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Trial Title: Rituximab Combined With Prior Therapy in Advanced Hepatocellular Carcinoma: Efficacy & Safety Study

NCT ID: NCT06301399

Condition: Advanced Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Rituximab
Immune Checkpoint Inhibitors

Conditions: Keywords:
rituximab
Advanced Hepatocellular Carcinoma

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Rituximab+PD-1 or PD-L1 inhibitors+targeted therapy
Description: Rituximab: Dissolve 375mg/m2 in 0.9% sodium chloride injection, dilute to a concentration of 1 mg/mL of rituximab, intravenous infusion every 3 weeks until tumor progression or intolerable toxic reactions occur. The recommended initial infusion rate is 50mg/h; After the initial 60 minutes, an increase of 50mg/h can be made every 30 minutes until the maximum speed is 400mg/h. The starting rate of rituximab infusion in the future can be 100mg/h, increasing by 100mg/h every 30 minutes until the maximum rate is 400mg/h.
Arm group label: Rituximab+PD-1 or PD-L1 inhibitors+targeted therapy

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

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

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 1)written informed consent signed prior to enrolment. - 2) Age 17-79 years old (including boundary), male or female; - 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 - 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) - 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) - 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) - 7) Phase B or C as assessed by BCLC or Phase III as assessed by CNLC - 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 - 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) - 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) - 11) Patients with cured hepatitis C are acceptable, and the lower limit of detection of HCV RNA < test center before starting study drug treatment - 12) ECOG PS score: 0-1 - 13) Expected survival ≥ 12 weeks - 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 Exclusion Criteria: - 1) Known hepatocholangiocarcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma - 2) History of hepatic encephalopathy within 6 months prior to the first dose of this study - 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 - 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) - 5) The patient has human immunodeficiency virus (HIV) or active tuberculosis, or other uncontrolled active infection - 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 - 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 - 8) Known history of severe allergy to any monoclonal antibody or study drug excipient - 9) Pregnant or lactating women - 10) Other reasons judged by the investigator to be unsuitable for participating in this study

Gender: All

Minimum age: 17 Years

Maximum age: 79 Years

Healthy volunteers: No

Locations:

Facility:
Name: Tianjin Medical University Cancer Institute & Hospital

Address:
City: Tianjin
Zip: 300060
Country: China

Start date: March 20, 2024

Completion date: December 31, 2026

Lead sponsor:
Agency: Tianjin Medical University Cancer Institute and Hospital
Agency class: Other

Source: Tianjin Medical University Cancer Institute and Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06301399

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