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Hepatocellular Carcinoma (HCC)Phase 2NCT07154082

Apatinib Mesylate and Camrelizumab Combined With TACE as Neoadjuvant Therapy for Hepatocellular Carcinoma

A Phase 2 study testing TACE (transarterial chemoembolization) combined with targeted/immunotherapy in people with Hepatocellular Carcinoma (HCC), run by Wei Zhang 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 a prospective, single-arm, phase Ⅱtrial. The subjects are patients resectable centrally-located hepatocellular carcinoma in BCLC stage B who are admitted to the Hepatobiliary Surgery Department of Tongji Hospital , Tongji Medical College, Huazhong University of Science and Technology, are over 18 years… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatocellular Carcinoma (HCC)
What is being tested?
TACE (transarterial chemoembolization) combined with targeted/immunotherapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteChina
Study dates
30 Dec 2025to 31 Jul 2028
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1) Diagnosed with hepatocellular carcinoma by pathological or histological examination.
  • 2) the patient do not receive any anti-tumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy and targeted therapy
  • 3)resectable centrally-located hepatocellular carcinoma in BCLC stage B; Surgical resection was feasible after MDT discussion.
  • 4) aged 18 to 70 years old, male or female
  • 5) at least one measurable lesions (according to RECISTv1.1 requirements, The long diameter of the measurable lesion in the spiral CT scan is ≥10 mm or The short diameter of the enlarged lymph nodes is ≥15 mm)
  • 6) ECOG score between 0 to 2, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤5 ULN, total serum bilirubin TBIL ≤1.5 ULN, creatinine (Cr)≤1.5ULN, HB≥80g/L, neutrophil > 1.5×109/L ,Serum albumin > 28 g/L
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  • 7) Child - Pugh grade A or B (7 points or less); ICG - R15 < 20%
  • 8) Sufficient future liver reserve (FLR): For patients with liver cirrhosis, FLR should be greater than 40% of the standard liver volume; for patients without liver cirrhosis, FLR should be greater than 30% of the standard liver volume.
  • 9) After assessment, TACE treatment can be deemed suitable.
  • 10) The subjects signed the informed consent form and voluntarily received the neoadjuvant treatment of Apatinib mesylate and Carlimzumab combined with TACE. They had good compliance and cooperated with the follow-up.

Who cannot join

  • 1) Patients with intrahepatic cholangiocarcinoma (ICC), mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma.
  • 2) Patients with a history of malignant tumors other than liver cancer.
  • 3) Patients with recurrent HCC after surgery who have received local or systemic treatment (chemotherapy, radiotherapy, surgery, interventional therapy, ablation, alcohol injection, or molecular targeted therapy).
  • 4) Patients who are currently receiving or have previously received organ transplantation or allogeneic bone marrow transplantation, or have immune deficiency diseases or a history of organ transplantation.
  • 5) Patients with vascular or biliary tumor thrombus or extrahepatic organ metastasis as shown by imaging.
  • 6) Patients with moderate to severe ascites requiring therapeutic puncture and drainage or uncontrolled pleural effusion or pericardial effusion.
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  • 7) Patients with dysfunction of cardiovascular, respiratory, nervous, digestive, or urinary systems.
  • 8) Patients with a history of gastrointestinal bleeding within 6 months before the start of the study, with a tendency to gastrointestinal bleeding, abdominal fistula, gastrointestinal perforation, or abdominal abscess.
  • 9) Patients with multiple factors affecting oral drug administration (such as inability to swallow, chronic diarrhea, and intestinal obstruction, which significantly affect drug intake and absorption); patients allergic to the active ingredients or excipients of Camrelizumab and Apatinib mesylate.
  • 10) Pregnant or lactating women; patients with reproductive capacity who are unwilling or unable to take effective contraceptive measures.
  • 11) Patients with mental disorders or a history of abuse of psychotropic drugs.
  • 12) Patients who have experienced thrombosis or embolism events within 6 months before the start of the study, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.
  • 13) Patients without legal capacity or with restricted legal capacity.
  • 14) Patients with any other conditions that the investigator deems unsuitable for participation in this trial.

