Clinical trial NCT06301399: Rituximab Combined With Prior Therapy in Advanced Hepatocellular Carcinoma: Efficacy & Safety Study
Official title: A Study on the Efficacy and Safety of Rituximab When Combined With Prior Targeted Therapy and Checkpoint Immunotherapy as Second-line or Later Therapy in Patients With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Advanced Hepatocellular Carcinoma
Keywords: rituximab
Advanced Hepatocellular Carcinoma
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 20
Sex: ALL
Minimum age (years): 17
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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

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

Primary outcomes:
measure: ORR
timeFrame: from the date of enrollment to death from any cause. (assessed up to 12 months）
Secondary outcomes:
measure: PFS
timeFrame: from the date of enrollment to death from any cause. (assessed up to 12 months）
measure: OS
timeFrame: from the date of enrollment to death from any cause. (assessed up to 12 months）
measure: DoR
timeFrame: from the date of enrollment to death from any cause. (assessed up to 12 months）
measure: DCR
timeFrame: from the date of enrollment to death from any cause. (assessed up to 12 months）
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
Study officials:
References: