Hepatocellular CarcinomaNCT05002452
Observational Study of Factors Predicting Therapeutic Effects and Clinical Prognosis After HAIC for Locally Advanced HCC
An observational study of Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
Prospective single arm, single center observational study to evaluate factors which were easily available from preoperative examination for predicting therapeutic effects and clinical prognosis of hepatic artery infusion chemotherapy (HAIC) for hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Search of factors predicting therapeutic effects and prognosis
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2021to 1 Dec 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: Patients which are diagnosed with locally advanced HCC will receive standard HAIC and follow-up exclusively as routinely done.
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. Lesions previously treated with local therapy, such as radiation therapy, hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy should not be selected unless progression is noted at baseline, in which case, these lesions would be considered as non-target lesions.
- 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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- Eastern 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 hepatic arterial infusion procedure:
- Impaired clotting test (platelet count < 60000/mm3, prothrombin activity < 50%).
- Renal failure / insufficiency requiring hemo-or peritoneal dialysis.
- Known severe atheromatosis.
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- Known uncontrolled blood hypertension (> 160/100 mm/Hg).
- 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.
- Clinically significant (CTC grade 3 or 4) venous or arterial thrombotic disease within past 6 months.
- History of cardiac disease:
- Congestive heart failure >New York Heart Association (NYHA) class 2 (refer to Appendix 13.9).
- Active coronary artery disease (CAD) (myocardial infarction more than 6 months prior to study entry is allowed).
- Cardiac arrhythmias (>Grade 2 NCI-CTCAE Version 4.0) which are poorly controlled with anti-arrhythmic therapy or requiring pace maker.
- Uncontrolled blood hypertension (> 160/100 mm/Hg).
- Serious, non-healing wound, ulcer, or bone fracture.
- History of abdominal fistula, GI perforation, or intra-abdominal abscess within past 6 months prior to study treatment.
- Clinically significant third space fluid accumulation (i.e., ascites requiring tapping despite use of diuretic or pleural effusion that either required tapping or is associated with shortness of breath).
- Patients who have undergone major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks of the start of protocol treatment.
- History of a bone marrow or solid organ transplant.
- Use of biologic response modifiers, such as G-colony stimulating factor (CSF), within 3 weeks prior to start of study drug. (G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator; however, they may not be substituted for a required dose reduction). Subjects taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 1 month prior to the study or during the study.
- 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.
- Unable to undergo either contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT).
- Known history of human immunodeficiency virus (HIV) seropositivity. HIV testing is not required as part of this study.
- 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, 1 recruiting
- Recruiting
Department of Minimally Invasive and Interventional Radiology, Liver Cancer Study and Service Group, Sun Yat-sen University Cancer Center,
Guangzhou, Guangdong, 500060
Ming Zhao, MD, 86-20-87343272, zhaoming@sysucc.org.cn
About this study
Official title: Observational Study of Factors Predicting Therapeutic Effects and Clinical Prognosis After Hepatic Artery Infusion Chemotherapy (HAIC) for Locally Advanced Hepatocellular Carcinoma (HCC)
Prospective single arm, single center observational study to evaluate factors which were easily available from preoperative examination for predicting therapeutic effects and clinical prognosis of hepatic artery infusion chemotherapy (HAIC) for hepatocellular carcinoma. There factors are collected in preoperative routine blood examination, preoperative radiological imaging and pathological examination. Patients which are diagnosed with locally advanced hepatocellular carcinoma (HCC) will receive standard HAIC and follow-up exclusively as routinely done.
Read the detailed description
Hepatocellular carcinoma (HCC) remains a global health challenge and its incidence is growing worldwide. About 60%-70% of HCC patients were locally advanced or metastatic disease at the initial diagnosis, with a poor prognosis causing by unavailability of potentially curative therapies. Therefore, treatments that can control the progression and improve the prognosis of advanced HCC are under great need in sufficient liver reservation. Recent studies have shown that hepatic arterial infusion chemotherapy (HAIC) is beneficial to patients with locally advanced HCC. These studies have demonstrated that HAIC is superior to Sorafinib for the treatment of HCC with PVTT, whereas Sorafinib is recommended as first line treatment for locally advanced HCC. Therefore, HAIC is an important treatment option for locally advanced HCC. However, current tumor staging and prediction models for predicting the prognosis of HAIC for HCC is still unconvincing, and we found that some factors which were easily available from routine preoperative examination might be related to therapeutic effects and prognosis of HAIC for HCC. Thus, this prospective observational study aims to evaluate the value of these indicators for predicting therapeutic effects and prognosis of HAIC for HCC.
