive measures. According to the patient's preferred and habitual lifestyle, abstinence during treatment and abstinence is an acceptable contraceptive measure.
  • Patients who, in the judgment of the researcher, are unlikely to comply with the research steps, limitations, and requirements shall not participate in this study.

Trial locations and contacts

1 site in 1 country.

Huikai Li, MD contact

+8618622228639

tjchlhk@126.com

Yang Liu, MD contact

+8617694950696

China1 site, 1 recruiting

  • Tianjin Cancer Hospital Airport Hospital

    Tianjin, Tianjin Municipality, 300308

    Huikai Li, MD, 18622228639, tjchlhk@126.com

    Yang Liu, MD, 17694950696

    Recruiting

Other trials in China

About this study

Official title: Hepatic Arterial Infusion Chemotherapy (HAIC) Plus Tremelimumab, Durvalumab and Bevacizumab as Conversion Therapy for Potentially Resectable Hepatocellular Carcinoma (HCC): a Single Center, Open Label, Single Arm, Phase II Trial

To evaluate the efficacy and safety of HAIC combined with Durvalumab, Tremelimumab and Bevacizumab as first-line therapy in Unresectable hepatocellular carcinoma

Read the detailed description

An open label, single-arm, single center, phase II study evaluating HAIC combined with Durvalumab, Tremelimumab and Bevacizumab as first-line therapy in unresectable hepatocellular carcinoma

Being tested
HAIC+Durvalumab+Tremelimumab+Bevacizumab
Keywords
Unrescetable Hepatocellular Carcinoma, Durvalumab, Tremelimumab

What participants receive

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

  • HAIC+Durvalumab+Tremelimumab+BevacizumabDrug

    Tremelimumab：300mg, only once in cycle 1.Durvalumab: 1500mg, iv,q3w Bevacizumab: 15mg/kg, iv, q3w HAIC: Oxaliplatin plus Fluorouracil/Leucovorin

Study groups in NCT05864755
Study groupRoleWhat they receive
HAIC+Durvalumab+Tremelimumab+BevacizumabExperimentalNot described
Receives: Drug: HAIC+Durvalumab+Tremelimumab+Bevacizumab

What is being measured

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

  1. Overall response rate ( ORR) per RECIST 1.1

    Defined as proportion of patients who have a best response of CR or PR

    Measured: Up to 1 year

Secondary outcomes (5)

  1. Overall survival (OS)

    Defined as the time from enrollment to death from any cause

    Measured: Up to two years

  2. Progress Free Survival (PFS)

    Defined as the time from enrollment to disease progression or death (whichever occurs first)

    Measured: Up to two years

  3. Disease Control Rate (DCR) per RECIST 1.1

    Defined as proportion of patients who have CR or PR or SD

    Measured: Up to one year

  4. Duration of Response(DoR) per RECIST 1.1

    The time from the first assessment of the tumor as CR or PR to the second assessment as PD (Progressive Disease) or death from any cause

    Measured: Up to two years

  5. Time To Progress(TTP) per RECIST 1.1

    The time from the beginning to the first objective progression of the tumor

    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 posted18 May 2023
  2. Study start20 Jun 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2025 (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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05864755
Sponsor's protocol ID
L20230427
Status last verified
May 2023
First submitted
8 May 2023
Last updated
23 Aug 2023
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 HAIC+Durvalumab+Tremelimumab+Bevacizumab in people with Unrescetable Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital 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 23 inclusion and 40 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 23 Aug 2023. 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 Huikai Li, MD (+8618622228639, tjchlhk@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate ( ORR) per RECIST 1.1 (time frame: Up to 1 year). 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 NCT05864755.

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 23 Aug 2023.

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