Hepatocellular Carcinoma (HCC)Phase 1TACE HCCNCT06990620
TACE Plus Ivonescimab for Unresectable Non-Metastatic HCC
A Phase 1 study testing TACE+AK112 in people with Hepatocellular Carcinoma (HCC), run by Fudan University.
Trial summary
This study is a single-arm, multicenter, prospective clinical trial designed to evaluate the efficacy and safety of Transarterial Chemoembolization (TACE) combined with envafolimab in patients with unresectable, non-metastatic hepatocellular carcinoma (HCC), while exploring potential biomarkers associated with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- TACE+AK112
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Dec 2027
- Phase
- Phase 1
- 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
- Age ≥18 years, male or female
- Patients with histologically or pathologically confirmed hepatocellular carcinoma (HCC), or Patients meeting the clinical diagnostic criteria for hepatocellular carcinoma as defined by the American Association for the Study of Liver Diseases (AASLD)
- BCLC Intermediate (B) or Advanced (C) stage, with liver-confined disease and ineligible for curative options (e.g., resection, transplant, or ablation)
- Child-Pugh Class A (score 5-6) or Class B (score 7)
- ECOG PS ≤1
- Measurable disease per RECIST 1.1 criteria
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- Life expectancy >12 weeks
- Adequate organ function meeting the following laboratory values: Hematological: Absolute neutrophil count (ANC) ≥1.5×10⁹/L Platelet count (PLT) ≥75×10⁹/L Hemoglobin (HGB) ≥90 g/L Hepatic: Total bilirubin (TBIL) ≤3× upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN Serum albumin ≥28 g/L Note: Patients may be enrolled if values stabilize after standard liver support therapy for ≥1 week, as assessed by the investigator. Renal: Serum creatinine (Cr) ≤1.5×ULN or Creatinine clearance ≥50 mL/min (calculated by Cockcroft-Gault formula) Coagulation: International normalized ratio (INR) ≤2×ULN or Activated partial thromboplastin time (APTT) ≤2×ULN
- Willing and able to provide written informed consent prior to any study-related procedures
Who cannot join
- Patients with histopathologically confirmed variant hepatocellular carcinoma (HCC) subtypes, including: Fibrolamellar hepatocellular carcinoma Sarcomatoid hepatocellular carcinoma Mixed hepatocellular-cholangiocarcinoma
- Prior local therapy targeting the index lesion(s), including but not limited to: Transarterial chemoembolization (TACE) Transarterial embolization (TAE) Transarterial radioembolization (TARE) Hepatic arterial infusion chemotherapy (HAIC) Radiofrequency ablation (RFA) Cryoablation High-intensity focused ultrasound (HIFU) Radiation therapy
- Prior systemic anti-cancer therapy for hepatocellular carcinoma, including but not limited to: Molecular targeted agents (e.g., tyrosine kinase inhibitors, anti-angiogenic drugs) Conventional chemotherapy Immunotherapy: Immune checkpoint inhibitors (e.g., PD-1/PD-L1/CTLA-4 inhibitors) Immune checkpoint agonists Cellular immunotherapy (e.g., CAR-T, NK cell therapy) Biological therapy: Cancer vaccines Cytokines (e.g., interferons, interleukins) Growth factor inhibitors
- Macrovascular invasion meeting either of the following criteria: Portal vein tumor thrombus (PVTT): Vp3: Tumor thrombus involving the first-order branches (left or right portal vein) Vp4: Tumor thrombus involving the main portal trunk or extending beyond Hepatic vein/inferior vena cava (IVC) tumor thrombus
- History of bleeding events within 6 months prior to initial treatment, including but not limited to: Acute hemorrhage from esophageal or gastric varices caused by portal hypertension AND/OR 6. Untreated or inadequately treated esophageal/gastric varices with high bleeding risk, as assessed by the investigator
- Clinically significant cardiovascular or cerebrovascular disease, including any of the following within 3 months prior to initial treatment: Congestive heart failure (NYHA Class ≥II) Myocardial infarction Cerebrovascular accident (stroke/TIA) Unstable arrhythmia Unstable angina OR 8. History of congenital long QT syndrome OR 9. Screening ECG showing QTc interval >500 ms (calculated by Fridericia's formula)
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- Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, immunosuppressants) within 2 years prior to initial treatment, with the following exceptions: Non-systemic replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal/pituitary insufficiency)
- Known HIV-positive status or history of active acquired immunodeficiency syndrome (AIDS)
- History of allogeneic stem cell transplantation or solid organ transplantation
- History of other active malignancies within 5 years prior to initial treatment, except for those with negligible risk of metastasis or death (e.g., 5-year overall survival rate >90%), including: Adequately treated carcinoma in situ of the cervix Non-melanoma skin cancer Localized prostate cancer (Gleason score ≤6, treated if required) Superficial bladder cancer (Ta/Tis, non-invasive)
- Women who are pregnant or breastfeeding
- Concurrent participation in another clinical trial, unless: It is a non-interventional study (e.g., observational/registry study), OR The patient is in the follow-up phase of an interventional trial, defined as: ≥4 weeks since last dose in the prior trial, OR ≥5 half-lives of the investigational drug (whichever is shorter)
- Systemic corticosteroid (>10 mg/day prednisone or equivalent) or other immunosuppressive therapy within 2 weeks prior to initial treatment, with the following exceptions: Adrenal replacement therapy (prednisone ≤10 mg/day or equivalent) Topical, ocular, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption Short-term corticosteroid prophylaxis for hypersensitivity reactions (e.g., premedication for CT scans)
- Any clinical or laboratory abnormality or compliance issue that, in the investigator's judgment, would preclude safe participation in the study
- Any condition that, in the investigator's opinion, may compromise patient safety or study integrity, including but not limited to: Clinically significant abnormal laboratory values not meeting specified thresholds Compliance concerns that may affect protocol adherence Other medical/psychosocial factors rendering the patient unsuitable for study participation
About this study
Official title: A Prospective, Multicenter, Single-Arm Study on the Efficacy and Safety of Transarterial Chemoembolization Combined With Ivonescimab in Unresectable, Non-Metastatic Hepatocellular Carcinoma
This study is a single-arm, multicenter, prospective clinical trial designed to evaluate the efficacy and safety of Transarterial Chemoembolization (TACE) combined with envafolimab in patients with unresectable, non-metastatic hepatocellular carcinoma (HCC), while exploring potential biomarkers associated with treatment response.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- TACE+AK112
- 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+AK112Combination product
TACE+AK112 (PD-1/VEGF bi-antibody, 20mg/kg, ivgtt, Q3W)
| Study group | Role | What they receive |
|---|---|---|
| TACE+AK112 | Experimental | Not described Receives: Combination Product: TACE+AK112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Disease assessments based on investigator assessments were determined by using RECIST version 1.1 guidelines. The ORR was defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions. The PR was defined as ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion.
