Hepatic Cell CarcinomaEarly Phase 1NCT04048317
Effectiveness of Drug Eluting TACE in Primary HCC
A Early Phase 1 study testing HepaSphere Microspheres/Doxorubicin Hydrochloride and Lipiodol in people with Hepatic Cell Carcinoma, run by Assiut University.
Trial summary
the aim of this work to compare effectiveness of drug-eluting bead trans-arterial chemo-embolization and conventional trans-arterial chemo-embolization of hepatic cell carcinoma in the aspect of (Tumor response via m-RECIST criteria), (liver injury via Liver function tests and tumor markers) and (survival outcome) of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatic Cell Carcinoma
- What is being tested?
- HepaSphere Microspheres/Doxorubicin Hydrochloride and Lipiodol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 1 Dec 2020
- Phase
- Early Phase 1
- 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
- patients must be 18 to 75 years old.
- patients must be diagnosed as primary Hepatocellular carcinoma (HCC) by radiologic imaging revealed angiogenicity pattern .
- All of the patient have Child-Pugh status A or B .
- All of the patient have BCLC stage A or B.
- patients must have adequate renal and liver function accepting the maneuver.
- patients must have adequate coagulation profile (platelets count ≥ 80 000), (prothrombin concentration ≥ 70 %).
- patients must haven't previous history of resection of other ablation (alcohol, radio frequency or micro wave ablation).
Who cannot join
- patients have previous history of resection of other ablation (alcohol, radio frequency or micro wave ablation).
- patients with impaired coagulation profile (platelets count < 80 000), (prothrombin concentration < 70 %).
- patients with decompensated liver cell failure having ascites which impedes the maneuver .
- patients with past history of reaction to the drug used in maneuver
- patients with poor image quality.
- patients with lost follow up .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Drug Eluting & Conventional Trans-arterial Chemo-embolization in Treatment of Primary Hepatic Cell Carcinoma
the aim of this work to compare effectiveness of drug-eluting bead trans-arterial chemo-embolization and conventional trans-arterial chemo-embolization of hepatic cell carcinoma in the aspect of (Tumor response via m-RECIST criteria), (liver injury via Liver function tests and tumor markers) and (survival outcome) of patients treated in Assiut university .
Read the detailed description
Hepatocellular carcinoma (HCC) is the sixth most common cancer in the world and the third most common cause of cancer-related death .. With improved surveillance of patients with chronic liver disease and advances in imaging, more patients are diagnosed with early-stage HCC . For the treatment of early stage HCC, curative therapies including liver transplantation, hepatic resection, and radio frequency ablation (RFA) are recommended. Liver transplantation is the treatment option especially for patients with decompensated cirrhosis, but potential recipients outnumber donors. Hepatic resection is widely used as the main choice of treatment for resectable HCC. However, the risk of postoperative hepatic dysfunction often precludes surgery.
For unresectable patient, trans-arterial chemo-embolization (TACE) was the treatment of choice .
At 2014, Yang et al. compared the treatment effects of hepatic resection, RFA, and conventional TACE on long-term survival. It was found that the range of patients treated by TACE in clinical practice reported survivals widely range from 8-26% at 5-years. which was similar to that with hepatic resection and RFA in patients with single-nodule HCC of 3 cm or smaller without vascular invasion when the underlying liver status was balanced among the patients receiving each treatment. In addition, most of the patients initially treated with c-TACE achieved a complete response, which was one of the independent prognostic factors of survival, although some should receive repeated treatments. However, when c-TACE is used as an initial treatment, special care should be taken to obtain a complete response, and surveillance for tumor recurrence should be undertaken. These results are consistent with those of cohort studies demonstrating that TACE provided overall survival similar to hepatic resection in early-stage HCC .
Conventional (Lipiodol) TACE Base on technique with emulsified combination of chemotherapy such as Doxorubicin and Lipiodol administrate via arterial feeder.
Less in systemic chemotherapy and increase overall survival rate were the most concern in treatment but many studies reported side effects from conventional (Lipiodol) TACE significantly among an improvement of overall survival rate .
Conventional TACE may cause side effects because it can damage healthy cells as it kills cancer cells. Side effects can develop any time during, immediately after or a few days or weeks after chemotherapy . in addition to the patient needed frequent ablation after a short time .