Trial locations and contacts

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

WeiZhang, MD contact

086-13986029425

weizhangtjh@hust.edu.cn

China1 site, 1 recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

    WeiZhang, MD, 086-13986029425, weizhangtjh@hust.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Single-arm, Phase Ⅱ Study of Apatinib Mesylate and Camrelizumab Combined With TACE as Neoadjuvant Therapy for Resectable Centrally-located Hepatocellular Carcinoma in BCLC Stage B

This study is a prospective, single-arm, phase Ⅱtrial. The subjects are patients resectable centrally-located hepatocellular carcinoma in BCLC stage B who are admitted to the Hepatobiliary Surgery Department of Tongji Hospital , Tongji Medical College, Huazhong University of Science and Technology, are over 18 years old, and have signed the informed consent form to voluntarily participate in this study. Through the neoadjuvant treatment of Apatinib mesylate and Camrelizumab combined with TACE before liver resection, it is expected to reduce the tumor size, lower the tumor burden, increase the surgical margin, improve the R0 resection rate, decrease the postoperative recurrence risk, and prolong the overall survival.

Being tested
TACE (transarterial chemoembolization) combined with targeted/immunotherapy
Keywords
TACE, Hepatocellular carcinoma, Camrelizumab, apatinib, neoadjuvant therapy
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • TACE (transarterial chemoembolization) combined with targeted/immunotherapyDrug

    Patients in the neoadjuvant treatment group will receive TACE treatment within one week after enrollment. One week after the resolution of the TACE treatment syndrome, they will be given Camrelizumab (200 mg, once every two weeks, for a total of 4 cycles) and oral Apatinib mesylate tablets (250 mg, once a day, for a total of 2 months).To ensure surgical safety, Camrelizumab should be discontinued at least two weeks before surgery, while Apatinib should be discontinued at least one week before surgery.

Study groups in NCT07154082
Study groupRoleWhat they receive
TACE combined with Camrelizumab and ApatinibExperimentalPatients in the neoadjuvant treatment group will receive TACE treatment within one week after enrollment. One week after the resolution of the TACE treatment syndrome, they will be given Camrelizumab (200 mg, once every two weeks, for a total of 4 cycles) and oral Apatinib mesylate tablets (250 mg, once a day, for a total of 2 months).To ensure surgical safety, Camrelizumab should be discontinued at least two weeks before surgery, while Apatinib should be discontinued at least one week before surgery.
Receives: Drug: TACE (transarterial chemoembolization) combined with targeted/immunotherapy

What is being measured

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

  1. Two-year disease-free survival rate

    DFS is defined as the time from surgical resection to local recurrence.

    Measured: From the time of undergoing the surgery to two years later

Secondary outcomes (7)

  1. ORR

    It refers to the proportion of patients whose tumors have shrunk to a certain extent and maintained that state for a certain period of time (mainly for solid tumors), including cases of complete response (CR, Complete Response) and partial response (PR, Partial Response).

    Measured: The period from the onset of therapeutic effect until the confirmation of tumor progression，up to 24 months

  2. MPR

    The residual surviving tumor tissue is ≤ 30%.

    Measured: max 24 months

  3. TTR

    TTR is defined as the time from the start of treatment until the first objectiveobservation of a response (either partia response, PR,or complete responseCR),provided that the response is subsequently confirmed

    Measured: max 24 months

  4. OS

    OS is defined as the time from study treatment to the date of death of thesubject, regardless of the cause of death.

    Measured: max 24 months

  5. DCR

    The proportion of patients who achieve complete response (CR) , partial response (PR) , or stable disease (SD) for a specified minimum duration according to standardized response criteria

    Measured: max 24 months

  6. R0 resection rate

    The proportion of cases where the tumor is completely removed and the microscopic margins are negative, meaning there is no tumor residue remaining.

    Measured: max 24 months

  7. AE

    Adverse events (AEs), Serious Adverse events (SAEs), surgery related safety.

    Measured: max 24 months

Timeline

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

  1. First posted4 Sep 2025
  2. Study start30 Dec 2025 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Jul 2028 (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
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07154082
Sponsor's protocol ID
HCC-001
Status last verified
Aug 2025
First submitted
12 Aug 2025
Last updated
4 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TACE (transarterial chemoembolization) combined with targeted/immunotherapy in people with Hepatocellular Carcinoma (HCC), run by Wei Zhang 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 10 inclusion and 14 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 4 Sep 2025. 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?

Contact WeiZhang, MD (086-13986029425, weizhangtjh@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Two-year disease-free survival rate (time frame: From the time of undergoing the surgery to two years later). 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 NCT07154082.

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 4 Sep 2025.

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