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New treatment option for Hepatocellular Carcinoma (HCC)
Official title A Prospective, Randomized Study of TACE Combined With Sintilimab, Bevacizumab, and Ipilimumab N01 Treating Advanced HCC
ClinicalTrials.gov ID: NCT07422753
What this study is testing
What is CTLA-4 Antibody(ipilimumab N01)?
CTLA-4 Antibody(ipilimumab N01) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma (hcc).
Also referred to as IBI310.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
Who can 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.
- Suitable for Transarterial Chemoembolization (TACE) treatment.
- Child-Pugh score ≤7.
- At least one measurable lesion according to RECIST 1.1 criteria.
What rules you out
- 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.
- 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...
- 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...
- 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...
- History of gastrointestinal perforation and/or fistula, intestinal obstruction (including incomplete obstruction requiring parenteral nutrition) within the past 6 months; extensive intestinal resection (partial...
- 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...
- History or current presence of pulmonary diseases such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-induced pneumonia, or severe impaired lung function.
- people with a history or ongoing Hepatitis C virus (HCV) infection are eligible. HCV-treated people must have completed treatment at least 1 month prior to start of study treatment. people with Hepatitis B virus (HBV)...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.