HCC - Hepatocellular CarcinomaPhase 2NCT06375317
HAIC Combined With PD-L1 Plus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma After Immunotherapy Failure
A Phase 2 study testing PD-L1 inhibitor: Adebrelimab Injection；Regorafenib Tablets in people with HCC - Hepatocellular Carcinoma, run by Yehua Shen.
Trial summary
For patients with advanced liver cancer who have progressed after first-line targeted and immunotherapy , there is currently no standard treatment regimen for second-line therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma
- What is being tested?
- PD-L1 inhibitor: Adebrelimab Injection；Regorafenib Tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2024to 30 Oct 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
- Advanced HCC confirmed by imaging or histopathological examination based on biopsy specimens and/or surgical pathology;
- Patients who have failed ≥1 line of PD-1/PD-L1 immune checkpoint inhibitor therapy;
- Imaging diagnosis with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST1.1);
- Expected survival period ≥3 months;
- ECOG performance status of 0-1;
- Child-Pugh score of grade A (i.e., a score of 5 to 6);
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- Adequate organ and bone marrow function;
- Male participants and women of childbearing potential must use contraception from the start of the first dose to 3 months after the last dose;
- Expected good compliance and ability to comply with the study requirements.
Who cannot join
- Previous history of immunotherapy with any of the following:
- Any grade 3 or higher immune-related adverse events (irAEs);
- Any unresolved grade 2 irAEs;
- Any toxicity resulting in permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy;
- Patients assessed as having progressed within ≤3 months during prior immunotherapy.
- Previous treatment with Regorafenib;
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- Known allergy to the study drug or any of its excipients;
- Received any of the following treatments or medications prior to the first study treatment:
- Major surgery within 28 days prior to treatment initiation (diagnostic tissue biopsy is allowed).
- Use of immunosuppressive medications within 7 days prior to treatment initiation, excluding nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e., not exceeding 10 mg/day of prednisone or its equivalent).
- Receipt of immunomodulatory drugs (such as thymosin, interferon, interleukins) within 3 weeks prior to treatment initiation.
- Receipt of attenuated live vaccines within 28 days prior to treatment initiation.
- Receipt of other systemic anticancer therapy within 28 days prior to treatment initiation.
- Known uncontrollable or symptomatic active central nervous system (CNS) metastases;
- Diagnosis of other active malignancies within 2 years prior to study entry, except for locally treated and cured basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid cancer.
- Presence of any active autoimmune disease or history of autoimmune disease with anticipated recurrence;
- Human immunodeficiency virus (HIV) infection or known AIDS, untreated active hepatitis, HBV-DNA >2000 IU/ml with abnormal liver function; hepatitis C or combined HBV and HCV co-infection;
- Within 6 months prior to study entry, experienced:
- Myocardial infarction, severe/unstable angina, NYHA class 2 or higher heart failure, clinically significant ventricular or supraventricular arrhythmias requiring clinical intervention; poorly controlled hypertension;
- History of gastrointestinal bleeding or tendency to gastrointestinal bleeding within the past 6 months;
- Urine protein ≥++ or 24-hour urine protein >1.0g;
- Inability to swallow study drugs, presence of chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis), and factors affecting drug intake and absorption such as intestinal obstruction.
- Pregnant or lactating women, and women of childbearing potential unwilling to adopt effective contraceptive measures;
- Other patients deemed unsuitable for participation in this study by the investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single-center, Single-arm, Exploratory Clinical Study of Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With PD-L1 Plus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma After Immunotherapy Failure.
For patients with advanced liver cancer who have progressed after first-line targeted and immunotherapy , there is currently no standard treatment regimen for second-line therapy. this study aims to explore the efficacy and safety of HAIC combined with PD-L1 and Regorafenib in patients with advanced liver cancer who have failed immunotherapy, not only providing new treatment options for second-line therapy of liver cancer, but also laying the foundation for research on the combination of HAIC and PD-L1 inhibitors plus Regorafenib, which has significant scientific research significance and clinical value.
Read the detailed description
This is A Single-center, Single-arm, Exploratory Clinical Study of Hepatic Arterial Infusion Chemotherapy (HAIC) Combined with PD-L1 Plus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma After Immunotherapy Failure.
In clinical practice, second-line liver cancer treatment still mainly relies on single-agent therapy, which may not provide additional clinical benefits for patients. On one hand, a real-world multicenter study published by ESMO in 2023 showed that the combination of ICIs and TKIs may still have potential efficacy in patients who progress after first-line targeted therapy for advanced liver cancer. Secondly, the combination of targeted therapy and local hepatic arterial infusion chemotherapy (HAIC) may provide a new opportunity for patients with advanced liver cancer who progress after targeted therapy. On the other hand, unlike PD-1 inhibitors, PD-L1 inhibitors can block the binding ability of PD-L1 with B7.1 on the surface of T cells, which is advantageous for comprehensive T cell activation. At the same time, PD-L1 monoclonal antibody only blocks the binding of PD-L1 with PD-1, preserving the function of PD-L2 and avoiding side effects such as interstitial lung disease (ILD), thus having better safety. Therefore, this study aims to explore the efficacy and safety of HAIC combined with PD-L1 and Regorafenib in patients with advanced liver cancer who have failed immunotherapy.
- Conditions
- HCC - Hepatocellular Carcinoma
- Being tested
- PD-L1 inhibitor: Adebrelimab Injection；Regorafenib Tablets
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-L1 inhibitor: Adebrelimab Injection；Regorafenib TabletsDrug
PD-L1 injection: 20 mg/kg, administered every 3 weeks (Q3W).
