Hepatocellular Carcinoma (HCC)Phase 2NCT07422753
A Prospective, Randomized Study of TACE Combined With Sintilimab, Bevacizumab, and Ipilimumab N01 Treating Advanced HCC
A Phase 2 study testing CTLA-4 Antibody(ipilimumab N01) in people with Hepatocellular Carcinoma (HCC), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary efficacy of a combination therapy involving TACE, sintilimab, bevacizumab, and ipilimumab N01 for the treatment of advanced hepatocellular carcinoma (HCC). 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?
- CTLA-4 Antibody(ipilimumab N01)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2026to Mar 2029
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign and date a written informed consent form prior to the implementation of any trial-related procedures.
- Patients with clinically confirmed unresectable or metastatic hepatocellular carcinoma (HCC).
- Male or female, ≥18 years old, ≤75 years old.
- ECOG Performance Status score of 0~1.
- Expected survival time >3 months.
- Barcelona Clinic Liver Cancer (BCLC) Stage B or C for unresectable HCC.
Show all 9Show fewer
- Suitable for Transarterial Chemoembolization (TACE) treatment.
- Child-Pugh score ≤7.
- At least one measurable lesion according to RECIST 1.1 criteria.
Who cannot join
- Previous histological/cytological confirmation of HCC with fibrolamellar, sarcomatoid, or cholangiocarcinoma components.
- History of liver transplantation or hepatic encephalopathy.
- Diffuse liver cancer.
- Inability to tolerate TACE or prior history of TACE treatment.
- Prior treatment with Transarterial Chemoembolization (TACE), Transarterial Embolization (TAE), or Transarterial Radioembolization (TARE).
- Prior systemic anti-tumor therapy or radiotherapy for HCC.
Show all 35Show fewer
- Portal vein main trunk tumor thrombus without adequate collateral circulation, or concurrent involvement of the superior mesenteric vein; inferior vena cava tumor thrombus.
- Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage.
- Any history of renal disease or nephrotic syndrome.
- History of esophageal or gastric variceal bleeding due to portal hypertension within the past 6 months; presence of severe (Grade 3) varices on endoscopy known within 3 months prior to first dose; evidence of portal hypertension (including splenomegaly on imaging) with high risk of bleeding as assessed by the investigator.
- Any life-threatening bleeding event within the past 3 months, requiring transfusion, surgery, local therapy, or continuous medication.
- Arterial or venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other severe thromboembolism. Except for catheter-related thrombosis from implanted ports or superficial venous thrombosis if stable under routine anticoagulation.
- Significant bleeding tendency or coagulopathy, or undergoing thrombolytic therapy.
- Prophylactic use of low-dose low molecular weight heparin (e.g., enoxaparin 40 mg/day) is allowed, but not vitamin K antagonists (e.g., warfarin).
- Requirement for long-term use of platelet function inhibitors such as aspirin, dipyridamole, or clopidogrel.
- Uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg despite optimal medical therapy), history of hypertensive crisis or hypertensive encephalopathy.
- Symptomatic congestive heart failure (New York Heart Association Class II-IV), symptomatic or poorly controlled arrhythmia, history of congenital long QT syndrome, or corrected QT interval (QTc) >500 ms on screening ECG (using Fridericia's formula).
- History of gastrointestinal perforation and/or fistula, intestinal obstruction (including incomplete obstruction requiring parenteral nutrition) within the past 6 months; extensive intestinal resection (partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic long-term diarrhea.
- Major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to first dose, or unhealed wounds, ulcers, or fractures; tissue biopsy or other minor surgical procedures within 7 days prior to first dose (except venous catheter placement for intravenous infusion).
- History or current presence of pulmonary diseases such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced pneumonia, or severe impaired lung function.
- Subjects with a history or ongoing Hepatitis C virus (HCV) infection are eligible. HCV-treated subjects must have completed treatment at least 1 month prior to start of study treatment. Subjects with Hepatitis B virus (HBV) are eligible if they meet the following: Patients with HBV viral load ≥10,000 IU/mL must receive anti-HBV therapy concurrent with HCC treatment; subjects on anti-HBV therapy with viral load <10,000 IU/mL should continue the same therapy throughout study treatment. Subjects who are anti-HBc positive, HBsAg negative, anti-HBs negative or positive, and with HBV viral load <10,000 IU/mL do not require anti-HBV prophylaxis.
