Hepatocellular CarcinomaPhase 3NCT03974074
Albumin for Hepatocellular Carcinoma
A Phase 3 study testing Albumin infusion in people with Hepatocellular Carcinoma and Hypoproteinemia, run by Guangxi Medical University at 2 sites in China.
Trial summary
The rate of liver cirrhosis is about 40% to 75% among patients with hepatocellular carcinoma (HCC). Therefore, many patients with HCC were with low serum albumin before and after (especially) hepatic resection. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma, Hypoproteinemia
- What is being tested?
- Albumin infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2019to 31 Dec 2020
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index >18.5;
- Patients with primary hepatocellular carcinoma without any treatments for tumors before resection;
- Hepatocellular carcinoma should be confirmed by histopathology;
- With preserved liver function (Child-Pugh score ≤7) before resection
- ECOG performance score 0 or 1;
- Preoperative serum albumin >35g/L;
- The level of postoperative serum albumin is between 25-30g/L in the first day after resection.
Who cannot join
- Patients used albumin before liver resection (<1 months);
- Plasma was used during or after liver resection;
- Surgery involving the extrahepatic bile duct or gastrointestinal tract.
Trial locations and contacts
2 sites in 1 country.
Bang-De Xiang, PdD contact
China2 sites, 2 recruiting
- Recruiting
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Jian-Hong Zhong, PdD, zhongjianhong@gxmu.edu.cn
- Not yet recruiting
Jian-Hong Zhong
Nanning, Guangxi, 530021
Jian-Hong Zhong, 771 5330855, zhongjianhong@gxmu.edu.cn
About this study
Official title: Albumin Infusion for Patients With Hepatocellular Carcinoma and Hypoproteinemia After Hepatectomy
The rate of liver cirrhosis is about 40% to 75% among patients with hepatocellular carcinoma (HCC). Therefore, many patients with HCC were with low serum albumin before and after (especially) hepatic resection. Serum albumin level has been routinely used in clinical practice as a surrogate marker to evaluate nutritional status and liver function. Serum albumin concentration is used as an independent mortality risk predictor in a broad range of clinical and research settings. However, the role of albumin infusion in patients with hepatocellular carcinoma (HCC) after resection is unknown. The present study aimed to investigate the safety and clinical necessity of albumin infusion for HCC patients after hepatic resection.
- Conditions
- Hepatocellular Carcinoma, Hypoproteinemia
- Being tested
- Albumin infusion
- Medical subject headings
- Carcinoma, Hepatocellular, Hypoproteinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin infusionDrug
Albumin infusion (20 g, ivgtt, qd) will be performed to patients with HCC after resection in 24 h for three days.
| Study group | Role | What they receive |
|---|---|---|
| Albumin infusion group | Experimental | Albumin infusion (20 g, ivgtt, qd) will be performed to patients with HCC after hepatic resection in 24 h for three days. All patients wil receive furosemide (10 mg, iv) after albumin transfusion. In the fifth day after resection, patients will receive albumin transfusion if they have ascites with shifting dullness, moderate edema (below both lower ankle joints) with serum albumin lower than 30 g/L, severe postoperation complication (septicopyemia, postoperative bleeding with reoperation, or biliary fistula). Receives: Drug: Albumin infusion |
| Empty control | No intervention | Conventional liver protection and rehydration therapy.In the fifth day after resection, patients will receive albumin transfusion if they have ascites with shifting dullness, moderate edema (below both lower ankle joints) with serum albumin lower than 30 g/L, severe postoperation complication (septicopyemia, postoperative bleeding with reoperation, or biliary fistula). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum total bilirubin level
Recovery of liver function between the two groups
Measured: Change from Baseline total bilirubin at the fifth and seventh days after resection
Serum albumin level
Recovery of liver function between the two groups
Measured: Change from Baseline serum albumin at the fifth and seventh days after resection
Secondary outcomes (2)
Abdominal girth
Drainage liquid and abdominal girth between the two groups were compared
Measured: Change from Baseline abdominal girth at the fifth and seventh days after resection
Rate of postoperative complications
The rate of postoperative complications between the two groups were compared
Measured: The first months after resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Mar 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Hong Zhong, Guangxi Medical University
- Investigators
- Wei-Zhong Tang, MD, Study director, Cancer Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974074
- Sponsor's protocol ID
- Alb-HCC
- Status last verified
- Jul 2020
- First submitted
- 30 May 2019
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
European Association for the Study of the Liver. EASL clinical practice guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis. J Hepatol. 2010 Sep;53(3):397-417. doi: 10.1016/j.jhep.2010.05.004. Epub 2010 Jun 1. No abstract available.