The most commonly Side Effect of TACE is (Post embolization syndrome) which is a group of symptoms . include : fever, Right upper quadrant pain, nausea, vomiting and fatigue .
Other side effects may occur include bruising or bleeding at the catheter site, hair loss, abnormal liver functions, lung infections, gall bladder inflammation and tumor lysis syndrome .
Drug-eluting bead TACE is the new method of delivering chemotherapy during TACE which uses special beads that already have the chemotherapy drug in them . after these are injected into the arteries of the liver , they slowly sustained releasing the drug to treat the tumor .
The studies showed that TACE with (Hepasphere) less systemic side effect in patient than TACE with (Lipiodol) but no definite statistical difference in treatment and survival outcome.
This study compares effectiveness of those methods in treatment of Hepatocellular carcinoma in Assiut university
- Conditions
- Hepatic Cell Carcinoma
- Being tested
- HepaSphere Microspheres/Doxorubicin Hydrochloride, Lipiodol
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepaSphere Microspheres/Doxorubicin HydrochlorideDrug
evaluation the tumor (size, location and pattern of enhancement) ;and ensure portal vein patency; then evaluation of hepatic arterial anatomy, after that we determine the tumor arterial feeders and the arteries that should be avoided during the maneuver.
Selective celiac and superior mesenteric angiograms were performed using 5 Fr. Catheter then superselective angiogram were used microcatheter. then injection of drug-eluting microsphere (25 mg Hepasphere 50-100 micron) loaded with 50 mg doxorubicin solution for 2 hours.
LipiodolDrug
evaluation the tumor (size, location and pattern of enhancement) ;and ensure portal vein patency; then evaluation of hepatic arterial anatomy, after that we determine the tumor arterial feeders and the arteries that should be avoided during the maneuver.
Selective celiac and superior mesenteric angiograms were performed using 5 Fr. Catheter then superselective angiogram were used microcatheter. then injection of prepared mixture of Lipiodol and (Doxorubicin or 5-FU) vary in dosage depend on operator consideration
| Study group | Role | What they receive |
|---|---|---|
| drug eluting bead trans arterial chemo embolization | Experimental | the international arm is the patients embolized with drug eluting bead trans arterial chemo embolization using Hepasphere Receives: Drug: HepaSphere Microspheres/Doxorubicin Hydrochloride |
| conventional trans arterial chemo embolization | Placebo comparator | the control arm is the patients embolized with drug eluting bead trans arterial chemo embolization using Lipiodol Receives: Drug: Lipiodol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of drug-eluting bead trans-arterial chemo-embolization in patients of hepatocellular carcinoma
Evaluate the efficacy and safety of drug-eluting bead trans-arterial chemo-embolization in management of HCC patients in comparison of conventional chemo-embolization in 75 stable patients by evaluating the response of embolized lesions for each drug with modified RECIST criteria.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hepatic Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Hassan Taha Abdurabou, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048317
- Sponsor's protocol ID
- effectiveness of TACE
- Status last verified
- Aug 2019
- First submitted
- 26 Jul 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
PubMed 25220842Kudo M, Izumi N, Kokudo N, Matsui O, Sakamoto M, Nakashima O, Kojiro M, Makuuchi M; HCC Expert Panel of Japan Society of Hepatology. Management of hepatocellular carcinoma in Japan: Consensus-Based Clinical Practice Guidelines proposed by the Japan Society of Hepatology (JSH) 2010 updated version. Dig Dis. 2011;29(3):339-64. doi: 10.1159/000327577. Epub 2011 Aug 9.
PubMed 21829027Zhang BH, Yang BH, Tang ZY. Randomized controlled trial of screening for hepatocellular carcinoma. J Cancer Res Clin Oncol. 2004 Jul;130(7):417-22. doi: 10.1007/s00432-004-0552-0.
PubMed 15042359Yang HJ, Lee JH, Lee DH, Yu SJ, Kim YJ, Yoon JH, Kim HC, Lee JM, Chung JW, Yi NJ, Lee KW, Suh KS, Lee HS. Small single-nodule hepatocellular carcinoma: comparison of transarterial chemoembolization, radiofrequency ablation, and hepatic resection by using inverse probability weighting. Radiology. 2014 Jun;271(3):909-18. doi: 10.1148/radiol.13131760. Epub 2014 Feb 8.