- Active tuberculosis (TB), currently on anti-TB treatment or received anti-TB treatment within 1 year prior to first dose.
- Known human immunodeficiency virus (HIV) infection (positive HIV 1/2 antibodies), known syphilis infection.
- Active or poorly controlled severe infection. Severe infection within 4 weeks prior to first dose, including but not limited to hospitalization for infection complications, bacteremia, or severe pneumonia.
- Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is allowed. Known history of primary immunodeficiency. Subjects with only positive autoimmune antibodies should be evaluated by the investigator to confirm the absence of autoimmune disease.
- Use of immunosuppressive medication within 4 weeks prior to first dose, excluding intranasal, inhaled, topical corticosteroids, or systemic corticosteroids at physiologic doses (not exceeding 10 mg/day prednisone or equivalent). Temporary use of corticosteroids for conditions like asthma or COPD is allowed.
- Administration of a live attenuated vaccine within 4 weeks prior to first dose or planned during the study.
- Use of traditional Chinese medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin; except for local use to control pleural or ascitic fluid) within 2 weeks prior to first dose.
- Uncontrolled/uncorrectable metabolic disorders, other non-malignant organ/systemic diseases, or cancer-related sequelae that could lead to higher medical risk and/or uncertainty in survival evaluation.
- Diagnosis of other malignancies within 5 years prior to first dose, except for radically treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or carcinoma in situ. If diagnosis of other malignancy was more than 5 years prior, pathological/cytological diagnosis of recurrent/metastatic lesions is required.
- Prior treatment with any anti-PD-1 antibody, anti-PD-L1/L2 antibody, anti-CTLA-4 antibody, or other immunotherapy.
- Known allergy to Sintilimab, Bevacizumab, or their excipients, or history of severe hypersensitivity to other monoclonal antibodies.
- Treatment with other investigational agents within 4 weeks prior to first dose.
- Pregnant or breastfeeding female patients.
- Any other acute or chronic disease, psychiatric condition, or abnormal laboratory finding that, in the investigator's judgment, may increase the risk associated with study participation or study drug administration, or interfere with the interpretation of study results, and make the patient unsuitable for entry into this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Yuan Ding, 86+18858101960, dingyuan@zju.edu.cn
About this study
Official title: A Prospective, Single-Center, Randomized, Double-Blind Clinical Study of TACE Combined With Sintilimab, Bevacizumab, and Ipilimumab N01 in the Treatment of Advanced Hepatocellular Carcinoma
The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary efficacy of a combination therapy involving TACE, sintilimab, bevacizumab, and ipilimumab N01 for the treatment of advanced hepatocellular carcinoma (HCC). It also aims to explore the potential synergistic mechanisms of this combination. The main questions it aims to answer are:
Is the combination of TACE, sintilimab, bevacizumab, and ipilimumab N01 effective and safe for patients with advanced HCC? How do different sequencing schedules of ipilimumab N01 compare in terms of safety and efficacy? What potential biomarkers can predict treatment response?
Read more
Researchers will compare three different treatment groups:
Group A: Receives TACE and a single dose of ipilimumab N01 administered 3 weeks after the first dose of sintilimab and bevacizumab.
Group B: Receives TACE and a single dose of ipilimumab N01 administered concurrently with the first dose of sintilimab and bevacizumab.
Group C: Receives TACE, sintilimab and bevacizumab (without ipilimumab N01).
Participants will:
Be screened for eligibility and be randomly assigned to one of the three treatment groups.
Receive the assigned study treatment according to their group's schedule. Undergo regular clinic visits for safety checkups, tumor imaging assessments, and response evaluation using RECIST v1.1 and RECICL criteria.
Provide biological samples for exploratory biomarker analysis, including:
Peripheral blood at baseline and before each treatment cycle (every 3 weeks). Tumor biopsy specimens at baseline and 6 weeks after the first treatment. Surgical specimens if the patient undergoes conversion surgery.
Participate in follow-up visits:
A safety follow-up visit 30 days after the last study drug dose or before starting new anti-cancer therapy.
Subsequent survival follow-up contacts every 90 days to collect information on survival status and any subsequent anti-cancer treatments.
