Immune Checkpoint Inhibitor Monotherapy or Combined With Molecular Targeting Drugs / Locoregional Therapy for Hepatocellular CarcinomaNCT05609695
Immune Checkpoint Inhibitor Monotherapy or Combined With Molecular Targeted Drugs / Locoregional Therapy in the Treatment of Hepatocellular Carcinoma
An observational study of Immune Checkpoint Inhibitor Monotherapy or Combined With Molecular Targeting Drugs / Locoregional Therapy for Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
Non-intervention observation to evaluate the safety and efficacy of immune checkpoint inhibitors alone or combined with molecular targeted drugs / local interventional therapy in patients with advanced liver cancer, and to provide the best choice for the treatment of patients with advanced liver cancer in different… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Immune Checkpoint Inhibitor Monotherapy or Combined With Molecular Targeting Drugs / Locoregional Therapy for Hepatocellular Carcinoma
- What is being tested?
- Immune checkpoint inhibitor
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Sep 2025
- Phase
- Observational
- 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
Study population: The patients aged from 18 to 75 years old were diagnosed as hepatocellular carcinoma by pathological diagnosis and were in stage C of BCLC.
Who may be able to join
- Written informed consent must be obtained prior to any screening procedures.
- Cytohistological confirmation is required for diagnosis of HCC.
- Patients with advanced (unresectable and/or metastatic, stage C based on Barcelona-Clinic Liver Cancer [BCLC] staging classification) hepatocellular carcinoma which would not be suitable for treatment with loco-regional therapies or have progressed following locoregional therapy such as surgical resection, percutaneous hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy.
- At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
- Current cirrhotic status of Child-Pugh class A-B, with no encephalopathy. Ascites controlled by diuretics is permitted in this study.
- Availability of a representative tumor tissue specimen (archival tumor tissue is allowed) at pre-screening.
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- astern Cooperative Oncology Group Scale for Assessment of Patient Performance Status ≤ 2.
- Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial.
- Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to procedure:
- Hemoglobin > 100g/L Absolute neutrophil count >3.0 ×109/L Neutrophil count > 1.5 ×109/L Platelet count ≥ 50.0 ×109/L Total bilirubin < 51 μmol/L Alanine transaminase (ALT) and aminotransferase (AST) < 5 x upper limit of normal Albumin > 28 g/L Prothrombin time (PT)-international normalized ratio (INR) < 2.3, or PT < 6 seconds above control Serum creatinine < 110 μmol/L
- Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
Who cannot join
- Received any prior systemic chemotherapy or molecular-targeted therapy for HCC such as sorafenib, lenvatinib.
- Previous local therapy completed less than 4 weeks prior to the dosing and, if present any related acute toxicity > grade 1.
- Any contraindications for Immune checkpoint inhibitor procedure
- Renal failure / insufficiency requiring hemo-or peritoneal dialysis.
- Known severe atheromatosis.
- Known uncontrolled blood hypertension (> 160/100 mm/Hg).
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- Patients with any other malignancies within the last 3 years before study start.
- History of HCC tumor rupture.
- Patients with severe encephalopathy. Patients with known active bleeding (e.g. from GI ulcers, esophageal varices) within 2 months prior to baseline/screening visit or with history or evidence of inherited bleeding diathesis or coagulopathy.
- History of cardiac disease.
- Any other condition that would, in the Investigator's judgment, contraindicate patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable or unwilling to swallow medication, social/ psychological issues, etc.
- Patients who have received any other investigational agents within a period of time that is less than the cycle length used for that treatment or equal to 4 weeks (whichever is shorter) prior to starting study drug and recovered from any side effects to grade 1 or less.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Minimally Invasive and Interventional Radiology, Liver Cancer Study and Service Group, Sun Yat-sen University Cancer Center,
Guangzhou, Guangdong, 500060
About this study
Non-intervention observation to evaluate the safety and efficacy of immune checkpoint inhibitors alone or combined with molecular targeted drugs / local interventional therapy in patients with advanced liver cancer, and to provide the best choice for the treatment of patients with advanced liver cancer in different stages.
- Being tested
- Immune checkpoint inhibitor
- Keywords
- Immune checkpoint inhibitor, locoregional therapy, combination therapy, hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune checkpoint inhibitorDrug
After signing the written informed consent form, patients begin to receive single or combined therapy with immune checkpoint inhibitor. The use of immune checkpoint inhibitors takes 3 weeks as a cycle, and the treatment dose for each cycle is carried out in accordance with the latest international authoritative guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Immunotherapy group | Treatment based on immunotherapy. Receives: Drug: Immune checkpoint inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Absence of death of any cause
Measured: 3-years Followed up
Secondary outcomes (2)
Tumor Response
Tumor response to immune checkpoint inhibitor according to RECIST 1.1
Measured: 3-years Followed up
Progress Free Survival
Absence of disease progression other than death
Measured: 3-years Followed up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Mar 2023 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Immune Checkpoint Inhibitor Monotherapy or Combined With Molecular Targeting Drugs / Locoregional Therapy for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Zhao, Sun Yat-sen University
- Investigators
- Ming Zhao, M.D. & Ph.D., Principal investigator, Department of Minimally Invasive and Interventional Radiology, Liver Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609695
- Sponsor's protocol ID
- B2022-341-01
- Status last verified
- Jan 2023
- First submitted
- 3 Nov 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lyu N, Wang X, Li JB, Lai JF, Chen QF, Li SL, Deng HJ, He M, Mu LW, Zhao M. Arterial Chemotherapy of Oxaliplatin Plus Fluorouracil Versus Sorafenib in Advanced Hepatocellular Carcinoma: A Biomolecular Exploratory, Randomized, Phase III Trial (FOHAIC-1). J Clin Oncol. 2022 Feb 10;40(5):468-480. doi: 10.1200/JCO.21.01963. Epub 2021 Dec 14.
