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New treatment option for Advanced Hepatocellular Carcinoma (HCC)
Official title HAI or IV of Adebrelimab, Combined With Bevacizumab and HAI of FOLFOX for Advanced Unresectable Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT06737913
What this study is testing
What is intravenous infusion (IV) of Adebrelimab (ADE)?
intravenous infusion (IV) of Adebrelimab (ADE) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced hepatocellular carcinoma (hcc).
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 purpose of this study is to evaluate the efficacy and safety of Adabrelimab (arterial or intravenous administration) combined with hepatic artery FOLFOX infusion chemotherapy and Bevacizumab as the first-line treatment of advanced stage hepatocellular carcinoma. Patients will be randomized 1:1 etither to receive hepatic arterial infusion(HAI) Adabrelimab group or IV Adabrelimab group, and both groups will receive HAI FOLFOX chemotherapy and IV Bevacizumab.
- 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 and older
You may be able to join if
- Voluntarily participate in the study and sign the informed consent form;
- Aged ≥18 years (calculated as of the date of signing the informed consent form);
- Diagnosed with hepatocellular carcinoma (HCC) by clinical or pathological means;
- Barcelona Clinic Liver Cancer (BCLC) stage C, with vascular/bile duct invasion or distant metastasis (excluding cases with Vp4-type tumor thrombus);
- No prior systemic therapy for HCC; or progression or residual lesions following prior local therapy for HCC (including but not limited to surgery...
You likely can't join if
- Patients with a severe allergy to iodine contrast agents who are unable to undergo hepatic arterial infusion chemotherapy (HAIC);
- Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within one month prior to randomization;
- Active infections that cannot be effectively controlled;
- Severe gastroesophageal varices; untreated or incompletely treated gastroesophageal varices (with bleeding or high risk of bleeding);
- Presence of brain metastases or bone metastases requiring urgent surgical or radiotherapy intervention;
- Pregnant or suspected to be pregnant, or currently breastfeeding;
See the full eligibility criteria
- Voluntarily participate in the study and sign the informed consent form;
- Aged ≥18 years (calculated as of the date of signing the informed consent form);
- Diagnosed with hepatocellular carcinoma (HCC) by clinical or pathological means;
- Barcelona Clinic Liver Cancer (BCLC) stage C, with vascular/bile duct invasion or distant metastasis (excluding cases with Vp4-type tumor thrombus);
- No prior systemic therapy for HCC; or progression or residual lesions following prior local therapy for HCC (including but not limited to surgery, ablation, radiotherapy, or transarterial chemoembolization [TACE]), with...
- ECOG Performance Status (PS) score of 0-1 and Child-Pugh grade A or grade B with a score of 7;
- No history of autoimmune disease;
- An expected survival time of ≥3 months;
- At least one measurable lesion (per RECIST v1.1 criteria, the longest diameter of the measurable lesion on spiral CT scan must be ≥10 mm or the short axis of enlarged lymph nodes must be ≥15 mm; lesions previously...
- Sufficient hematologic, hepatic, and renal function, with laboratory tests within the following parameters performed within one week prior to enrollment:
- Neutrophil count ≥1.5×10\^9/L;
- Platelet count ≥75×10\^9/L;
- Hemoglobin ≥90 g/L;
- Serum ALT and AST ≤5×upper limit of normal (ULN); ⑤ Serum creatinine ≤1.5×ULN; ⑥ International Normalized Ratio (INR) \<2.3, or prothrombin time ≤ULN+6 seconds; ⑦ Albumin ≥30 g/L;
- Total bilirubin ≤3×ULN.
- Women of childbearing potential must have a negative serum or urine pregnancy test within seven days prior to study enrollment, must not be breastfeeding, and must agree to use contraceptive measures during the study...
- Patients with a severe allergy to iodine contrast agents who are unable to undergo hepatic arterial infusion chemotherapy (HAIC);
- Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within one month prior to randomization;
- Active infections that cannot be effectively controlled;
- Severe gastroesophageal varices; untreated or incompletely treated gastroesophageal varices (with bleeding or high risk of bleeding);
- Presence of brain metastases or bone metastases requiring urgent surgical or radiotherapy intervention;
- Pregnant or suspected to be pregnant, or currently breastfeeding;
- Current use or recent use (within 10 days before the initiation of the study treatment) of aspirin (\>325 mg/day, maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel, and cilostazol;
- Thrombotic or embolic events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, or cerebral infarction) or pulmonary embolism, occurring within six months prior to the...
- Congenital or acquired immunodeficiency;
- History of other malignant tumors;
- Any of the following conditions within 12 months prior to the initiation of the study: myocardial infarction, severe/unstable angina, or congestive heart failure;
- Renal insufficiency requiring dialysis;
- History of organ transplantation;
- Severe acute or chronic physical or mental illnesses or laboratory abnormalities that may increase study risks or interfere with result interpretation, rendering the patient unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lanzhou, Gansu, China; Guangzhou, Guangdong, China; Zhengzhou, Henan, 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.