Read the detailed description
The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary efficacy of a combination therapy involving TACE, sintilimab, bevacizumab, and ipilimumab N01 for the treatment of advanced hepatocellular carcinoma (HCC). It also aims to explore the potential synergistic mechanisms of this combination. The main questions it aims to answer are:
Is the combination of TACE, sintilimab, bevacizumab, and ipilimumab N01 safe and tolerable for patients with advanced HCC? Does this combination therapy show preliminary efficacy in treating advanced HCC? How do different sequencing schedules of ipilimumab N01 (given 3 weeks after sintilimab vs. concurrently with sintilimab) compare in terms of safety and efficacy? What potential biomarkers can predict treatment response?
Researchers will compare three different treatment groups to assess the safety and efficacy of the combination and the role of ipilimumab N01 timing:
Group A: Receives a single dose of ipilimumab N01 (3mg/kg IV) administered 3 weeks after the first dose of sintilimab, in combination with sintilimab (200mg IV, Q3W), bevacizumab (15mg/kg IV, Q3W), and TACE.
Group B: Receives a single dose of ipilimumab N01 (3mg/kg IV) administered concurrently with the first dose of sintilimab, in combination with sintilimab (200mg IV, Q3W), bevacizumab (15mg/kg IV, Q3W), and TACE.
Group C: Receives sintilimab (200mg IV, Q3W), bevacizumab (15mg/kg IV, Q3W), and TACE (without ipilimumab N01).
Participants will:
Be screened for eligibility. Eligible participants (36 adults with advanced, previously untreated, unresectable or metastatic HCC) will provide informed consent and be randomly assigned to one of the three treatment groups (A, B, or C) using a central randomization system.
Receive the assigned study treatment according to their group's schedule. Undergo regular clinic visits for safety checkups, tumor imaging assessments (initially every 6 weeks, then every 12 weeks after 48 weeks), and response evaluation using RECIST v1.1 and RECICL criteria until disease progression, intolerable toxicity, or other study withdrawal criteria are met.
Provide biological samples for exploratory biomarker analysis, including:
Peripheral blood (10ml each time: 5ml in anticoagulant tube, 5ml in coagulant tube) at baseline and before each treatment cycle (every 3 weeks).
Tumor biopsy specimens at baseline and 6 weeks after the first treatment. Surgical specimens if the patient undergoes conversion surgery.
Participate in follow-up visits:
A safety follow-up visit 30 days (±7 days) after the last study drug dose or before starting new anti-cancer therapy (whichever comes first).
Subsequent survival follow-up contacts every 90 days (±7 days, which may be conducted via phone) to collect information on survival status and any subsequent anti-cancer treatments, until death, withdrawal of consent, or study closure.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- placebo, CTLA-4 Antibody(ipilimumab N01)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
The patient would receive placebo administered concurrently or 3 weeks after the first dose of sintilimab, in combination with sintilimab (200mg IV, Q3W), bevacizumab (15mg/kg IV, Q3W), and TACE.
CTLA-4 Antibody(ipilimumab N01)Drug
Also called IBI310
The patient would receive a single dose of ipilimumab N01 (3mg/kg IV) administered concurrently or 3 weeks after the first dose of sintilimab, in combination with sintilimab (200mg IV, Q3W), bevacizumab (15mg/kg IV, Q3W), and TACE.
| Study group | Role | What they receive |
|---|---|---|
| αCTLA-4 Combined with Delay | Experimental | Receives a single dose of ipilimumab N01 administered 3 weeks after the first dose of sintilimab and bevacizumab Receives: Drug: placebo; Drug: CTLA-4 Antibody(ipilimumab N01) |
| αCTLA-4 Combined Concurrently | Experimental | Receives a single dose of ipilimumab N01 administered concurrently with the first dose of sintilimab and bevacizumab Receives: Drug: placebo; Drug: CTLA-4 Antibody(ipilimumab N01) |
| No αCTLA-4 Combined | Placebo comparator | Receives sintilimab and bevacizumab without ipilimumab N01 Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR of Participants Assessed by RECIST1.1
Measured: Up to 6 months after randomization
Occurrence of Immune-Related Adverse Events Assessed by CTCAE v6.0
Measured: From the start of treatment to 6 months after the end of treatment
Secondary outcomes (6)
DCR of Participants Assessed by RECIST1.1
Measured: Up to 6 months after randomization
ORR of Participants Assessed by RECICL
Measured: Up to 6 months after randomization
PFS of Participants Assessed by RECIST1.1
Up to 24 months after randomization
Measured: Until disease progression
Overall survival(OS) of Participants
Measured: Up to 24 months after randomization
DOR of Participants Assessed by RECIST1.1
Measured: Up to 24 months after randomization
Occurrence of Adverse Events Assessed by CTCAE v6.0
Measured: From the start of treatment to 6 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start25 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2029 (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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422753
- Sponsor's protocol ID
- 2025-1454
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 24 Apr 2026
- 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Randomized, Double-Blind Clinical Study of TACE Combined With Sintilimab, Bevacizumab, and Ipilimumab N01 in the Treatment of Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07422753
- Acronym / sponsor ID
- 2025-1454
- Conditions
- Hepatocellular Carcinoma (HCC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 20 Feb 2026 (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.
