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Resectable Hepatocellular CarcinomaPhase 2NCT05578430

AK104 Combining With TACE for Resectable Hepatocellular Carcinoma (MORNING)

A Phase 2 study testing Cadonilimab, TACE and Surgery in people with Resectable Hepatocellular Carcinoma, run by Sun Yat-sen University.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a Phase 2, open-label, single-arm study of neoadjuvant immune-checkpoint blockade therapy (AK104) combining with TACE for resectable hepatocellular carcinoma. The purpose is to investigate the efficacy and safety of this therapeutic regimen to reduce the risk of postoperative recurrence in resectable HCC… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Resectable Hepatocellular Carcinoma
What is being tested?
Cadonilimab, TACE and Surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
No sites listed yet
Study dates
1 Jan 2023to 1 Jan 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years but ≤75 years
  • Resectable HCC staged BCLC A/B
  • Treatment naïve for HCC
  • High risk for recurrence, meeting at least one of the following criteria:
  • Multiple tumor lesions
  • Individual tumor > 5cm
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  • AFP > 400 ug/L
  • MVI positive based on preoperative MRI according to MVI predictive model of Radiomics
  • Measurable or evaluable lesions according to RECIST v1.1 criteria
  • ECOG performance status 0-1
  • Child-Pugh class A
  • Life expectancy ≥ 12 weeks
  • Adequate organ and marrow function as defined below:
  • Hemoglobin ≥9.0 g/dL
  • Absolute neutrophil count ≥ 1,500/μL
  • Platelets count ≥ 75,000/μL
  • Total serum bilirubin ≤ 1.5 ×upper limit of normal(ULN)
  • AST and ALT ≤ 5 × ULN, ALP ≤ 4 ×ULN
  • Serum creatinine ≤ 1.5 ×ULN
  • INR ≤ 1.5 ×ULN, APTT ≤ 1.5 ×ULN
  • Serum albumin ≥3.0 g/dL
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen as assessed by the treating investigator are eligible for this trial.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Any prior treatment for HCC.
  • Tumor rupture or bleeding. Suspected abdominal metastasis.
  • A major surgical procedure, open biopsy, or significant traumatic injury with poorly healed wound within 6 weeks prior to enrollment.
  • History of allogenic organ transplantation.
  • Under other clinical trials.
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion: vitiligo or alopecia, hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement, any chronic skin condition that does not require systemic therapy or celiac disease controlled by diet alone.
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  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to AK104 or other immune checkpoint inhibitors.
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection (including tuberculosis), uncontrolled hypertension (defined as blood pressure of > 140/90 mmHg during the screening period despite medical management), interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.
  • History of hepatic encephalopathy, refractory ascites or esophagogastric varices with high risk of bleeding. Upper gastrointestinal hemorrhage within the year prior to the first dose of study drug.
  • Active hepatitis B infection without treatment (positive HBV surface antigen (HBsAg) and HBV DNA ≥ 1000 IU/ml). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Active hepatitis C infection (positive HCV antibody and HCV RNA above the lower limit of detection).
  • A primary brain tumor (excluding meningiomas and other benign lesions), any brain metastases, leptomeningeal disease, seizure disorders not controlled with standard medical therapy, or history of a stroke within the year prior to the first dose of study drug.
  • History of active primary immunodeficiency.
  • History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study agent. The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection). Systemic corticosteroids at physiologic doses that do not exceed 10 mg/day of prednisone or its equivalent. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of study drug. Note: Patients, if enrolled, should not receive live vaccine whilst receiving study drug and for at least 30 days after the last dose of study agent.
  • Systemic immunostimulant therapy within 14 days prior to the first dose of study agent.
  • History of serious systemic disease, including myocardial infarction or unstable angina within the 12 months prior to the first dose of study drug, hypertensive crisis or hypertensive encephalopathy, New York Heart Association (NYHA) grade II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication, significant vascular disease or symptomatic peripheral vascular disease.
  • History of coagulopathy, bleeding diathesis, or thrombosis within the 12 months prior to the first dose of study drug.
  • A serious, non-healing wound, ulcer, or bone fracture.
  • Pregnancy or lactation.
  • Total parenteral nutrition.
  • Exclusion from the study by the judgement of investigators, due to some factors that may lead to the forced termination of the study, including other acute, chronic or psychological disease.