PubMed 34905388Lyu N, Kong Y, Mu L, Lin Y, Li J, Liu Y, Zhang Z, Zheng L, Deng H, Li S, Xie Q, Guo R, Shi M, Xu L, Cai X, Wu P, Zhao M. Hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin vs. sorafenib for advanced hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):60-69. doi: 10.1016/j.jhep.2018.02.008. Epub 2018 Feb 20.
PubMed 29471013
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Checkpoint Inhibitor Monotherapy or Combined With Molecular Targeted Drugs / Locoregional Therapy in the Treatment of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05609695
- Acronym / sponsor ID
- B2022-341-01
- Keywords
- Immune checkpoint inhibitor, locoregional therapy, combination therapy, hepatocellular carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 8 Nov 2022 (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.
Non-intervention observation to evaluate the safety and efficacy of immune checkpoint inhibitors alone or combined with molecular targeted drugs / local interventional therapy in patients with advanced liver cancer, and to provide the best choice for the treatment of patients with advanced liver cancer in different stages.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunotherapy group | – | Drug: Immune checkpoint inhibitorTreatment based on immunotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients aged from 18 to 75 years old were diagnosed as hepatocellular carcinoma by pathological diagnosis and were in stage C of BCLC.
Key inclusion criteria (11 listed)
- Written informed consent must be obtained prior to any screening procedures.
- Cytohistological confirmation is required for diagnosis of HCC.
- Patients with advanced (unresectable and/or metastatic, stage C based on Barcelona-Clinic Liver Cancer [BCLC] staging classification) hepatocellular carcinoma which would not be suitable for treatment with loco-regional therapies or have progressed following locoregional therapy such as surgical resection, percutaneous hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy.
- At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
- Current cirrhotic status of Child-Pugh class A-B, with no encephalopathy. Ascites controlled by diuretics is permitted in this study.
Key exclusion criteria (13 listed)
- Received any prior systemic chemotherapy or molecular-targeted therapy for HCC such as sorafenib, lenvatinib.
- Previous local therapy completed less than 4 weeks prior to the dosing and, if present any related acute toxicity > grade 1.
- Any contraindications for Immune checkpoint inhibitor procedure
- Renal failure / insufficiency requiring hemo-or peritoneal dialysis.
- Known severe atheromatosis.
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 |
|---|---|---|
| Immune checkpoint inhibitorAfter signing the written informed consent form, patients begin to receive single or combined therapy with immune checkpoint inhibitor. The use of immune checkpoint inhibitors takes 3 weeks as a cycle, and the treatment dose for each cycle is carried out in accordance with the latest international authoritative guidelines. | Drug | Immunotherapy group |
Primary outcome
Overall Survival
Time frame: 3-years Followed up
Absence of death of any cause
2 secondary outcomes
Tumor Response
Time frame: 3-years Followed up
Progress Free Survival
Time frame: 3-years Followed up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Results publication: PubMed 34905388Lyu N, Wang X, Li JB, Lai JF, Chen QF, Li SL, Deng HJ, He M, Mu LW, Zhao M. Arterial Chemotherapy of Oxaliplatin Plus Fluorouracil Versus Sorafenib in Advanced Hepatocellular Carcinoma: A Biomolecular Exploratory, Randomized, Phase III Trial (FOHAIC-1). J Clin Oncol. 2022 Feb 10;40(5):468-480. doi: 10.1200/JCO.21.01963. Epub 2021 Dec 14.
- Results publication: PubMed 29471013Lyu N, Kong Y, Mu L, Lin Y, Li J, Liu Y, Zhang Z, Zheng L, Deng H, Li S, Xie Q, Guo R, Shi M, Xu L, Cai X, Wu P, Zhao M. Hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin vs. sorafenib for advanced hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):60-69. doi: 10.1016/j.jhep.2018.02.008. Epub 2018 Feb 20.
- Individual participant dataSharing planned: No
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.
Ming Zhao, M.D. & Ph.D. principal investigator
Department of Minimally Invasive and Interventional Radiology, Liver Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Checkpoint Inhibitor Monotherapy or Combined With Molecular Targeting Drugs / Locoregional Therapy for Hepatocellular Carcinoma, run by Sun Yat-sen University 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 11 inclusion and 13 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 31 Jan 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.
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 Ming Zhao, M.D. & Ph.D. (+86-20-87343272, zhaoming@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 3-years Followed up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05609695, which also lists 2 linked publications.
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 31 Jan 2023.