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Hepatocellular CarcinomaPhase 2NCT06406634

Cadonilimab in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma

A Phase 2 study testing Cadonilimab and Lenvatinib in people with Hepatocellular Carcinoma, run by Hunan Cancer Hospital 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
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Trial summary

This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of Cadonilimab(AK104) in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma 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?
Cadonilimab and Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
15 May 2024to 20 Apr 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The written informed consent form should be signed before a subject participates in the trial；
  • Histologically/cytologically confirmed HCC or cirrhosis meeting the clinical diagnostic criteria of HCC by the American Association for the Study of Liver Diseases (AASLD)；
  • According to the Chinese Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 edition), eligible for China liver cancer staging (CNLC) Stage IIIa and is not suitable for radical treatment, such as resection, ablation, or liver transplantation. Suitable for HAIC surgery and chemotherapy drugs prescribed in advance by the research center, without any contraindications to HAIC surgery and chemotherapy drugs；
  • Child-Pugh A or B；
  • at least 1 measurable lesion according to RECIST v1.1；
  • Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1；
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  • Adequate organ and marrow function, as defined below； 1) Absolute neutrophil count (ANC) ≥1.5x109/L without granulocyte colony-stimulating factor in the last 14 days； 2) Platelets ≥75×109/L without transfusion in the last 14 days； 3) Hemoglobin ≥8.5 g/dL without transfusion or erythropoietin use in the last 14 days； 4) Serum total bilirubin (TBL) ≤2 × ULN； 5) AST and ALT ≤5× ULN； 6) Serum creatinine ≤1.5 × upper limit of normal (ULN)； Urine protein ≤(++) , or 24-hour urine protein quantification less than 1 g； 7) Good coagulation, defined as the international normalized ratio (INR) ≤ 2， or activated partial prothrombin time (PT) ≤ 1.5 times ULN；
  • a woman of childbearing potential (WOCBP) who is sexually active with a nonsterilized male partner must have a negative pregnancy test at the Screening visit (within 3 days before the first dose of the investigational product [Cycle 1 Day 1]). If a negative urine pregnancy test result cannot be confirmed, a blood pregnancy test will be requested. Females not of childbearing age were defined as being at least 1 year postmenopausal or having undergone surgical sterilization or hysterectomy；
  • If there is a risk of conception, all subjects (male or female) will be required to use contraception with an annual failure rate of less than 1% for the entire treatment period up to 120 days after administration of the study drug at the end of treatment；

Who cannot join

  • Containing components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma that have been previously confirmed by histology/cytology;
  • Recurrence of previous hepatocellular carcinoma；
  • Autoimmune hepatitis (requires liver puncture)
  • Have a history of hepatic encephalopathy or liver transplantation;
  • Diffuse liver cancer;
  • Symptomatic pleural effusion, ascites, and pericardial effusion that require drainage;
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  • History of kidney disease or nephrotic syndrome;
  • Presence of bleeding events from esophageal or gastric varices caused by portal hypertension within the past 6 months. Presence of known severe (G3) varicose veins in endoscopy within 3 months before the first dose. Evidence of portal hypertension (including the finding of splenomegaly in imaging studies) with a high risk of bleeding assessed by the investigator;
  • Any arterial/venous thromboembolic events within 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient cerebral ischemic attack, pulmonary embolism, deep vein thrombosis, or any other history of serious thromboembolism. Presence of implantable venous port or catheter-derived thrombosis, or superficial venous thrombosis, barring stable thrombosis following the conventional anticoagulation treatment. Prophylactic use of low-dose low-molecular-weight heparin is permitted;
  • Presence of any life-threatening bleeding events;
  • consecutive dosing of aspirin or other drugs, e.g., dipyridamole and clopidogrel, known to inhibit the platelet function before the first dose;
  • Uncontrolled hypertension (systolic greater than 140 mmHg or diastolic greater than 90 mmHg) after the optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy.
  • Symptomatic congestive cardiac failure (NYHA Class II-IV). Symptomatic or poorly controlled arrhythmia. History of congenital long QT syndrome or corrected Qtc > 500 ms (calculated using Fridericia formula) during screening.
  • History of gastrointestinal perforation and/or fistula, history of bowel obstruction (including incomplete bowel obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection accompanied with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea within the past 6 months.
  • Receipt of major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks before the first dose or having unhealed wounds, ulcers, or fractures. Receipt of tissue biopsy or other minor surgeries within 7 days before the first dose, barring venipuncture and catheterization for intravenous infusion.
  • History or current experience of pulmonary fibrosis and such lung diseases as interstitial pneumonia, pneumoconiosis, drug-related pneumonia, and severely impaired lung function.
  • Acute or chronic active hepatitis B or C infection
  • Active tuberculosis (TB), currently receiving anti-tuberculosis treatment or received such therapy within 1 year before the first dose.
  • Human immunodeficiency virus (HIV) infected (HIV 1/2 antibody positive) and known syphilis infection requiring treatment.
  • Active or poorly clinically controlled serious infections. Severe infections within 4 weeks before the first dose, including but not limited to hospitalization caused by infection, bacteremia, or severe pneumonia complication.
  • Receipt of immunosuppressants within 4 weeks before the first dose;
  • Receipt of a live attenuated vaccine within 4 weeks before the first dose or planned to receive a live attenuated vaccine during the study;
  • Receipt of systemic treatment with traditional Chinese medicines with cancer indications or immunomodulators (including thymosin, interferon, and interleukin, barring local use for controlling pleural fluid or ascites) within 2 weeks before the first dose;
  • Prior exposure to any agent targeting T cell costimulation or immune checkpoint pathways (e.g., anti-PD 1, anti-PD L1, anti-PD L2, anti-CTLA 4, anti CD137 or anti-OX40 antibody, etc).
  • Known allergy or reaction to any component of the Cadonilimab formulation;
  • Receipt of treatment in other clinical trials within 4 weeks before the first dose;
  • Pregnant or breastfeeding female patients;
  • Considered ineligible for participating in the trial by the investigator.