PubMed 24520944Salem R, Lewandowski RJ. Chemoembolization and radioembolization for hepatocellular carcinoma. Clin Gastroenterol Hepatol. 2013 Jun;11(6):604-11; quiz e43-4. doi: 10.1016/j.cgh.2012.12.039. Epub 2013 Jan 26.
PubMed 23357493Hsu CY, Huang YH, Chiou YY, Su CW, Lin HC, Lee RC, Chiang JH, Huo TI, Lee FY, Lee SD. Comparison of radiofrequency ablation and transarterial chemoembolization for hepatocellular carcinoma within the Milan criteria: a propensity score analysis. Liver Transpl. 2011 May;17(5):556-66. doi: 10.1002/lt.22273.
PubMed 21506244Guo Z, Zhong Y, Hu B, Jiang JH, Li LQ, Xiang BD. Hepatic resection or transarterial chemoembolization for hepatocellular carcinoma within Milan criteria: A propensity score matching analysis. Medicine (Baltimore). 2017 Dec;96(51):e8933. doi: 10.1097/MD.0000000000008933.
PubMed 29390426Dhanasekaran R, Kooby DA, Staley CA, Kauh JS, Khanna V, Kim HS. Prognostic factors for survival in patients with unresectable hepatocellular carcinoma undergoing chemoembolization with doxorubicin drug-eluting beads: a preliminary study. HPB (Oxford). 2010 Apr;12(3):174-80. doi: 10.1111/j.1477-2574.2009.00138.x.
PubMed 20590884Lammer J, Malagari K, Vogl T, Pilleul F, Denys A, Watkinson A, Pitton M, Sergent G, Pfammatter T, Terraz S, Benhamou Y, Avajon Y, Gruenberger T, Pomoni M, Langenberger H, Schuchmann M, Dumortier J, Mueller C, Chevallier P, Lencioni R; PRECISION V Investigators. Prospective randomized study of doxorubicin-eluting-bead embolization in the treatment of hepatocellular carcinoma: results of the PRECISION V study. Cardiovasc Intervent Radiol. 2010 Feb;33(1):41-52. doi: 10.1007/s00270-009-9711-7. Epub 2009 Nov 12.
PubMed 19908093Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010 Feb;30(1):52-60. doi: 10.1055/s-0030-1247132. Epub 2010 Feb 19.
PubMed 20175033
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Drug Eluting & Conventional Trans-arterial Chemo-embolization in Treatment of Primary Hepatic Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04048317
- Acronym / sponsor ID
- effectiveness of TACE
- Conditions
- Hepatic Cell Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 7 Aug 2019 (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 aim of this work to compare effectiveness of drug-eluting bead trans-arterial chemo-embolization and conventional trans-arterial chemo-embolization of hepatic cell carcinoma in the aspect of (Tumor response via m-RECIST criteria), (liver injury via Liver function tests and tumor markers) and (survival outcome) of patients treated in Assiut university .
Detailed description
Hepatocellular carcinoma (HCC) is the sixth most common cancer in the world and the third most common cause of cancer-related death .. With improved surveillance of patients with chronic liver disease and advances in imaging, more patients are diagnosed with early-stage HCC . For the treatment of early stage HCC, curative therapies including liver transplantation, hepatic resection, and radio frequency ablation (RFA) are recommended. Liver transplantation is the treatment option especially for patients with decompensated cirrhosis, but potential recipients outnumber donors. Hepatic resection is widely used as the main choice of treatment for resectable HCC. However, the risk of postoperative hepatic dysfunction often precludes surgery.
For unresectable patient, trans-arterial chemo-embolization (TACE) was the treatment of choice .
At 2014, Yang et al. compared the treatment effects of hepatic resection, RFA, and conventional TACE on long-term survival. It was found that the range of patients treated by TACE in clinical practice reported survivals widely range from 8-26% at 5-years. which was similar to that with hepatic resection and RFA in patients with single-nodule HCC of 3 cm or smaller without vascular invasion when the underlying liver status was balanced among the patients receiving each treatment. In addition, most of the patients initially treated with c-TACE achieved a complete response, which was one of the independent prognostic factors of survival, although some should receive repeated treatments. However, when c-TACE is used as an initial treatment, special care should be taken to obtain a complete response, and surveillance for tumor recurrence should be undertaken. These results are consistent with those of cohort studies demonstrating that TACE provided overall survival similar to hepatic resection in early-stage HCC .