The standard procedure for HAIC is that femoral artery puncture and catheterization are performed in every cycle of treatment, a micro-catheter is inserted and located in feeding hepatic artery. The therapeutic scheme is modified FOLFOX6 regimens including oxaliplatin (130 mg/m2 infusion for 3 hours on day 1), leucovorin (200 mg/m2 from hour 3 to 5 on day 1) and Fluorouracil (400 mg/m2 in bolus, and then 2,400 mg/m2 continuous infusion 46 hours). All chemo-drugs are given by HAI. Treatment was repeated every 3 weeks and continued until intrahepatic lesions progression or unacceptable toxicity. Enhanced CT or MRI was performed every 6 weeks after treatment begins. Routine follow-up intervals were 2-4 months.
Before treatment, each patient will undergo routine hematological examinations which include blood routine, biochemical routine, coagulation routine, HCC related tumor markers. A three-phases enhanced CT or MR scan and biopsy of intrahepatic mass are performed before HAIC. Some factors through these examinations are collected and used to evaluate the relation of postoperative response rate and survival.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Search of factors predicting therapeutic effects and prognosis
- Keywords
- Arterial infusion chemotherapy, FOLFOX
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Search of factors predicting therapeutic effects and prognosisOther
There factors are collected in preoperative routine blood examination, preoperative radiological imaging and pathological examination.
| Study group | Role | What they receive |
|---|---|---|
| Locally Advanced HCC Patients | Patients which are diagnosed with locally advanced hepatocellular carcinoma (HCC) will receive standard HAIC treatment. Receives: Other: Search of factors predicting therapeutic effects and prognosis |
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
Tumor Response
Tumor response to HAIC according to RECIST 1.1
Measured: 3-years Followed up
Secondary outcomes (4)
Progress Free Survival
Absence of disease progression other than death
Measured: 3-years Followed up
Tumor local control
Absence of regrowth inside the treated lesion
Measured: 3-years Followed up
Hepatic control
Absence of regrowth or onset of new lesions inside the liver
Measured: 3-years Followed up
Distant control
Absence of extrahepatic progression
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 posted12 Aug 2021
- Study start20 Dec 2021
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Dec 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 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
- 150 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., Principal investigator, Department of Minimally Invasive and Interventional Radiology, Liver Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002452
- Sponsor's protocol ID
- B2021-107-01
- Status last verified
- Jun 2022
- First submitted
- 7 Aug 2021
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lyu 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 29471013Lyu N, Lin Y, Kong Y, Zhang Z, Liu L, Zheng L, Mu L, Wang J, Li X, Pan T, Xie Q, Liu Y, Lin A, Wu P, Zhao M. FOXAI: a phase II trial evaluating the efficacy and safety of hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin for advanced hepatocellular carcinoma. Gut. 2018 Feb;67(2):395-396. doi: 10.1136/gutjnl-2017-314138. Epub 2017 Jun 7. No abstract available.
PubMed 28592441
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Factors Predicting Therapeutic Effects and Clinical Prognosis After Hepatic Artery Infusion Chemotherapy (HAIC) for Locally Advanced Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT05002452
- Acronym / sponsor ID
- B2021-107-01
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Arterial infusion chemotherapy, FOLFOX
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 12 Aug 2021 (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.
Prospective single arm, single center observational study to evaluate factors which were easily available from preoperative examination for predicting therapeutic effects and clinical prognosis of hepatic artery infusion chemotherapy (HAIC) for hepatocellular carcinoma. There factors are collected in preoperative routine blood examination, preoperative radiological imaging and pathological examination. Patients which are diagnosed with locally advanced hepatocellular carcinoma (HCC) will receive standard HAIC and follow-up exclusively as routinely done.
