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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