Hepatocellular CarcinomaPhase 2NCT05975463
Hepatic Artery Infusion of Adebrelimab Combined With Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma With Failure of Systemic Therapy Combined With Interventional Therapy
A Phase 2 study testing HAIC, Adebrelimab and Bevacizumab in people with Hepatocellular Carcinoma, run by HuiKai Li at 1 site in China.
Trial summary
The goal of this prospective single arm, Phase II Clinical Study is to explore and evaluate the efficacy and safety of hepatic artery infusion of Adebrelimab combined with Bevacizumab in the treatment of patients with advanced hepatocellular carcinoma who failed in systematic therapy combined with interventional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- HAIC, Adebrelimab and Bevacizumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2023to 31 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Non resectable advanced hepatocellular carcinoma confirmed by pathological and clinical imaging examinations.
- 2. Patients who have previously received systematic treatment combined with failed or intolerable interventional therapy.
- 3. Male or female, aged ≥ 18 years at the time of signing the Informed consent form (ICF).
- 4. The liver should have at least one measurable target lesion (RECIST v1.1). If it is an active lesion after local treatment (radiotherapy, ablation, transcatheter arterial chemoembolization, etc.), local treatment should be completed 4 weeks before the screening period imaging examination.
- 5. The patient's Eastern Oncology Collaborative Group (ECOG) physical condition score is 0 or 1.
- 6. The patient's organ and blood system functions meet the requirements:
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- Hematology function: Absolute neutrophil count (ANC) ≥ 1.5 x 10 ^ 9/L, platelet count ≥ 75 x 10 ^ 9/L
- Adequate renal function: serum creatinine<1.5x ULN or creatinine clearance rate>40 mL/min (Cockcroft Fault formula)
- Liver function: Total bilirubin ≤ 1.5 x ULN, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 5 x ULN
- Coagulation function: Within the normal range of Prothrombin time (PT) .
- 7. Female participants with Fertility need to carry out serum pregnancy test within 72 hours before starting the study drug administration, and the result is negative, and take effective contraceptive measures (such as Intrauterine device, contraceptive pill or pregnancy avoidance condom) during the test period and at least 3 months after the last administration; For male participants whose partners are Fertility women, they should be surgically sterilized or agree to take effective contraceptive measures during the trial period and within 3 months after the last administration.
- 8. The participants have good compliance and cooperate with follow-up.
Who cannot join
- 1. Has a history of allergies to any component of the study drug in the past;
- 2. Known to be allergic to Programmed Death-1/Programmed Death-L1 (PD-1/PD-L1) antibodies or have experienced drug-related Immune related adverse events (irAEs) in the past, in accordance with the "Guidelines Of Chinese Society Of Clinical Oncology [CSCO]Management Of Immune Checkpointinhibitor-Related Toxicity 2019", it meets the indication for permanent discontinuation of medication;
- 3. There are known Contraindication of percutaneous hepatic artery infusion;
- 4. Has received or is currently receiving any of the following treatments in the past:
- The patient underwent major surgical procedures within 14 days prior to entering the study (puncture biopsy is not included)
- Previous or planned immune therapy such as Chimeric antigen receptor T cell immunotherapy (CAR-T) and vaccines
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- 5. Have any active autoimmune disease or history of autoimmune disease, including but not limited to interstitial pneumonia, enteritis, hepatitis, hypophysitis, Vasculitis, nephritis, hyperthyroidism, hypothyroidism (it can be considered to be included after hormone replacement treatment); Patients with psoriasis or childhood asthma/allergy that has completely alleviated and does not need any intervention after adulthood can be considered for inclusion, but patients who need medical intervention with Bronchiectasis cannot be included;
- 6. Poor nutritional status, BMI<18.5 Kg/m2; If symptomatic nutritional support is provided and corrected before enrollment, and evaluated by the main investigator, enrollment can continue to be considered;