PubMed 20633946Pericleous M, Sarnowski A, Moore A, Fijten R, Zaman M. The clinical management of abdominal ascites, spontaneous bacterial peritonitis and hepatorenal syndrome: a review of current guidelines and recommendations. Eur J Gastroenterol Hepatol. 2016 Mar;28(3):e10-8. doi: 10.1097/MEG.0000000000000548.
PubMed 26671516
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Albumin Infusion for Patients With Hepatocellular Carcinoma and Hypoproteinemia After Hepatectomy
- ClinicalTrials.gov ID
- NCT03974074
- Acronym / sponsor ID
- Alb-HCC
- Conditions
- Hepatocellular Carcinoma, Hypoproteinemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 4 Jun 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 rate of liver cirrhosis is about 40% to 75% among patients with hepatocellular carcinoma (HCC). Therefore, many patients with HCC were with low serum albumin before and after (especially) hepatic resection. Serum albumin level has been routinely used in clinical practice as a surrogate marker to evaluate nutritional status and liver function. Serum albumin concentration is used as an independent mortality risk predictor in a broad range of clinical and research settings. However, the role of albumin infusion in patients with hepatocellular carcinoma (HCC) after resection is unknown. The present study aimed to investigate the safety and clinical necessity of albumin infusion for HCC patients after hepatic resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin infusion group | Experimental | Drug: Albumin infusionAlbumin infusion (20 g, ivgtt, qd) will be performed to patients with HCC after hepatic resection in 24 h for three days. All patients wil receive furosemide (10 mg, iv) after albumin transfusion. In the fifth day after resection, patients will receive albumin transfusion if they have ascites with shifting dullness, moderate edema (below both lower ankle joints) with serum albumin lower than 30 g/L, severe postoperation complication (septicopyemia, postoperative bleeding with reoperation, or biliary fistula). |
| Empty control | No intervention | –Conventional liver protection and rehydration therapy.In the fifth day after resection, patients will receive albumin transfusion if they have ascites with shifting dullness, moderate edema (below both lower ankle joints) with serum albumin lower than 30 g/L, severe postoperation complication (septicopyemia, postoperative bleeding with reoperation, or biliary fistula). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Body mass index >18.5;
- Patients with primary hepatocellular carcinoma without any treatments for tumors before resection;
- Hepatocellular carcinoma should be confirmed by histopathology;
- With preserved liver function (Child-Pugh score ≤7) before resection
- ECOG performance score 0 or 1;
Key exclusion criteria (3 listed)
- Patients used albumin before liver resection (<1 months);
- Plasma was used during or after liver resection;
- Surgery involving the extrahepatic bile duct or gastrointestinal tract.
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 |
|---|---|---|
| Albumin infusionAlbumin infusion (20 g, ivgtt, qd) will be performed to patients with HCC after resection in 24 h for three days. | Drug | Albumin infusion group |
Primary outcome
Serum total bilirubin level
Time frame: Change from Baseline total bilirubin at the fifth and seventh days after resection
Recovery of liver function between the two groups
Serum albumin level
Time frame: Change from Baseline serum albumin at the fifth and seventh days after resection
Recovery of liver function between the two groups
2 secondary outcomes
Abdominal girth
Time frame: Change from Baseline abdominal girth at the fifth and seventh days after resection
Rate of postoperative complications
Time frame: The first months after resection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Results publication: PubMed 20633946European Association for the Study of the Liver. EASL clinical practice guidelines on the management of ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome in cirrhosis. J Hepatol. 2010 Sep;53(3):397-417. doi: 10.1016/j.jhep.2010.05.004. Epub 2010 Jun 1. No abstract available.
- Results publication: PubMed 26671516Pericleous M, Sarnowski A, Moore A, Fijten R, Zaman M. The clinical management of abdominal ascites, spontaneous bacterial peritonitis and hepatorenal syndrome: a review of current guidelines and recommendations. Eur J Gastroenterol Hepatol. 2016 Mar;28(3):e10-8. doi: 10.1097/MEG.0000000000000548.
- Individual participant dataSharing planned: No
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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.
Bang-De Xiang, PdD contact
Wei-Zhong Tang, MD study director
Cancer Hospital of Guangxi Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albumin infusion in people with Hepatocellular Carcinoma and Hypoproteinemia, run by Guangxi Medical University at 2 sites 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 7 inclusion and 3 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 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jian-Hong Zhong, PdD (771 5330855, zhongjianhong@gxmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum total bilirubin level (time frame: Change from Baseline total bilirubin at the fifth and seventh days after resection). 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 NCT03974074, 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 22 Jul 2020.