Measured: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 54 weeks relative to the date of randomization and then every 12 weeks thereafter. Assessed up to maximum of approximately 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lunxiu Qin, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990620
- Sponsor's protocol ID
- Huashan011
- Acronym
- TACE HCC
- Status last verified
- May 2025
- First submitted
- 17 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm Study on the Efficacy and Safety of Transarterial Chemoembolization Combined With Ivonescimab in Unresectable, Non-Metastatic Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06990620
- Acronym / sponsor ID
- TACE HCC / Huashan011
- Conditions
- Hepatocellular Carcinoma (HCC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-arm, multicenter, prospective clinical trial designed to evaluate the efficacy and safety of Transarterial Chemoembolization (TACE) combined with envafolimab in patients with unresectable, non-metastatic hepatocellular carcinoma (HCC), while exploring potential biomarkers associated with treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE+AK112 | Experimental | Combination Product: TACE+AK112 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years, male or female
- Patients with histologically or pathologically confirmed hepatocellular carcinoma (HCC), or Patients meeting the clinical diagnostic criteria for hepatocellular carcinoma as defined by the American Association for the Study of Liver Diseases (AASLD)
- BCLC Intermediate (B) or Advanced (C) stage, with liver-confined disease and ineligible for curative options (e.g., resection, transplant, or ablation)
- Child-Pugh Class A (score 5-6) or Class B (score 7)
- ECOG PS ≤1
Key exclusion criteria (15 listed)
- Patients with histopathologically confirmed variant hepatocellular carcinoma (HCC) subtypes, including: Fibrolamellar hepatocellular carcinoma Sarcomatoid hepatocellular carcinoma Mixed hepatocellular-cholangiocarcinoma
- Prior local therapy targeting the index lesion(s), including but not limited to: Transarterial chemoembolization (TACE) Transarterial embolization (TAE) Transarterial radioembolization (TARE) Hepatic arterial infusion chemotherapy (HAIC) Radiofrequency ablation (RFA) Cryoablation High-intensity focused ultrasound (HIFU) Radiation therapy
- Prior systemic anti-cancer therapy for hepatocellular carcinoma, including but not limited to: Molecular targeted agents (e.g., tyrosine kinase inhibitors, anti-angiogenic drugs) Conventional chemotherapy Immunotherapy: Immune checkpoint inhibitors (e.g., PD-1/PD-L1/CTLA-4 inhibitors) Immune checkpoint agonists Cellular immunotherapy (e.g., CAR-T, NK cell therapy) Biological therapy: Cancer vaccines Cytokines (e.g., interferons, interleukins) Growth factor inhibitors
- Macrovascular invasion meeting either of the following criteria: Portal vein tumor thrombus (PVTT): Vp3: Tumor thrombus involving the first-order branches (left or right portal vein) Vp4: Tumor thrombus involving the main portal trunk or extending beyond Hepatic vein/inferior vena cava (IVC) tumor thrombus
- History of bleeding events within 6 months prior to initial treatment, including but not limited to: Acute hemorrhage from esophageal or gastric varices caused by portal hypertension AND/OR 6. Untreated or inadequately treated esophageal/gastric varices with high bleeding risk, as assessed by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TACE+AK112TACE+AK112 (PD-1/VEGF bi-antibody, 20mg/kg, ivgtt, Q3W) | Combination product | TACE+AK112 |
Primary outcome
Objective Response Rate (ORR)
Time frame: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 54 weeks relative to the date of randomization and then every 12 weeks thereafter. Assessed up to maximum of approximately 36 months.
Disease assessments based on investigator assessments were determined by using RECIST version 1.1 guidelines. The ORR was defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions. The PR was defined as ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TACE+AK112 in people with Hepatocellular Carcinoma (HCC), run by Fudan 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 9 inclusion and 15 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: opening soon, as of the sponsor's last update on 25 May 2025. 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 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.
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?
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) (time frame: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 54 weeks relative to the date of randomization and then every 12 weeks thereafter. Assessed up to maximum of approximately 36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2025.