The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary efficacy of a combination therapy involving TACE, sintilimab, bevacizumab, and ipilimumab N01 for the treatment of advanced hepatocellular carcinoma (HCC). It also aims to explore the potential synergistic mechanisms of this combination. The main questions it aims to answer are:
Is the combination of TACE, sintilimab, bevacizumab, and ipilimumab N01 effective and safe for patients with advanced HCC? How do different sequencing schedules of ipilimumab N01 compare in terms of safety and efficacy? What potential biomarkers can predict treatment response?
Researchers will compare three different treatment groups:
Group A: Receives TACE and a single dose of ipilimumab N01 administered 3 weeks after the first dose of sintilimab and bevacizumab.
Group B: Receives TACE and a single dose of ipilimumab N01 administered concurrently with the first dose of sintilimab and bevacizumab.
Group C: Receives TACE, sintilimab and bevacizumab (without ipilimumab N01).
Participants will:
Be screened for eligibility and be randomly assigned to one of the three treatment groups.
Receive the assigned study treatment according to their group's schedule. Undergo regular clinic visits for safety checkups, tumor imaging assessments, and response evaluation using RECIST v1.1 and RECICL criteria.
Provide biological samples for exploratory biomarker analysis, including:
Peripheral blood at baseline and before each treatment cycle (every 3 weeks). Tumor biopsy specimens at baseline and 6 weeks after the first treatment. Surgical specimens if the patient undergoes conversion surgery.
Participate in follow-up visits:
A safety follow-up visit 30 days after the last study drug dose or before starting new anti-cancer therapy.
Subsequent survival follow-up contacts every 90 days to collect information on survival status and any subsequent anti-cancer treatments.
Detailed description
The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary efficacy of a combination therapy involving TACE, sintilimab, bevacizumab, and ipilimumab N01 for the treatment of advanced hepatocellular carcinoma (HCC). It also aims to explore the potential synergistic mechanisms of this combination. The main questions it aims to answer are:
Is the combination of TACE, sintilimab, bevacizumab, and ipilimumab N01 safe and tolerable for patients with advanced HCC? Does this combination therapy show preliminary efficacy in treating advanced HCC? How do different sequencing schedules of ipilimumab N01 (given 3 weeks after sintilimab vs. concurrently with sintilimab) compare in terms of safety and efficacy? What potential biomarkers can predict treatment response?
Researchers will compare three different treatment groups to assess the safety and efficacy of the combination and the role of ipilimumab N01 timing:
Group A: Receives a single dose of ipilimumab N01 (3mg/kg IV) administered 3 weeks after the first dose of sintilimab, in combination with sintilimab (200mg IV, Q3W), bevacizumab (15mg/kg IV, Q3W), and TACE.
Group B: Receives a single dose of ipilimumab N01 (3mg/kg IV) administered concurrently with the first dose of sintilimab, in combination with sintilimab (200mg IV, Q3W), bevacizumab (15mg/kg IV, Q3W), and TACE.
Group C: Receives sintilimab (200mg IV, Q3W), bevacizumab (15mg/kg IV, Q3W), and TACE (without ipilimumab N01).
Participants will:
Be screened for eligibility. Eligible participants (36 adults with advanced, previously untreated, unresectable or metastatic HCC) will provide informed consent and be randomly assigned to one of the three treatment groups (A, B, or C) using a central randomization system.
Receive the assigned study treatment according to their group's schedule. Undergo regular clinic visits for safety checkups, tumor imaging assessments (initially every 6 weeks, then every 12 weeks after 48 weeks), and response evaluation using RECIST v1.1 and RECICL criteria until disease progression, intolerable toxicity, or other study withdrawal criteria are met.
