Recurrent Liver Cancer After Liver TransplantationPhase 2NCT05833126
Hepatic Arterial Infusion Chemotherapy in Combination With Atezolizumab and Bevacizumab for Second-line Treatment of Patients With Recurrent Liver Cancer After Liver Transplantation
A Phase 2 study testing Hepatic arterial infusion chemotherapy + Atezolizumab and bevacizumab in people with Recurrent Liver Cancer After Liver Transplantation, run by Shuhong Yi at 1 site in China.
Trial summary
For patients with recurrent liver cancer after liver transplantation, the median survival time is low and the prognosis is often poor. On the one hand, it is necessary to take into account the weakened effect of postoperative anti-rejection drugs with the use of immune checkpoint inhibitors, and on the other hand, the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent Liver Cancer After Liver Transplantation
- What is being tested?
- Hepatic arterial infusion chemotherapy + Atezolizumab and bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2023to 1 Apr 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, ≤75 years old, gender unlimited;
- hepatocellular carcinoma confirmed by pathology after liver transplantation;
- CT and/or MRI confirmed tumor recurrence or metastasis, and the tumor recurrence and metastasis were not suitable for radical treatment such as surgical resection or ablation after multidisciplinary evaluation, and disease progression occurred after one first-line treatment regimen without immunotherapy;
- There is at least one measurable recurrent or metastatic tumor lesion;
- The expected survival time is more than 3 months;
- Child-Pugh grade A and B (≤7 points);
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- Function of other vital organs: absolute neutrophil count ≥1.5×10E9/L; Platelet ≥50×10 e9 / L; Hemoglobin ≥9 g/dL; Serum albumin ≥2.8g/dL; Thyroid stimulating hormone (TSH)≤1 ULN(if TSH is abnormal, both T3 and T4 levels should be checked. If the levels of T3 and T4 were normal, the patients could be enrolled); Bilirubin ≤ 1.5x ULN; ALT and AST≤3 times ULN; Serum creatinine ≤1.5 ULN;
- ECOG scored 0-2 points;
- The patient fully understands and voluntarily signs the informed consent, and is willing and able to comply with the requirements of visit, treatment plan, laboratory examination and other requirements of the study schedule.
Who cannot join
- Positive expression of PD-L1 in immunohistochemical liver biopsy (parenchymal or non-parenchymal cells of liver);
- Allergic to bevacizumab and Atezolizumab;
- ≥ grade II myocardial ischemia or myocardial infarction;
- The hypertensive drugs cannot be controlled to the normal level (systolic blood pressure > 140mmHg, diastolic blood pressure > 90mmHg); Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg <2g/L), a history of gastrointestinal bleeding within 6 months;
- Patients with high risk of bleeding or receiving thrombolytic or anticoagulant treatment;
- Autoimmune diseases include systemic lupus erythematosus, rheumatoid arthritis, psoriasis, etc.;
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- The primary liver disease of liver transplantation was autoimmune hepatitis, primary biliary cirrhosis, or primary sclerosing cholangitis;
- interstitial pneumonia and other lung diseases, poor lung function;
- Participate in clinical trials of other experimental drugs within 4 weeks;
- infections requiring systemic treatment;
- human immunodeficiency virus (HIV) positive infection;
- Other factors that may affect safety or compliance;
- During treatment of acute rejection or within 1 month after treatment;
- Poor compliance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Liver Transplantation, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Jianfeng Zhang, MD, 13935197625, zhangjianfenggzq@163.com
Shuhong Yi, M.D.