Trial locations and contacts

No sites are listed yet.

Kuang Ming, Ph.D. contact

008687755766 ext. 8576

kuangm@mail.sysu.edu.cn

About this study

Official title: Neoadjuvant Immune-Checkpoint Blockade Therapy Combining With TACE For Resectable Hepatocellular Carcinoma With High Recurrence Risk: A Phase II, Single-arm Clinical Trial

This is a Phase 2, open-label, single-arm study of neoadjuvant immune-checkpoint blockade therapy (AK104) combining with TACE for resectable hepatocellular carcinoma. The purpose is to investigate the efficacy and safety of this therapeutic regimen to reduce the risk of postoperative recurrence in resectable HCC patients with a high risk of recurrence.

Read the detailed description

The trial will recruit 54 patients. At the first step, 26 patients will be recruited. Only when at least 10 patients achieve major pathological response after surgery will the trial enter the second step and continue to recruit other patients. After being enrolled, all patients giving written informed consent will receive TACE plus 2-cycle of Cadonilimab treatment before surgery. Four weeks later after surgery, Cadonilimab treatment will be followed up to 16 cycles. The tumor response evaluation will be conducted on a regular basis until progression of disease. Long-term survival follow up will be conducted as well.

Being tested
Cadonilimab, TACE, Surgery
Keywords
Resectable Hepatocellular Carcinoma, Neoadjuvant Treatment, Immune-checkpoint Blockade, TACE

What participants receive

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

  • CadonilimabDrug

    Also called AK104

    10mg/kg by intravenous infusions every 3 weeks

  • TACEProcedure or surgery

    TACE will be performed per institutional standard of care.

  • SurgeryProcedure or surgery

    Surgery will be performed per institutional standard of care.

Study groups in NCT05578430
Study groupRoleWhat they receive
TACE+Cadonilimab+SurgeryExperimentalAfter appropriate screening and randomization, patients enrolled will receive TACE plus 2-cycle of Cadonilimab treatment before surgery. Four weeks later after surgery, Cadonilimab treatment will be followed up to 16 cycles.
Receives: Drug: Cadonilimab; Procedure: TACE; Procedure: Surgery

What is being measured

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

  1. Major Pathological Response Rate (MPR rate)

    MPR rate is defined as the percentage of patients with over 90% of histological tumor tissue necrosis removed after neoadjuvant TACE combined with AK104 treatment.

    Measured: Up to 2 years

Secondary outcomes (3)

  1. 1-year recurrence rate

    Up to 1 years

    Measured: The percentage of patients who suffer recurrence one year after surgery.

  2. Objective response rate (ORR)

    Up to 2 years

    Measured: ORR is defined as the percentage of patients who have achieved complete response (CR) or partial response (PR), as measured by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, after neoadjuvant TACE combined with AK104 treatment but before

  3. Incidence of Adverse Events (AE)

    Up to 2 years

    Measured: The percentage of patients who suffer grade 3 or worse adverse events from the first dose of administration to last follow-up, assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Timeline

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

  1. First posted13 Oct 2022
  2. Study start1 Jan 2023 (estimated)
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion1 Jan 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
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05578430
Sponsor's protocol ID
HCC2022
Status last verified
Dec 2022
First submitted
11 Oct 2022
Last updated
15 Dec 2022
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 Cadonilimab, TACE and Surgery in people with Resectable Hepatocellular Carcinoma, run by Sun Yat-sen University.

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 24 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: status not confirmed, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

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 Kuang Ming, Ph.D. (008687755766 ext. 8576, kuangm@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Pathological Response Rate (MPR rate) (time frame: Up to 2 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 NCT05578430.

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 15 Dec 2022.

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