Provide biological samples for exploratory biomarker analysis, including:
Peripheral blood (10ml each time: 5ml in anticoagulant tube, 5ml in coagulant tube) at baseline and before each treatment cycle (every 3 weeks).
Tumor biopsy specimens at baseline and 6 weeks after the first treatment. Surgical specimens if the patient undergoes conversion surgery.
Participate in follow-up visits:
A safety follow-up visit 30 days (±7 days) after the last study drug dose or before starting new anti-cancer therapy (whichever comes first).
Subsequent survival follow-up contacts every 90 days (±7 days, which may be conducted via phone) to collect information on survival status and any subsequent anti-cancer treatments, until death, withdrawal of consent, or study closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| αCTLA-4 Combined with Delay | Experimental | Drug: placebo, Drug: CTLA-4 Antibody(ipilimumab N01)Receives a single dose of ipilimumab N01 administered 3 weeks after the first dose of sintilimab and bevacizumab |
| αCTLA-4 Combined Concurrently | Experimental | Drug: placebo, Drug: CTLA-4 Antibody(ipilimumab N01)Receives a single dose of ipilimumab N01 administered concurrently with the first dose of sintilimab and bevacizumab |
| No αCTLA-4 Combined | Placebo comparator | Drug: placeboReceives sintilimab and bevacizumab without ipilimumab N01 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Sign and date a written informed consent form prior to the implementation of any trial-related procedures.
- Patients with clinically confirmed unresectable or metastatic hepatocellular carcinoma (HCC).
- Male or female, ≥18 years old, ≤75 years old.
- ECOG Performance Status score of 0~1.
- Expected survival time >3 months.
Key exclusion criteria (35 listed)
- Previous histological/cytological confirmation of HCC with fibrolamellar, sarcomatoid, or cholangiocarcinoma components.
- History of liver transplantation or hepatic encephalopathy.
- Diffuse liver cancer.
- Inability to tolerate TACE or prior history of TACE treatment.
- Prior treatment with Transarterial Chemoembolization (TACE), Transarterial Embolization (TAE), or Transarterial Radioembolization (TARE).
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 |
|---|---|---|
| placeboThe patient would receive placebo administered concurrently or 3 weeks after the first dose of sintilimab, in combination with sintilimab (200mg IV, Q3W), bevacizumab (15mg/kg IV, Q3W), and TACE. | Drug | No αCTLA-4 Combined, αCTLA-4 Combined Concurrently, αCTLA-4 Combined with Delay |
| CTLA-4 Antibody(ipilimumab N01)Also: IBI310The patient would receive a single dose of ipilimumab N01 (3mg/kg IV) administered concurrently or 3 weeks after the first dose of sintilimab, in combination with sintilimab (200mg IV, Q3W), bevacizumab (15mg/kg IV, Q3W), and TACE. | Drug | αCTLA-4 Combined Concurrently, αCTLA-4 Combined with Delay |
Primary outcome
ORR of Participants Assessed by RECIST1.1
Time frame: Up to 6 months after randomization
Occurrence of Immune-Related Adverse Events Assessed by CTCAE v6.0
Time frame: From the start of treatment to 6 months after the end of treatment
6 secondary outcomes
DCR of Participants Assessed by RECIST1.1
Time frame: Up to 6 months after randomization
ORR of Participants Assessed by RECICL
Time frame: Up to 6 months after randomization
PFS of Participants Assessed by RECIST1.1
Time frame: Until disease progression
Overall survival(OS) of Participants
Time frame: Up to 24 months after randomization
DOR of Participants Assessed by RECIST1.1
Time frame: Up to 24 months after randomization
Occurrence of Adverse Events Assessed by CTCAE v6.0
Time frame: From the start of treatment to 6 months after the end of treatment
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 24 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CTLA-4 Antibody(ipilimumab N01) in people with Hepatocellular Carcinoma (HCC), run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 9 inclusion and 35 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 24 Apr 2026. 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. Some participants in this study may receive a placebo. 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 Zhongquan Sun (86+13732233417, sunzq@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR of Participants Assessed by RECIST1.1 (time frame: Up to 6 months after randomization). The study lists 2 primary outcomes in all. 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 24 Apr 2026.