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Efficacy and biomarkers of transarterial chemoembolization in combination with targeted and immunotherapy in HBV-associated hepatocellular carcinoma patients: A Prospective study

Efficacy and biomarkers of transarterial chemoembolization in combination with targeted and immunotherapy in HBV-associated hepatocellular carcinoma patients: A Prospective study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092461
Enrollment
Unknown
Registered
2024-11-18
Start date
2024-11-20
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatocellular carcinoma

Interventions

Efficacy group:NA

Sponsors

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) patients with stage IIb-IIIa hepatocellular carcinoma who met the diagnostic criteria of hepatocellular carcinoma in the "Guidelines for the diagnosis and treatment of primary liver cancer (2024 version)"; (2) excluding other factors, the patients with hbv-related liver cancer were diagnosed (3) did not receive any anti-tumor therapy before; (4) the patients who accepted TACE combined with systemic therapy (anti-PD1/PDL1 mcab combined with bevacizumab) because of the need of their condition; (5) ECOG physical fitness score of 0-1, i.e. full normal or free movement and light physical activity, including general household or office work, but not heavier physical activity; (6) at least one evaluable lesion on imaging (single diameter can be measured accurately, longest diameter >=1cm) ; (7) age >=18 years, gender is not limited; (8) those who understand and voluntarily participate in the study and are able to comply with the program;

Exclusion criteria

Exclusion criteria: (1) severe hepatic dysfunction (Child-Puch C) , including uncorrectable severe jaundice, hepatic encephalopathy, refractory ascites, Coagulopathy, etc. ; (2) renal insufficiency: serum creatinine > 176.8 µmol/L or serum creatinine clearance < 30 mL/min; (3) the number of WBC and platelet in peripheral blood decreased significantly. After active treatment, WBC was still less than 3.0 × 10^9/L and platelet was still less than 50 × 10^9/L (4) the main portal vein was completely embolized by tumor thrombus or thrombus, and the collateral branches of portal vein were not adequately compensated and could not reconnect the portal vein to the liver effectively by portal vein plasty; (5) severe infection that can not be effectively controlled; (6) patients who plan to receive or have received organ transplantation or bone marrow transplantation; (7) history of any of the following systemic diseases: Patients with unstable arrhythmia or unstable angina; Patients who had a heart attack, myocardial infarction, or cerebrovascular accident (NYHA Class II or higher) within 3 months before starting treatment; Patients with a history of Idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, or idiopathic pneumonia; Patients with autoimmune diseases; Patients with other tumors; Patients with a history of mental illness; Patients with known drug dependence; (8) patients with severe iodine contrast allergy, who were allergic to the drugs used in this study (chemotherapy drugs) , and who had a severe allergic/anaphylactic reaction to chimeric or humanized antibodies or fusion proteins; A female patient who is pregnant or lactating or who plans to become pregnant; (10) those who could not return to hospital and follow-up regularly according to the study plan; (11) those who can not comply with the study arrangement and sign the informed consent form; (12) other conditions that the researchers judged unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
test for hepatitis B ;HBV DNA;AFP;abnormal prothrombin;liver imaging examination;PBMC single cell sequencing;

Secondary

MeasureTime frame
complete blood count;blood biochemistry;coagulation function;thyroid function;

Countries

China

Contacts

Public ContactNing Qin

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

qning@vip.sina.com+86 139 7152 1450

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026