About this study
Official title: Hepatic Arterial Infusion Chemotherapy in Combination With Atezolizumab and Bevacizumab for Second-line Treatment of Patients With Recurrent Liver Cancer After Liver Transplantation: an Open-label, Prospective, Single-center, Single-arm Clinical Study Protocol
For patients with recurrent liver cancer after liver transplantation, the median survival time is low and the prognosis is often poor. On the one hand, it is necessary to take into account the weakened effect of postoperative anti-rejection drugs with the use of immune checkpoint inhibitors, and on the other hand, the therapeutic effect of recurrent tumors should be taken into account. Both HAIC (hepatic arterial infusion chemotherapy) and T+A（Bevacizumab+Atezolizumab) have inhibitory effects on tumor, and we consider combining them organically to explore one that not only has a good inhibitory effect on tumor, but also better reduces the risk and degree of rejection. Therefore, in order to determine the feasibility and effectiveness of hepatic arterial infusion chemotherapy combined with Atezolizumab and Bevacizumab in the second-line treatment of patients with recurrent liver cancer after liver transplantation
- Being tested
- Hepatic arterial infusion chemotherapy + Atezolizumab and bevacizumab
- Keywords
- Atezolizumab, Bevacizumab, Hepatic arterial infusion chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic arterial infusion chemotherapy + Atezolizumab and bevacizumabDrug
Drug: Oxaliplatin, calcium folinate, 5-FU, Atezolizumab and bevacizumab Procedure: HAIC
| Study group | Role | What they receive |
|---|---|---|
| Hepatic arterial infusion chemotherapy + Atezolizumab and bevacizumab | Experimental | Hepatic arterial infusion chemotherapy: percutaneous introduction of a standard hepatic arterial catheter through the femoral artery. FOLFOX was sequentially transfused by a fixed catheter. Drugs:FOLFOX regimen: oxaliplatin, calcium folinate, and 5-FU.
Atezolizumab: About 3 to 7 days after HAIC treatment, when liver function is stable (TBILI<2 times the upper limit of normal), Atezolizumab therapy can be started. The dosage was 1200mg and was given intravenously for at least 1 hour, once every 3 weeks. The longest course of treatment is 24 months.
Bevacizumab: About 3 to 7 days after HAIC treatment, when liver function is stable (TBILI<2 times the upper limit of normal), bevacizumab therapy can be started. The dosage was 15mg/kg and was given intravenously for no less than 1 hour, once every 3 weeks. The longest course of treatment is 24 months. Receives: Drug: Hepatic arterial infusion chemotherapy + Atezolizumab and bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute graft rejection rate
defined as the incidence of acute graft rejection after HAIC combined with T+A.
Measured: 3 months
Objective Response Rate
defined as the treatment response assessed by mRECIST after HAIC combined with T+A treatment
Measured: 1 year
Secondary outcomes (5)
Overall Survival
defined as the time from HAIC combined with T+A treatment to patient death from any cause.
Measured: 1 year
Progression-free Survival
defined as the time from the start of HAIC combined with T+A treatment to the onset of tumor Progression or death from any cause.
Measured: 1 year
Time to Progression
defined as the time from the start of HAIC combined with T+A treatment to tumor progression or death from any cause.
Measured: 1 year
Serious Adverse Event
The incidence of serious adverse events caused by HAIC combined with T+A treatment.
Measured: 1 year
Graft Rejection
defined as the incidence of transplant rejection during HAIC combined with T+A treatment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start3 Dec 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Liver Cancer After Liver TransplantationStudies 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shuhong Yi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shuhong Yi, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Shuhong Yi, Study director, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833126
- Sponsor's protocol ID
- [2023]02-116-99
- Status last verified
- Dec 2023
- First submitted
- 29 Mar 2023
- Last updated
- 15 Dec 2023
- Results posted
- 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 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Arterial Infusion Chemotherapy in Combination With Atezolizumab and Bevacizumab for Second-line Treatment of Patients With Recurrent Liver Cancer After Liver Transplantation: an Open-label, Prospective, Single-center, Single-arm Clinical Study Protocol
- ClinicalTrials.gov ID
- NCT05833126
- Acronym / sponsor ID
- [2023]02-116-99
- Keywords
- Atezolizumab, Bevacizumab, Hepatic arterial infusion chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Shuhong YiUniversity, hospital or other
- Study start
- 3 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 27 Apr 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.
