Overview

Evaluation of the efficacy and safety of adding rituximab after failure of target immunotherapy in the Posterior treatment of advanced hepatocellular carcinoma

Eligibility

Inclusion Criteria:

• 1)written informed consent signed prior to enrolment.

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2) Age 17-79 years old (including boundary), male or female;

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       3) Subjects with histologically or cytologically confirmed advanced hepatocellular
          carcinoma (HCC), or clinical diagnosis that meets the American Association of
          Liver Diseases (AASLD) diagnostic criteria for hepatocellular carcinoma

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       4) Previous progression or intolerance after failure to target, immunization, or
          conventional therapy (including TKI, ICI, chemotherapy, VEGF monoclonal
          antibody, or ICI combined with TKI/VEGF monoclonal antibody/chemotherapy)

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       5) 2 weeks after the end of previous systemic therapy ≥ the first dose of this
          study, and the treatment-related AEs recovered to NCI-CTCAE ≤ Grade 1 (except
          for alopecia)

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       6) Child-Pugh liver function rating within 7 days prior to the first dose of the
          study drug: A grade and good B grade (≤ 7 points)

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7) Phase B or C as assessed by BCLC or Phase III as assessed by CNLC

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       8) At least one measurable target lesion as assessed by the investigator according
          to the requirements of mRECIST v1.1 within 4 weeks prior to the first dose

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       9) Have adequate organ function (without receiving blood transfusion,
          erythropoietin, granulocyte colony-stimulating factor, albumin, or other
          medical support within 14 days prior to initiation of study drug therapy)

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      10) If the patient has HBsAg(+) or HBcAb(+), HBV-DNA must be < 2500 copies/mL or <
          500 IU/mL or < upper limit of normal (ULN) to be enrolled, and those with
          elevated HBV-DNA must agree to receive nucleoside anti-hepatitis B virus
          therapy. Subjects who are negative for HCV antibody (-) or HCV-RNA are allowed
          to enroll, if HCV-RNA is positive, they need to agree to receive local standard
          standard antiviral therapy, and subjects must have ALT, AST, ≤ 3×ULN to enroll,
          and subjects with hepatitis B and C co-infection need to be excluded (HBV-DNA
          and HCV-RNA are positive)

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      11) Patients with cured hepatitis C are acceptable, and the lower limit of
          detection of HCV RNA < test center before starting study drug treatment

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12) ECOG PS score: 0-1

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13) Expected survival ≥ 12 weeks

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      14) Male or female of childbearing potential who are willing to use contraception
          in the trial, and females of childbearing potential must have a pregnancy test
          within 7 days prior to the first dose with a negative result

• 15)CD20 positive and CD20 scattered (non aggregated) distribution in tumors

Exclusion Criteria:

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1. Known hepatocholangiocarcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma

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       2) History of hepatic encephalopathy within 6 months prior to the first dose of
          this study

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       3) Portal hypertension with endoscopic red signs, or those who are considered by
          the investigator to have a high risk of bleeding or who have had esophageal or
          gastric variceal bleeding within 6 months before the first dose

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       4) Symptomatic brain or meningeal metastases (unless the patient has been >treated
          for 3 months, there is no evidence of progression in imaging results within 4
          weeks before the first dose, and tumor-related clinical symptoms are stable)

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       5) The patient has human immunodeficiency virus (HIV) or active tuberculosis, or
          other uncontrolled active infection

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       6) Those who have undergone major surgery within 4 weeks before enrollment, and
          those who have had bone marrow biopsy, open biopsy, and intracranial biopsy
          within 7 days before screening

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       7) Those who have other malignant tumors in the past 5 years and have not been
          effectively controlled, except for carcinoma in situ of the cervix, squamous
          cell carcinoma of the skin or localized basal cell skin cancer

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       8) Known history of severe allergy to any monoclonal antibody or study drug
          excipient

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9) Pregnant or lactating women

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      10) Other reasons judged by the investigator to be unsuitable for participating in
          this study