Conventional (Lipiodol) TACE Base on technique with emulsified combination of chemotherapy such as Doxorubicin and Lipiodol administrate via arterial feeder.
Less in systemic chemotherapy and increase overall survival rate were the most concern in treatment but many studies reported side effects from conventional (Lipiodol) TACE significantly among an improvement of overall survival rate .
Conventional TACE may cause side effects because it can damage healthy cells as it kills cancer cells. Side effects can develop any time during, immediately after or a few days or weeks after chemotherapy . in addition to the patient needed frequent ablation after a short time .
The most commonly Side Effect of TACE is (Post embolization syndrome) which is a group of symptoms . include : fever, Right upper quadrant pain, nausea, vomiting and fatigue .
Other side effects may occur include bruising or bleeding at the catheter site, hair loss, abnormal liver functions, lung infections, gall bladder inflammation and tumor lysis syndrome .
Drug-eluting bead TACE is the new method of delivering chemotherapy during TACE which uses special beads that already have the chemotherapy drug in them . after these are injected into the arteries of the liver , they slowly sustained releasing the drug to treat the tumor .
The studies showed that TACE with (Hepasphere) less systemic side effect in patient than TACE with (Lipiodol) but no definite statistical difference in treatment and survival outcome.
This study compares effectiveness of those methods in treatment of Hepatocellular carcinoma in Assiut university
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drug eluting bead trans arterial chemo embolization | Experimental | Drug: HepaSphere Microspheres/Doxorubicin Hydrochloridethe international arm is the patients embolized with drug eluting bead trans arterial chemo embolization using Hepasphere |
| conventional trans arterial chemo embolization | Placebo comparator | Drug: Lipiodolthe control arm is the patients embolized with drug eluting bead trans arterial chemo embolization using Lipiodol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients must be 18 to 75 years old.
- patients must be diagnosed as primary Hepatocellular carcinoma (HCC) by radiologic imaging revealed angiogenicity pattern .
- All of the patient have Child-Pugh status A or B .
- All of the patient have BCLC stage A or B.
- patients must have adequate renal and liver function accepting the maneuver.
Key exclusion criteria (6 listed)
- patients have previous history of resection of other ablation (alcohol, radio frequency or micro wave ablation).
- patients with impaired coagulation profile (platelets count < 80 000), (prothrombin concentration < 70 %).
- patients with decompensated liver cell failure having ascites which impedes the maneuver .
- patients with past history of reaction to the drug used in maneuver
- patients with poor image quality.
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 |
|---|---|---|
| HepaSphere Microspheres/Doxorubicin Hydrochlorideevaluation the tumor (size, location and pattern of enhancement) ;and ensure portal vein patency; then evaluation of hepatic arterial anatomy, after that we determine the tumor arterial feeders and the arteries that should be avoided during the maneuver. Selective celiac and superior mesenteric angiograms were performed using 5 Fr. Catheter then superselective angiogram were used microcatheter. then injection of drug-eluting microsphere (25 mg Hepasphere 50-100 micron) loaded with 50 mg doxorubicin solution for 2 hours. | Drug | drug eluting bead trans arterial chemo embolization |
| Lipiodolevaluation the tumor (size, location and pattern of enhancement) ;and ensure portal vein patency; then evaluation of hepatic arterial anatomy, after that we determine the tumor arterial feeders and the arteries that should be avoided during the maneuver. Selective celiac and superior mesenteric angiograms were performed using 5 Fr. Catheter then superselective angiogram were used microcatheter. then injection of prepared mixture of Lipiodol and (Doxorubicin or 5-FU) vary in dosage depend on operator consideration | Drug | conventional trans arterial chemo embolization |
Primary outcome
Evaluate the effectiveness of drug-eluting bead trans-arterial chemo-embolization in patients of hepatocellular carcinoma
Time frame: baseline
Evaluate the efficacy and safety of drug-eluting bead trans-arterial chemo-embolization in management of HCC patients in comparison of conventional chemo-embolization in 75 stable patients by evaluating the response of embolized lesions for each drug with modified RECIST criteria.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Background: PubMed 25220842Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
- Background: PubMed 21829027Kudo M, Izumi N, Kokudo N, Matsui O, Sakamoto M, Nakashima O, Kojiro M, Makuuchi M; HCC Expert Panel of Japan Society of Hepatology. Management of hepatocellular carcinoma in Japan: Consensus-Based Clinical Practice Guidelines proposed by the Japan Society of Hepatology (JSH) 2010 updated version. Dig Dis. 2011;29(3):339-64. doi: 10.1159/000327577. Epub 2011 Aug 9.
