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AzTrials

Hepatocellular Carcinoma Non-resectablePhase 1/2NCT06040177

Efficacy and Safety of SBRT Combined With Cardonilizumab and Lenvastinib in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus

A Phase 1/2 study testing Cadonilimab, Stereotactic radiotherapy and Renvatinib in people with Hepatocellular Carcinoma Non-resectable and Portal Vein Tumor Thrombus, run by First Affiliated Hospital of Guangxi Medical University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is a single-arm, multicenter clinical study to evaluate the efficacy and safety of SBRT combined with cardonilizumab and lenvastinib in the treatment of unresectable hepatocellular carcinoma with portal vein tumor thrombus Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Cadonilimab, Stereotactic radiotherapy and Renvatinib
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
2 Feb 2023to 1 Feb 2025
Phase
Phase 1/2
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18-70 years old;
  • Eastern Cooperative Oncology Group (ECOG) -Performance Status(PS):0-2 points；
  • Hepatocellular carcinoma was diagnosed according to histopathology or the 2022 diagnostic criteria for primary liver cancer；
  • Expected survival period≥3 months;
  • Liver function grade Child-Pugh A or better grade B (7 points);
  • At least one measurable lesion:
Show all 11Show fewer
  • Liver lesion ① The Lesion can be accurately measured at least in the range of 1.0cm;
  • ② The Lesion is suitable for repeated measurement;
  • The lesion shows enhanced intratumoral arteries on computed tomography (CT) or magnetic resonance imaging (MRI); Non-liver lesion In at least one dimension, the short axis of lymphadenopathy (LN) is≥1.5cm. Longest diameter of non-nodular lesions is≥1.0cm
  • The Barcelona liver cancer staging system is stage C (BCLC-C), which meets one of the following conditions:
  • Liver tumor can be resected, which is combined with Vp 3-4 portal vein cancer thrombus; (2) Liver tumor is unresectable or has distant metastasis, and is combined with Vp1-4 type portal vein cancer thrombus; 8. The patient had not received prior systemic therapy including sorafenib, lenvatinib, chemotherapy; 9. The patient had previously received locoregional therapy (including radiofrequency or ablation therapy, percutaneous ethanol or acetic acid injection, cryotherapy, high intensity focused ultrasound, hepatic artery chemoembolization, hepatic artery embolization, etc., and the local treatment area had definite progression (according to RECIST v1.1 criteria); 10. Baseline blood routine and biochemical indicators meet the following criteria: Hemoglobin≥90g / L; Absolute neutrophil count (ANC)≥1.5× 10 ^ 9 / L; Platelet≥75×10 ^ 9 / L; ALT,AST ≤3×upper normal value (ULN); Serum total bilirubin ≤ 1.5 ×ULN; Serum creatinine ≤1.5 × ULN; Serum albumin was used for≥30g / L.

Who cannot join

  • Patients diagnosed with hepatobiliary duct cell carcinoma, mixed cell carcinoma, or fibrolaminar cell carcinoma；
  • Patients with a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation or planned transplantation；
  • Patients have hepatic encephalopathy (West Haven Standard Grade III, Level IV) or have moderate or severe ascites (i.e., patients requiring therapeutic puncture drainage) or have uncontrolled pleural or pericardial effusion；
  • Patients have symptomatic, untreated, or progressive central nervous system (CNS) or leptomeningeal metastases.If all the following criteria are met, asymptomatic subjects with treated CNS lesions can be enrolled.

Trial locations and contacts

1 site in 1 country.

Ning Mo, professor contact

15289662269

369895025@qq.com

China1 site, 1 recruiting

  • First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

    ning mo, 15289662269, 369895025@qq.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of SBRT Combined With Cardonilizumab and Lenvastinib in the Treatment of Unresectable Hepatocellular Carcinoma With Portal Vein Tumor Thrombus#a Prospective, Multicenter, Single-arm Clinical Study

This study is a single-arm, multicenter clinical study to evaluate the efficacy and safety of SBRT combined with cardonilizumab and lenvastinib in the treatment of unresectable hepatocellular carcinoma with portal vein tumor thrombus

Being tested
Cadonilimab, Stereotactic radiotherapy, Renvatinib
Keywords
Hepatocellular Carcinoma, portal vein tumor thrombus, Immune Checkpoint Inhibitors, Efficacy
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

    Cadonilimab will be administered within 2 weeks after the completion of the radiotherapy treatment once every 3 weeks (Q3W), for up to 2 years