Trial locations and contacts

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

China1 site, 1 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Shanzhi Gu, 13574865998, gushanzhi@hnca.org.cn

    Recruiting

Other trials in China

About this study

This study is an open-label, multicenter, single-arm Phase II clinical study to evaluate the effectiveness of Cadonilimab(AK104) in Combination With Lenvatinib and Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma

Being tested
Cadonilimab, Lenvatinib
Keywords
Cadonilimab, Lenvatinib, Hepatic Arterial Infusion Chemotherapy (HAIC), Unresectable 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.

  • CadonilimabDrug

    Also called AK104

    Injectable solution

  • LenvatinibDrug

    capsule

Study groups in NCT06406634
Study groupRoleWhat they receive
Experimental: Cadonilimab +Lenvatinib+Hepatic Arterial Infusion Chemotherapy (HAIC)ExperimentalHAIC(FOLFOX)+Cadonilimab (AK104) (10 mg/kg, Q3W, iv) + Lenvatinib (8 mg (if patient body weight was <60 kg) or 12 mg (if patient body weight was ≥60 kg) )
Receives: Drug: Cadonilimab; Drug: Lenvatinib

What is being measured

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

  1. Objective Response Rate

    ORR is the proportion of patients with best response of complete response (CR) and PR

    Measured: from the first drug administration up to two years

Secondary outcomes (5)

  1. Progression-free Survival (PFS)

    Time from the date of first study treatment administration to the date of first documented tumor progression or death due to any cause, whichever occurs first

    Measured: Time Frame: from the first drug administration up to two years

  2. Disease Control Rate (DCR)

    Proportion of patients whose best overall response is either CR, PR, or SD

    Measured: from the first drug administration up to two years

  3. Duration of Response(DOR)

    Time from first documented response (CR or PR) until documented disease progression or death, whichever occurs first

    Measured: from the first drug administration up to two years

  4. Overall Survival(OS)

    Time from the date of first study treatment administration to the date of death due to any cause

    Measured: from the first drug administration up to two years

  5. Adverse event (AE)

    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results

    Measured: From the subject signs the ICF to 90 days after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first

Timeline

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

  1. First posted9 May 2024
  2. Study start15 May 2024 (estimated)
  3. Primary completion20 Apr 2026 (estimated)
  4. Study completion20 Apr 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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06406634
Sponsor's protocol ID
AK104-IIT-C-M-0035
Status last verified
May 2024
First submitted
7 Apr 2024
Last updated
9 May 2024
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 Cadonilimab and Lenvatinib in people with Hepatocellular Carcinoma, run by Hunan Cancer 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 9 inclusion and 28 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 9 May 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: from the first drug administration 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 NCT06406634.

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 9 May 2024.

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