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

NCT06301399 | Recruiting Phase 2

• 1 other identifier: Rituximab01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Hepatocellular Carcinoma

Keywords

rituximab; Advanced Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• ORR

  mRESIST

  from the date of enrollment to death from any cause. (assessed up to 12 months）

Secondary Outcomes (4)

• PFS

  from the date of enrollment to death from any cause. (assessed up to 12 months）

• OS

  from the date of enrollment to death from any cause. (assessed up to 12 months）

• DoR

  from the date of enrollment to death from any cause. (assessed up to 12 months）

• DCR

  from the date of enrollment to death from any cause. (assessed up to 12 months）

Study Arms (1)

Rituximab+PD-1 or PD-L1 inhibitors+targeted therapy

EXPERIMENTAL

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. PD-1 (or PD-L1) inhibitors and targeted drugs: Select first-line PD-1 (or PD-L1) inhibitors and VEGFR targeted drugs according to clinical routine treatment, and administer according to the original first-line combination therapy dosage until progression or intolerable toxic reactions occur.

Drug: Rituximab+PD-1 or PD-L1 inhibitors+targeted therapy

Interventions

Rituximab+PD-1 or PD-L1 inhibitors+targeted therapy DRUG

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.

Rituximab+PD-1 or PD-L1 inhibitors+targeted therapy

Eligibility Criteria

• Age: 17 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• )written informed consent signed prior to enrolment.
• \) Age 17-79 years old (including boundary), male or female;
• \) 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
• \) 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)
• \) 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)
• \) 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)
• \) Phase B or C as assessed by BCLC or Phase III as assessed by CNLC
• \) 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
• \) 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)
• \) 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)
• \) Patients with cured hepatitis C are acceptable, and the lower limit of detection of HCV RNA \< test center before starting study drug treatment
• \) ECOG PS score: 0-1
• \) Expected survival ≥ 12 weeks
• \) 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
• )CD20 positive and CD20 scattered (non aggregated) distribution in tumors

You may not qualify if:

• \) Known hepatocholangiocarcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma
• \) History of hepatic encephalopathy within 6 months prior to the first dose of this study
• \) 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
• \) 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)
• \) The patient has human immunodeficiency virus (HIV) or active tuberculosis, or other uncontrolled active infection
• \) 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
• \) 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
• \) Known history of severe allergy to any monoclonal antibody or study drug excipient
• \) Pregnant or lactating women
• \) Other reasons judged by the investigator to be unsuitable for participating in this study

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 8, 2024
• Study Start: March 20, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-02

Locations

CN (1)