Hepatocellular carcinoma
Conditions
Interventions
Sponsors
Mengchao Hepatobiliary Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 years old, male or female; 2. Patients with hepatocellular carcinoma who strictly comply with the clinical diagnostic criteria of the code for the diagnosis and treatment of primary liver cancer (version 2019) or confirmed by histopathology or cytology, and have at least one measurable lesion (according to recist1.1 standard, the measurable lesion's spiral CT scanning length = 10 mm or malignant lymph node's short diameter >= 15 mm, recist1.1 version is shown in Annex 4); 3. Patients with HCC who are not suitable for surgery or local treatment and have not received any systemic therapy for the lesion, who voluntarily choose karelizumab for treatment; or patients with HCC who have progressed / intolerable through first-line systemic therapy; 4. Patients with grade a chlid Pugh score; 5. Patients with CNLC stage IIB - IIIB; 6. Patients with ECoG PS score of 0-1; 7. Patients with an estimated survival time of 12 weeks or more; 8. If the patient has active hepatitis B virus (HBV) infection: HBV DNA must be less than 2000 IU / ml (if the research center has only copy / ml testing unit, it must be less than 12500 IU / ml) Patients with positive hepatitis C virus (HCV) RNA must receive antiviral therapy according to the local standard treatment guidelines and their liver function should be within CTC AE level 1; 9. The patients who voluntarily joined the study had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who have been proved to be allergic to karelizumab injection and its excipients or to other monoclonal antibodies; 2. Pregnant or lactating women; 3. Patients with contraindications of immunotherapy include but are not limited to the following: Patients after transplantation, patients with severe autoimmune diseases, patients with organ failure, patients with grade 4 or above adverse reactions of immunotherapy in the past, patients with uncontrollable infectious diseases, etc; 4. Patients who used other immunotherapy or participated in other immunotherapy related clinical studies within one month before enrollment and whose AE did not return to <= CTC AE 1 degree; 5. Patients considered unsuitable by doctors; 6. Patients with incomplete important imaging examination or test and incomplete adverse reaction record.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective remission rate;Disease control rate;overall survival;Duration of remission;safety; | — |
Countries
China
Contacts
Public ContactYongyi Zeng
Mengchao Hepatobiliary Hospital of Fujian Medical University
Outcome results
None listed