AzTrials
AzTrials

Hepatocellular CarcinomaPhase 2NCT06361758

Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC

A Phase 2 study testing Cadonilimab+Lenvatinib in people with Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital at 3 sites in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This is an open-label, multi-center, single-arm, phase II study to evaluate the efficacy and safety of lenvatinib in combination with cadonilimab as second-line therapy in subjects with advanced hepatocellular carcinoma (HCC) who failed first-line standard therapy of immunotheray and antiangiogenic therapy. 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+Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesChina
Study dates
31 May 2024to 31 May 2027
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

  • Sign a written informed consent and be able to comply with the visit and related procedures required by the study protocol
  • Age 18-75 years old, Male of Female
  • ECOG PS 0-1
  • histologically/cytologically or clinically (according to Chinese guidelines for primary liver cancer diagnosis and treatment (2022) criteria) confirmed initial diagnosis of HCC
  • Not suitable for radical surgery and/or local treatment, BCLC stage C or stage B who failed local treatment
  • Patients who progressed on first-line standard system therapy (Atezolizumab plus bevacizumab, sintilimab combined with bevacizumab, or Camrelizumab and Apatinib, only these three regimenes) or with intolerable toxicity ( except for immunotherapy intolerance)
Show all 10Show fewer
  • Child Pugh A-B7
  • Expected survival time≥12 weeks
  • At least one measurable lesion (RECIST 1.1)
  • Enough organ and bone marrow function

Who cannot join

  • Fibrolamellar sarcomatoid or mixed cholangiocarcinoma-hepatocellular carcinoma.
  • Other anti-tumor therapies have been received after first-line systemic anti-tumor therapy.
  • Have history of hepatic encephalopathy, or a history of liver transplantation.
  • There are clinical symptoms requiring drainage of pleural fluid, ascites, pericardial effusion.
  • People with acute or chronic active hepatitis B or hepatitis C, hepatitis B virus (HBV) DNA > 2000IU/ml or 10^4 copies /ml; Hepatitis C virus (HCV) RNA > 10^3 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibodies were both positive.
  • Central nervous system metastasis.
Show all 12Show fewer
  • Previous bleeding from esophageal or fundus varices due to portal hypertension occurred within 6 months.
  • Autoimmune immune disease.
  • HIV infection.
  • Pregnant women.
  • The presence of any serious or uncontrolled systemic disease.
  • Other acute or chronic diseases, psychiatric disorders or abnormal laboratory test values that may lead to the following results: increasing the risk associated with research or drug administration, or interfering with the interpretation of research results. The Investigator considers that there are other potential risks that are not suitable for participation in the study.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Sun Yat-sen University Cancer Center)

    Guangzhou

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Eastern Hepatobiliary Surgery Hospital

    Shanghai

Other trials in China

About this study

Official title: Second-line Treatment With CAdonilimab and LEnvatinib for Unresectable HCC: A Single Arm, Multicenter, Phase II Trial. (SCALE)

This is an open-label, multi-center, single-arm, phase II study to evaluate the efficacy and safety of lenvatinib in combination with cadonilimab as second-line therapy in subjects with advanced hepatocellular carcinoma (HCC) who failed first-line standard therapy of immunotheray and antiangiogenic therapy.

Being tested
Cadonilimab+Lenvatinib
Keywords
cadonilimab (anti PD-1/CTLA-4 bispecific antibody)
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Cadonilimab+LenvatinibDrug

    Cadonilimab (AK104): 15mg/kg Q3W iv D1 + Lenvatinib: 8 mg (body weight <60 kg) or 12mg (body weight ≥60 kg) orally QD. Eligible patients will receive AK104 plus Lenvatinib until disease progression or withdrawn ICF or death, whichever comes first.

Study groups in NCT06361758
Study groupRoleWhat they receive
Cadonilimab+LenvatinibExperimentalNot described
Receives: Drug: Cadonilimab+Lenvatinib

What is being measured

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

  1. Objective Response Rate (ORR) per RECIST v1.1

    Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.

    Measured: Up to two years

Secondary outcomes (6)

  1. Objective Response Rate (ORR) per mRECIST

    Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to mRECIST.

    Measured: Up to two years

  2. Disease control Rate (DCR)

    Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1 and mRECIST respectively.

    Measured: Up to two years

  3. Duration of response (DoR)

    Defined as the time from the first dose to disease progression or death in patients who achieve complete or partial response.

    Measured: Up to two years

  4. Progression-Free-Survival (PFS)

    Defined as the time between signing the informed consent form to the disease progression (according to RECIST v1.1 criteria) or death due to any cause.

    Measured: Up to two years

  5. Overall survival Overall survival (OS)

    Defined as the time between the first dose to death due to any causes.

    Measured: Up to three years

  6. Incidence of Adverse Events

    Adverse events (AEs) ; serious adverse events (SAEs); Treatment related Adverse events (TRAEs); Use NCI-CTCAE version 5.0 for classification and grading.

    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 posted12 Apr 2024
  2. Study start31 May 2024 (estimated)
  3. Primary completion31 May 2026 (estimated)
  4. Study completion31 May 2027 (estimated)

Why it stopped: The PI has initiated a global multicenter Phase II clinical trial in the same direction, conducted by Akesobio.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06361758
Sponsor's protocol ID
B2023-326(2)
Status last verified
May 2025
First submitted
8 Apr 2024
Last updated
23 May 2025
Results posted
No
Data monitoring committee
Yes
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 Cadonilimab+Lenvatinib in people with Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital at 3 sites 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 12 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: withdrawn, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) per RECIST v1.1 (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 NCT06361758.

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 May 2025.

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