Detailed description
Hepatocellular carcinoma (HCC) remains a global health challenge and its incidence is growing worldwide. About 60%-70% of HCC patients were locally advanced or metastatic disease at the initial diagnosis, with a poor prognosis causing by unavailability of potentially curative therapies. Therefore, treatments that can control the progression and improve the prognosis of advanced HCC are under great need in sufficient liver reservation. Recent studies have shown that hepatic arterial infusion chemotherapy (HAIC) is beneficial to patients with locally advanced HCC. These studies have demonstrated that HAIC is superior to Sorafinib for the treatment of HCC with PVTT, whereas Sorafinib is recommended as first line treatment for locally advanced HCC. Therefore, HAIC is an important treatment option for locally advanced HCC. However, current tumor staging and prediction models for predicting the prognosis of HAIC for HCC is still unconvincing, and we found that some factors which were easily available from routine preoperative examination might be related to therapeutic effects and prognosis of HAIC for HCC. Thus, this prospective observational study aims to evaluate the value of these indicators for predicting therapeutic effects and prognosis of HAIC for HCC.
The standard procedure for HAIC is that femoral artery puncture and catheterization are performed in every cycle of treatment, a micro-catheter is inserted and located in feeding hepatic artery. The therapeutic scheme is modified FOLFOX6 regimens including oxaliplatin (130 mg/m2 infusion for 3 hours on day 1), leucovorin (200 mg/m2 from hour 3 to 5 on day 1) and Fluorouracil (400 mg/m2 in bolus, and then 2,400 mg/m2 continuous infusion 46 hours). All chemo-drugs are given by HAI. Treatment was repeated every 3 weeks and continued until intrahepatic lesions progression or unacceptable toxicity. Enhanced CT or MRI was performed every 6 weeks after treatment begins. Routine follow-up intervals were 2-4 months.
Before treatment, each patient will undergo routine hematological examinations which include blood routine, biochemical routine, coagulation routine, HCC related tumor markers. A three-phases enhanced CT or MR scan and biopsy of intrahepatic mass are performed before HAIC. Some factors through these examinations are collected and used to evaluate the relation of postoperative response rate and survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Locally Advanced HCC Patients | – | Other: Search of factors predicting therapeutic effects and prognosisPatients which are diagnosed with locally advanced hepatocellular carcinoma (HCC) will receive standard HAIC treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients which are diagnosed with locally advanced HCC will receive standard HAIC and follow-up exclusively as routinely done.
Key inclusion criteria (19 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. Lesions previously treated with local therapy, such as radiation therapy, hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy should not be selected unless progression is noted at baseline, in which case, these lesions would be considered as non-target lesions.
- Current cirrhotic status of Child-Pugh class A-B, with no encephalopathy. Ascites controlled by diuretics is permitted in this study.
Key exclusion criteria (28 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 hepatic arterial infusion procedure:
- Impaired clotting test (platelet count < 60000/mm3, prothrombin activity < 50%).
- Renal failure / insufficiency requiring hemo-or peritoneal dialysis.
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 |
|---|---|---|
| Search of factors predicting therapeutic effects and prognosisThere factors are collected in preoperative routine blood examination, preoperative radiological imaging and pathological examination. | Other | Locally Advanced HCC Patients |
Primary outcome
Overall Survival
Time frame: 3-years Followed up
Absence of death of any cause
Tumor Response
Time frame: 3-years Followed up
Tumor response to HAIC according to RECIST 1.1
4 secondary outcomes
Progress Free Survival
Time frame: 3-years Followed up
Tumor local control
Time frame: 3-years Followed up
Hepatic control
Time frame: 3-years Followed up
Distant control
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 8 Jun 2022.
- Background: 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.
- Background: PubMed 28592441Lyu N, Lin Y, Kong Y, Zhang Z, Liu L, Zheng L, Mu L, Wang J, Li X, Pan T, Xie Q, Liu Y, Lin A, Wu P, Zhao M. FOXAI: a phase II trial evaluating the efficacy and safety of hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin for advanced hepatocellular carcinoma. Gut. 2018 Feb;67(2):395-396. doi: 10.1136/gutjnl-2017-314138. Epub 2017 Jun 7. No abstract available.
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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.
Ming Zhao, M.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 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 19 inclusion and 28 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 8 Jun 2022. 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. (+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). 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?
On the ClinicalTrials.gov record for NCT05002452, 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 8 Jun 2022.