  • Stereotactic radiotherapyRadiation

    Radiation therapy: Stereotactic radiotherapy (5-8Gy*5F) for portal vein thrombus within 21 days after entry

  • RenvatinibDrug

    Renvatinib: 8mg (weight <60kg) or 12mg (weight 60kg) once a day until disease progression, intolerable toxicity

Study groups in NCT06040177
Study groupRoleWhat they receive
SBRT+cardonilizumab+lenvastinib GroupExperimentalRenvatinib: 8mg (weight <60kg) or 12mg (weight ≥60kg) once a day until disease progression, intolerable toxicity Radiation therapy: Stereotactic radiotherapy (5-8Gy*5F) for portal vein thrombus within 21 days after entry Cadonilimab will be administered within 2 weeks after the completion of the radiotherapy treatment once every 3 weeks (Q3W), for up to 2 years
Receives: Drug: Cadonilimab; Radiation: Stereotactic radiotherapy; Drug: Renvatinib

What is being measured

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

  1. Objective response rate(ORR)

    ORR is proportion of patients with complete response(CR) or partial response(PR) assessed by investigators according to RECIST v1.1.

    Measured: Up to approximately 2 years

Secondary outcomes (5)

  1. 3-month PFS rate

    3-month PFS rate is the percentage of patients whose disease has not progressed within 3 months.

    Measured: Up to approximately 2 years

  2. progression-free survival (PFS)

    Progression-free survival (PFS) is defined as the time from the first dose of Cadonilimab until documentation of PD (as per RECIST v1.1) or death due to any cause, whichever occurs first.

    Measured: Up to approximately 2 years

  3. Disease control rate (DCR)

    DCR is proportion of patients with complete response, partial response or stable disease assessed by investigators according to RECIST v1.1.

    Measured: Up to approximately 2 years

  4. Duration of response (DOR)

    Duration of Response (DOR) is defined as the time between the first assessment of a tumor as Complete Response（CR）or Partial Response（PR）and the first assessment of Progressive Disease (PD) or death from any cause.

    Measured: Up to approximately 2 years

  5. Overall Survival (OS)

    Overall survival (OS) is defined as the time from the first dose of Cadonilimab until death due to any cause

    Measured: Up to approximately 2 years

Timeline

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

  1. First posted15 Sep 2023
  2. Study start2 Feb 2023
  3. Primary completion2 Feb 2023
  4. Study completion1 Feb 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 1/2
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
NCT06040177
Sponsor's protocol ID
GuangxiMUMJ1
Status last verified
Sep 2023
First submitted
13 Jul 2023
Last updated
15 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Liang X, Li Y, Liang M, Zeng Z, Hu K, Yang L, Yan H, Li M, Zeng J, Tang J, Lv Y, Liang L, Meng J, Su H, Ma J, Mo N. Association between gut microbiota characteristics and therapeutic efficacy of multimodal combination therapy in hepatocellular carcinoma with portal vein tumor thrombus: a secondary analysis of a prospective phase II trial. Front Immunol. 2026 Aug 18;17:1864941. doi: 10.3389/fimmu.2026.1864941. eCollection 2026.

    PubMed 42682622

  • Mo N, Hu K, Zeng Z, Yang L, Fang Y, Zeng J, Li Y, Yang Z, Tang J, Zhang T, Ma F, Liu C, Zheng H, Qiu J, Jiang Y, Lv Y, Liang L, Huang X, Liao X, Wang Y, Lu X, Ning L, Lao Guo S, Ma J, Wang R. Stereotactic body radiation therapy combined with cadonilimab and lenvatinib in the treatment of hepatocellular carcinoma with Vp3 or Vp4 portal vein tumor thrombus: a prospective, multicenter, single-arm, phase II clinical trial. Front Immunol. 2025 Nov 10;16:1687344. doi: 10.3389/fimmu.2025.1687344. eCollection 2025.

    PubMed 41293180

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cadonilimab, Stereotactic radiotherapy and Renvatinib in people with Hepatocellular Carcinoma Non-resectable and Portal Vein Tumor Thrombus, run by First Affiliated Hospital of Guangxi Medical University 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 11 inclusion and 4 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 Sep 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Ning Mo, professor (15289662269, 369895025@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate(ORR) (time frame: Up to approximately 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 NCT06040177, which also lists 2 linked publications.

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 Sep 2023.

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