Advanced Hepatocellular CarcinomaPhase 2NCT06301399
Rituximab Combined With Prior Therapy in Advanced Hepatocellular Carcinoma: Efficacy & Safety Study
A Phase 2 study testing Rituximab+PD-1 or PD-L1 inhibitors+targeted therapy in people with Advanced Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Evaluation of the efficacy and safety of adding rituximab after failure of target immunotherapy in the Posterior treatment of advanced hepatocellular carcinoma Read more about this study
- Who is it for?
- Ages 17 to 79 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- Rituximab+PD-1 or PD-L1 inhibitors+targeted therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 79 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Huikai Li, +862223340123 ext. 3091, lihuikai@tjmuch.com
About this 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
Evaluation of the efficacy and safety of adding rituximab after failure of target immunotherapy in the Posterior treatment of advanced hepatocellular carcinoma
Read the detailed description
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
- Being tested
- Rituximab+PD-1 or PD-L1 inhibitors+targeted therapy
- Keywords
- rituximab, Advanced Hepatocellular Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab+PD-1 or PD-L1 inhibitors+targeted therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Rituximab+PD-1 or PD-L1 inhibitors+targeted therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
mRESIST
Measured: from the date of enrollment to death from any cause. (assessed up to 12 months）
Secondary outcomes (4)
PFS
mRESIST
Measured: from the date of enrollment to death from any cause. (assessed up to 12 months）
OS
mRESIST
Measured: from the date of enrollment to death from any cause. (assessed up to 12 months）
DoR
mRESIST
Measured: from the date of enrollment to death from any cause. (assessed up to 12 months）
DCR
mRESIST
Measured: from the date of enrollment to death from any cause. (assessed up to 12 months）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start20 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301399
- Sponsor's protocol ID
- Rituximab01
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06301399
- Acronym / sponsor ID
- Rituximab01
- Conditions
- Advanced Hepatocellular Carcinoma
- Keywords
- rituximab, Advanced Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab+PD-1 or PD-L1 inhibitors+targeted therapy | Experimental | Drug: Rituximab+PD-1 or PD-L1 inhibitors+targeted therapyRituximab: 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. |
Who may qualify
- Ages
- 17 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rituximab+PD-1 or PD-L1 inhibitors+targeted therapyRituximab: 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. | Drug | Rituximab+PD-1 or PD-L1 inhibitors+targeted therapy |
Primary outcome
ORR
Time frame: from the date of enrollment to death from any cause. (assessed up to 12 months）
mRESIST
4 secondary outcomes
PFS
Time frame: from the date of enrollment to death from any cause. (assessed up to 12 months）
OS
Time frame: from the date of enrollment to death from any cause. (assessed up to 12 months）
DoR
Time frame: from the date of enrollment to death from any cause. (assessed up to 12 months）
DCR
Time frame: from the date of enrollment to death from any cause. (assessed up to 12 months）
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab+PD-1 or PD-L1 inhibitors+targeted therapy in people with Advanced Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: from the date of enrollment to death from any cause. (assessed up to 12 months）). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.