- Background: PubMed 15042359Zhang BH, Yang BH, Tang ZY. Randomized controlled trial of screening for hepatocellular carcinoma. J Cancer Res Clin Oncol. 2004 Jul;130(7):417-22. doi: 10.1007/s00432-004-0552-0.
- Background: PubMed 24520944Yang HJ, Lee JH, Lee DH, Yu SJ, Kim YJ, Yoon JH, Kim HC, Lee JM, Chung JW, Yi NJ, Lee KW, Suh KS, Lee HS. Small single-nodule hepatocellular carcinoma: comparison of transarterial chemoembolization, radiofrequency ablation, and hepatic resection by using inverse probability weighting. Radiology. 2014 Jun;271(3):909-18. doi: 10.1148/radiol.13131760. Epub 2014 Feb 8.
- Background: PubMed 23357493Salem R, Lewandowski RJ. Chemoembolization and radioembolization for hepatocellular carcinoma. Clin Gastroenterol Hepatol. 2013 Jun;11(6):604-11; quiz e43-4. doi: 10.1016/j.cgh.2012.12.039. Epub 2013 Jan 26.
- Background: PubMed 21506244Hsu CY, Huang YH, Chiou YY, Su CW, Lin HC, Lee RC, Chiang JH, Huo TI, Lee FY, Lee SD. Comparison of radiofrequency ablation and transarterial chemoembolization for hepatocellular carcinoma within the Milan criteria: a propensity score analysis. Liver Transpl. 2011 May;17(5):556-66. doi: 10.1002/lt.22273.
- Background: PubMed 29390426Guo Z, Zhong Y, Hu B, Jiang JH, Li LQ, Xiang BD. Hepatic resection or transarterial chemoembolization for hepatocellular carcinoma within Milan criteria: A propensity score matching analysis. Medicine (Baltimore). 2017 Dec;96(51):e8933. doi: 10.1097/MD.0000000000008933.
- Background: PubMed 20590884Dhanasekaran R, Kooby DA, Staley CA, Kauh JS, Khanna V, Kim HS. Prognostic factors for survival in patients with unresectable hepatocellular carcinoma undergoing chemoembolization with doxorubicin drug-eluting beads: a preliminary study. HPB (Oxford). 2010 Apr;12(3):174-80. doi: 10.1111/j.1477-2574.2009.00138.x.
- Background: PubMed 19908093Lammer J, Malagari K, Vogl T, Pilleul F, Denys A, Watkinson A, Pitton M, Sergent G, Pfammatter T, Terraz S, Benhamou Y, Avajon Y, Gruenberger T, Pomoni M, Langenberger H, Schuchmann M, Dumortier J, Mueller C, Chevallier P, Lencioni R; PRECISION V Investigators. Prospective randomized study of doxorubicin-eluting-bead embolization in the treatment of hepatocellular carcinoma: results of the PRECISION V study. Cardiovasc Intervent Radiol. 2010 Feb;33(1):41-52. doi: 10.1007/s00270-009-9711-7. Epub 2009 Nov 12.
- Background: PubMed 20175033Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin Liver Dis. 2010 Feb;30(1):52-60. doi: 10.1055/s-0030-1247132. Epub 2010 Feb 19.
- Hepatic Arterial Infusion of Doxorubicin-Loaded Microsphere for Treatment of Hepatocellular Cancer: A Multi-Institutional RegistryLink provided by the sponsor.
- 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 Early Phase 1 study testing HepaSphere Microspheres/Doxorubicin Hydrochloride and Lipiodol in people with Hepatic Cell Carcinoma, run by Assiut University.
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 7 inclusion and 6 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 7 Aug 2019. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Ahmed M. Abdurabou, resident (00201149112036, ahmedabdurabou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effectiveness of drug-eluting bead trans-arterial chemo-embolization in patients of hepatocellular carcinoma (time frame: baseline). 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 NCT04048317, which also lists 10 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 7 Aug 2019.