For patients with recurrent liver cancer after liver transplantation, the median survival time is low and the prognosis is often poor. On the one hand, it is necessary to take into account the weakened effect of postoperative anti-rejection drugs with the use of immune checkpoint inhibitors, and on the other hand, the therapeutic effect of recurrent tumors should be taken into account. Both HAIC (hepatic arterial infusion chemotherapy) and T+A（Bevacizumab+Atezolizumab) have inhibitory effects on tumor, and we consider combining them organically to explore one that not only has a good inhibitory effect on tumor, but also better reduces the risk and degree of rejection. Therefore, in order to determine the feasibility and effectiveness of hepatic arterial infusion chemotherapy combined with Atezolizumab and Bevacizumab in the second-line treatment of patients with recurrent liver cancer after liver transplantation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatic arterial infusion chemotherapy + Atezolizumab and bevacizumab | Experimental | Drug: Hepatic arterial infusion chemotherapy + Atezolizumab and bevacizumabHepatic arterial infusion chemotherapy: percutaneous introduction of a standard hepatic arterial catheter through the femoral artery. FOLFOX was sequentially transfused by a fixed catheter. Drugs:FOLFOX regimen: oxaliplatin, calcium folinate, and 5-FU. Atezolizumab: About 3 to 7 days after HAIC treatment, when liver function is stable (TBILI<2 times the upper limit of normal), Atezolizumab therapy can be started. The dosage was 1200mg and was given intravenously for at least 1 hour, once every 3 weeks. The longest course of treatment is 24 months. Bevacizumab: About 3 to 7 days after HAIC treatment, when liver function is stable (TBILI<2 times the upper limit of normal), bevacizumab therapy can be started. The dosage was 15mg/kg and was given intravenously for no less than 1 hour, once every 3 weeks. The longest course of treatment is 24 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years old, ≤75 years old, gender unlimited;
- hepatocellular carcinoma confirmed by pathology after liver transplantation;
- CT and/or MRI confirmed tumor recurrence or metastasis, and the tumor recurrence and metastasis were not suitable for radical treatment such as surgical resection or ablation after multidisciplinary evaluation, and disease progression occurred after one first-line treatment regimen without immunotherapy;
- There is at least one measurable recurrent or metastatic tumor lesion;
- The expected survival time is more than 3 months;
Key exclusion criteria (14 listed)
- Positive expression of PD-L1 in immunohistochemical liver biopsy (parenchymal or non-parenchymal cells of liver);
- Allergic to bevacizumab and Atezolizumab;
- ≥ grade II myocardial ischemia or myocardial infarction;
- The hypertensive drugs cannot be controlled to the normal level (systolic blood pressure > 140mmHg, diastolic blood pressure > 90mmHg); Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg <2g/L), a history of gastrointestinal bleeding within 6 months;
- Patients with high risk of bleeding or receiving thrombolytic or anticoagulant treatment;
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 |
|---|---|---|
| Hepatic arterial infusion chemotherapy + Atezolizumab and bevacizumabDrug: Oxaliplatin, calcium folinate, 5-FU, Atezolizumab and bevacizumab Procedure: HAIC | Drug | Hepatic arterial infusion chemotherapy + Atezolizumab and bevacizumab |
Primary outcome
Acute graft rejection rate
Time frame: 3 months
defined as the incidence of acute graft rejection after HAIC combined with T+A.
Objective Response Rate
Time frame: 1 year
defined as the treatment response assessed by mRECIST after HAIC combined with T+A treatment
5 secondary outcomes
Overall Survival
Time frame: 1 year
Progression-free Survival
Time frame: 1 year
Time to Progression
Time frame: 1 year
Serious Adverse Event
Time frame: 1 year
Graft Rejection
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- 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.
Shuhong Yi study director
Third Affiliated Hospital, Sun Yat-Sen University
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 Hepatic arterial infusion chemotherapy + Atezolizumab and bevacizumab in people with Recurrent Liver Cancer After Liver Transplantation, run by Shuhong Yi 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 9 inclusion and 14 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 15 Dec 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?
Contact Hua Li, MD&PhD (13060975202, lihua100@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute graft rejection rate (time frame: 3 months). The study lists 2 primary outcomes in all. 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 15 Dec 2023.