- 7. Have a history of immune deficiency, including positive Diagnosis of HIV/AIDS, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or allogeneic bone marrow transplantation;
- 8. There are clinical symptoms or diseases of the heart that cannot be well controlled, including but not limited to: (1) New York Heart Association (NYHA)grade II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias that have not undergone clinical intervention or are still poorly controlled after clinical intervention;
- 9. Serious infection (CTCAE>grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, Bloodstream infections, infection complications, etc. requiring hospitalization; Baseline chest imaging examination indicates the presence of active pulmonary inflammation, symptoms and signs of infection within 14 days prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, excluding prophylactic use of antibiotics;
- 10. Those who have been found to have active pulmonary tuberculosis infection through medical history or CT examination, or have a history of active pulmonary tuberculosis infection within 1 year before enrollment, or have a history of active pulmonary tuberculosis infection more than 1 year before but have not received formal treatment;
- 11. There is active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL) and hepatitis C (hepatitis C antibody is positive, and HCV RNA is higher than the detection limit of the analytical method);
- 12. Other malignant tumors were diagnosed within 5 years before the first use of the study drug, except for malignant tumors with low risk of metastasis or death (5-year survival rate>90%), such as fully treated skin Basal-cell carcinoma or squamous cell skin cancer or cervical Carcinoma in situ, which can be considered to be included in the group;
- 13. Pregnant or lactating women;
- 14. Previous history of hypertensive crisis or hypertensive encephalopathy;
- 15. Use Nonsteroidal anti-inflammatory drug (NSAIDs) for long-term daily treatment;
- 16. Untreated or incompletely treated esophageal and/or gastric varices with high risk of bleeding or bleeding;
- 17. Previous bleeding events caused by esophageal and/or gastric varices within 6 months prior to the start of the study treatment;
- 18. According to the judgment of the investigators, there are other factors that may lead to forced termination of the study, such as suffering from other serious illnesses (including mental illness) requiring concurrent treatment, alcoholism, drug abuse, family or social factors, which may affect the safety or compliance of the participants.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300308
About this study
Official title: Prospective Single Arm, Single Center, Phase II Clinical Study of Hepatic Artery Infusion of Adebrelimab Combined With Bevacizumab Treatment System for Advanced Hepatocellular Carcinoma With Failure of Systemic Therapy Combined With Interventional Therapy
The goal of this prospective single arm, Phase II Clinical Study is to explore and evaluate the efficacy and safety of hepatic artery infusion of Adebrelimab combined with Bevacizumab in the treatment of patients with advanced hepatocellular carcinoma who failed in systematic therapy combined with interventional therapy.
Participants will receive hepatic artery infusion of Adebrelimab 1200mg, d1, q3w, combined with hepatic artery infusion of Bevacizumab 5mg/kg, d1, q3w, HAIC treatment for 3-4 times.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- HAIC, Adebrelimab, Bevacizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAICProcedure or surgery
hepatic artery infusion for 3-4 times.
AdebrelimabDrug
hepatic artery infusion of Adebrelimab 1200mg, d1, q3w，for 3-4 times.
BevacizumabDrug
hepatic artery infusion of Bevacizumab 5mg/kg, d1, q3w, for 3-4 times.
| Study group | Role | What they receive |
|---|---|---|
| HAIC+Adebrelimab+Bevacizumab | Experimental | hepatic artery infusion of Adebrelimab 1200mg, d1, q3w, combined with hepatic artery infusion of Bevacizumab 5mg/kg, d1, q3w, HAIC treatment for 3-4 times. Receives: Procedure: HAIC; Drug: Adebrelimab; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective response rate
Measured: Up to one year
Secondary outcomes (3)
Progression-free survival (PFS)
Progression-free survival：The time from the start of treatment to the progression of the disease or death from any cause
Measured: Up to two years
Overall Survival (OS)
Overall Survival：The survival time from enrollment to death from any cause.