Regorafenib: 80 mg, orally, once daily (qd), continuously for 14 days per cycle, followed by a 7-day rest period, administered every 3 weeks (Q3W).
FOLFOX regimen: Oxaliplatin 85 mg/m2, Calcium folinate 400 mg/m2, Fluorouracil 400 mg/m2 as an IV bolus, followed by Fluorouracil 1200 mg/m2 infusion over 23 hours, administered every 3 weeks (Q3W) for a total of 6 cycles.
The above doses are recommended doses.
| Study group | Role | What they receive |
|---|---|---|
| HAIC Combined with PD-L1 Plus Regorafenib | Experimental | Not described Receives: Drug: PD-L1 inhibitor: Adebrelimab Injection；Regorafenib Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
Measured: approximately 1years
Secondary outcomes (3)
Disease Control Rate (DCR)
The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable
Measured: Up to approximately 1 years
Progression-Free Survival (PFS)
PFS is defined as time from the start of treatment to progression of disease or death
Measured: approximately 2 years
Overall Survival (OS)
From date of include in this research until the date of death from any cause, whichever came first
Measured: approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start30 Apr 2024 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCC - 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yehua Shen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yehua Shen, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375317
- Sponsor's protocol ID
- HCC-HAIC-001
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-arm, Exploratory Clinical Study of Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With PD-L1 Plus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma After Immunotherapy Failure.
- ClinicalTrials.gov ID
- NCT06375317
- Acronym / sponsor ID
- HCC-HAIC-001
- Conditions
- HCC - Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Yehua ShenUniversity, hospital or other
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 19 Apr 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.
For patients with advanced liver cancer who have progressed after first-line targeted and immunotherapy , there is currently no standard treatment regimen for second-line therapy. this study aims to explore the efficacy and safety of HAIC combined with PD-L1 and Regorafenib in patients with advanced liver cancer who have failed immunotherapy, not only providing new treatment options for second-line therapy of liver cancer, but also laying the foundation for research on the combination of HAIC and PD-L1 inhibitors plus Regorafenib, which has significant scientific research significance and clinical value.
Detailed description
This is A Single-center, Single-arm, Exploratory Clinical Study of Hepatic Arterial Infusion Chemotherapy (HAIC) Combined with PD-L1 Plus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma After Immunotherapy Failure.
In clinical practice, second-line liver cancer treatment still mainly relies on single-agent therapy, which may not provide additional clinical benefits for patients. On one hand, a real-world multicenter study published by ESMO in 2023 showed that the combination of ICIs and TKIs may still have potential efficacy in patients who progress after first-line targeted therapy for advanced liver cancer. Secondly, the combination of targeted therapy and local hepatic arterial infusion chemotherapy (HAIC) may provide a new opportunity for patients with advanced liver cancer who progress after targeted therapy. On the other hand, unlike PD-1 inhibitors, PD-L1 inhibitors can block the binding ability of PD-L1 with B7.1 on the surface of T cells, which is advantageous for comprehensive T cell activation. At the same time, PD-L1 monoclonal antibody only blocks the binding of PD-L1 with PD-1, preserving the function of PD-L2 and avoiding side effects such as interstitial lung disease (ILD), thus having better safety. Therefore, this study aims to explore the efficacy and safety of HAIC combined with PD-L1 and Regorafenib in patients with advanced liver cancer who have failed immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAIC Combined with PD-L1 Plus Regorafenib | Experimental | Drug: PD-L1 inhibitor: Adebrelimab Injection；Regorafenib Tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Advanced HCC confirmed by imaging or histopathological examination based on biopsy specimens and/or surgical pathology;
- Patients who have failed ≥1 line of PD-1/PD-L1 immune checkpoint inhibitor therapy;
- Imaging diagnosis with at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST1.1);
- Expected survival period ≥3 months;
- ECOG performance status of 0-1;
Key exclusion criteria (24 listed)
- Previous history of immunotherapy with any of the following:
- Previous treatment with Regorafenib;
- Known allergy to the study drug or any of its excipients;
- Received any of the following treatments or medications prior to the first study treatment:
- Known uncontrollable or symptomatic active central nervous system (CNS) metastases;
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 |
|---|---|---|
| PD-L1 inhibitor: Adebrelimab Injection；Regorafenib TabletsPD-L1 injection: 20 mg/kg, administered every 3 weeks (Q3W). Regorafenib: 80 mg, orally, once daily (qd), continuously for 14 days per cycle, followed by a 7-day rest period, administered every 3 weeks (Q3W). FOLFOX regimen: Oxaliplatin 85 mg/m2, Calcium folinate 400 mg/m2, Fluorouracil 400 mg/m2 as an IV bolus, followed by Fluorouracil 1200 mg/m2 infusion over 23 hours, administered every 3 weeks (Q3W) for a total of 6 cycles. The above doses are recommended doses. | Drug | HAIC Combined with PD-L1 Plus Regorafenib |
Primary outcome
Objective Response Rate
Time frame: approximately 1years
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
3 secondary outcomes
Disease Control Rate (DCR)
Time frame: Up to approximately 1 years
Progression-Free Survival (PFS)
Time frame: approximately 2 years
Overall Survival (OS)
Time frame: approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD-L1 inhibitor: Adebrelimab Injection；Regorafenib Tablets in people with HCC - Hepatocellular Carcinoma, run by Yehua Shen.
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 9 inclusion and 24 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 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Shen ye Hua, Ph.D (02164175590, syh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: approximately 1years). 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 19 Apr 2024.