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New treatment option for Carcinoma, Hepatocellular
Official title Adjuvant Adebrelimab Plus Apatinib for Participants With HCC at High-risk of Recurrence After Curative Resection
ClinicalTrials.gov ID: NCT06454578
What this study is testing
What is Adebrelimab + Apatinib?
Adebrelimab + Apatinib is an investigational medicine, being studied as a potential treatment for carcinoma, hepatocellular.
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
- This is a single-center, single-arm, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib as adjuvant therapy in hepatocellular carcinoma (HCC) participants who are at high risk of recurrence after curative resection.
- Phase 2: a mid-size study of how well it works
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
- Participants must meet all of the following conditions in order to be enrolled in this study:
- Voluntarily participate in this study and sign an informed consent form.
- Participants diagnosed with HCC through pathological histology/cytology or clinically diagnosed with HCC according to the Diagnosis and Treatment...
- Within 4-12 weeks prior to enrollment, radical resection surgery was performed.
- Complete recovery from surgical resection within 4 weeks prior to enrollment.
You likely can't join if
- If a subject meets any of the following conditions, they will not be allowed to enter this study:
- Known hepatobiliary carcinoma, sarcoma like hepatocellular carcinoma, combined hepatocellular-cholangiocarcinoma，and fibrous layer cell carcinoma...
- There are uncontrollable extrahepatic metastases, such as lung and brain metastases (EHS).
- Previously received local treatment, including therapeutic TACE, transarterial embolization (TAE), hepatic artery infusion chemotherapy (HAIC)...
- Participants who are preparing to undergo or have previously received organ or allogeneic bone marrow transplantation.
- Participants who are currently accompanied by interstitial pneumonia or interstitial lung disease, or have a history of interstitial pneumonia or...
See the full eligibility criteria
Who can join
- Participants must meet all of the following conditions in order to be enrolled in this study:
- Voluntarily participate in this study and sign an informed consent form.
- Participants diagnosed with HCC through pathological histology/cytology or clinically diagnosed with HCC according to the Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 Edition).
- Within 4-12 weeks prior to enrollment, radical resection surgery was performed.
- Complete recovery from surgical resection within 4 weeks prior to enrollment.
- High risk factors for postoperative recurrence of hepatocellular carcinoma include multiple tumors, tumor length\>5 cm, poor tumor differentiation (Edmondson III-IV grade), margin ≤ 1 cm, invasion of Microvasculature or...
- Child Pugh liver function rating within 7 days prior to randomization: A or B (≤ 7 points).
- ECOG PS score within 7 days before randomization: 0-1 points.
- Have not received systematic anti-tumor treatment for hepatocellular carcinoma in the past.
- Expected survival time ≥ 12 weeks.
- The main organ functions meet the following requirements (within 7 days before randomization): (1) Blood routine examination: (excluding hemoglobin, no blood transfusion within 14 days prior to screening, no use of...
- Neutrophil absolute count ≥ 1.5 × 109/L; Platelets ≥ 75 × 10\^9/L; Hemoglobin ≥ 90 g/L.(Leukocyte and thrombocytopenia caused by splenic hyperfunction can be included in the group after partial embolization of the...
What rules you out
- If a subject meets any of the following conditions, they will not be allowed to enter this study:
- Known hepatobiliary carcinoma, sarcoma like hepatocellular carcinoma, combined hepatocellular-cholangiocarcinoma，and fibrous layer cell carcinoma; Within 5 years or simultaneously suffering from other active malignant...
- There are uncontrollable extrahepatic metastases, such as lung and brain metastases (EHS).
- Previously received local treatment, including therapeutic TACE, transarterial embolization (TAE), hepatic artery infusion chemotherapy (HAIC), transarterial radiation embolization (TARE), etc.
- Participants who are preparing to undergo or have previously received organ or allogeneic bone marrow transplantation.
- Participants who are currently accompanied by interstitial pneumonia or interstitial lung disease, or have a history of interstitial pneumonia or interstitial lung disease that requires hormone therapy in the past, or...
- Currently, there is active autoimmune disease or a history of autoimmune disease that may recur (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation...
- Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg) (based on the average BP reading obtained from ≥ 2 measurements), it is...
- Participants with moderate to severe ascites with clinical symptoms who require therapeutic puncture or drainage, or whose Child Pugh score is greater than 7 (excluding those who only show a small amount of ascites on...
- There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: (1) According to the standards of the New York Heart Association (NYHA), level II or above cardiac insufficiency or cardiac...
- History of spontaneous rupture of liver tumors.
- Individuals with a history of hepatic encephalopathy.
- Congenital or acquired immune dysfunction in people (such as HIV infected individuals).
- There have been incidents of thrombosis or embolism occurring within the first 6 months of treatment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction)...
- Participants with a history of gastrointestinal bleeding or a clear tendency towards gastrointestinal bleeding within 6 months prior to the start of the study treatment, such as those at risk of bleeding or severe...
- Within 6 months prior to the start of treatment, there have been abdominal fistulas, gastrointestinal perforation, or abdominal abscesses.
- Severe, unhealed or cracked wounds, as well as active ulcers or untreated fractures.
- Known genetic or acquired bleeding (such as coagulation dysfunction) or thrombotic tendencies, such as in hemophilia participants; Currently or recently (within 10 days prior to the start of research treatment), full...
- Major vascular diseases (such as aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) occur within 6 months prior to the start of the study treatment.
- Severe infection within 4 weeks prior to the start of the study treatment, including but not limited to hospitalization due to complications of infection, bacteremia, or severe pneumonia; Oral or intravenous...
- It is known that the active ingredients and excipients contained in the investigational drugs (Adebelimumab, Apatinib) in this study have hypersensitivity reactions, or have a history of severe allergies to any other...
- Use immunosuppressive agents or systemic hormone therapy within 14 days prior to the start of the study to achieve immunosuppressive effects (dose\>10mg/day prednisone or other therapeutic hormones).
- Received attenuated live vaccine treatment within 28 days prior to the start of the study treatment, or expected to receive such vaccines during the treatment period with Adebrelimab or within 60 days after the last...
- Received other experimental drug treatments within 28 days or 5 half-lives (whichever is longer) prior to the start of the study treatment.
- According to the judgment of the researchers, the people may have other factors that may affect the research results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious illnesses...
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, 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 Jinan, Shandong, 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.