Measured: Up to two years
Disease Control Rate (DCR)
Disease Control Rate: Ratio of complete response (CR)+partial response (PR)+stable disease (SD)
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start15 Sep 2023 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HuiKai Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, HuiKai Li, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975463
- Sponsor's protocol ID
- SHR1316-HCC-TJ-001
- Status last verified
- Aug 2023
- First submitted
- 27 Jul 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single Arm, Single Center, Phase II Clinical Study of Hepatic Artery Infusion of Adebrelimab Combined With Bevacizumab Treatment System for Advanced Hepatocellular Carcinoma With Failure of Systemic Therapy Combined With Interventional Therapy
- ClinicalTrials.gov ID
- NCT05975463
- Acronym / sponsor ID
- SHR1316-HCC-TJ-001
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- HuiKai LiUniversity, hospital or other
- Study start
- 15 Sep 2023 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 4 Aug 2023 (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.
The goal of this prospective single arm, Phase II Clinical Study is to explore and evaluate the efficacy and safety of hepatic artery infusion of Adebrelimab combined with Bevacizumab in the treatment of patients with advanced hepatocellular carcinoma who failed in systematic therapy combined with interventional therapy.
Participants will receive hepatic artery infusion of Adebrelimab 1200mg, d1, q3w, combined with hepatic artery infusion of Bevacizumab 5mg/kg, d1, q3w, HAIC treatment for 3-4 times.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAIC+Adebrelimab+Bevacizumab | Experimental | Procedure: HAIC, Drug: Adebrelimab, Drug: Bevacizumabhepatic artery infusion of Adebrelimab 1200mg, d1, q3w, combined with hepatic artery infusion of Bevacizumab 5mg/kg, d1, q3w, HAIC treatment for 3-4 times. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Non resectable advanced hepatocellular carcinoma confirmed by pathological and clinical imaging examinations.
- 2. Patients who have previously received systematic treatment combined with failed or intolerable interventional therapy.
- 3. Male or female, aged ≥ 18 years at the time of signing the Informed consent form (ICF).
- 4. The liver should have at least one measurable target lesion (RECIST v1.1). If it is an active lesion after local treatment (radiotherapy, ablation, transcatheter arterial chemoembolization, etc.), local treatment should be completed 4 weeks before the screening period imaging examination.
- 5. The patient's Eastern Oncology Collaborative Group (ECOG) physical condition score is 0 or 1.
Key exclusion criteria (20 listed)
- 1. Has a history of allergies to any component of the study drug in the past;
- 2. Known to be allergic to Programmed Death-1/Programmed Death-L1 (PD-1/PD-L1) antibodies or have experienced drug-related Immune related adverse events (irAEs) in the past, in accordance with the "Guidelines Of Chinese Society Of Clinical Oncology [CSCO]Management Of Immune Checkpointinhibitor-Related Toxicity 2019", it meets the indication for permanent discontinuation of medication;
- 3. There are known Contraindication of percutaneous hepatic artery infusion;
- 4. Has received or is currently receiving any of the following treatments in the past:
- 5. Have any active autoimmune disease or history of autoimmune disease, including but not limited to interstitial pneumonia, enteritis, hepatitis, hypophysitis, Vasculitis, nephritis, hyperthyroidism, hypothyroidism (it can be considered to be included after hormone replacement treatment); Patients with psoriasis or childhood asthma/allergy that has completely alleviated and does not need any intervention after adulthood can be considered for inclusion, but patients who need medical intervention with Bronchiectasis cannot be included;
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 |
|---|---|---|
| HAIChepatic artery infusion for 3-4 times. | Procedure or surgery | HAIC+Adebrelimab+Bevacizumab |
| Adebrelimabhepatic artery infusion of Adebrelimab 1200mg, d1, q3w，for 3-4 times. | Drug | HAIC+Adebrelimab+Bevacizumab |
| Bevacizumabhepatic artery infusion of Bevacizumab 5mg/kg, d1, q3w, for 3-4 times. | Drug | HAIC+Adebrelimab+Bevacizumab |
Primary outcome
Objective response rate (ORR)
Time frame: Up to one year
Objective response rate
3 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to two years
Overall Survival (OS)
Time frame: Up to two years
Disease Control Rate (DCR)
Time frame: Up to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 HAIC, Adebrelimab and Bevacizumab in people with Hepatocellular Carcinoma, run by HuiKai Li 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 12 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 1 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to one year). 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 1 Sep 2023.