Hepatocellular CarcinomaPhase 3NCT00460681
Study of Thymopentin in Patients After Curative Resection of Small Hepatocellular Carcinoma
A Phase 3 study testing Thymopentin in people with Hepatocellular Carcinoma, run by Fudan University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the clinical efficacy of thymopentin on the prevention of the recurrence and metastasis of small HCC after resection. 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?
- Thymopentin
- Type of treatment
- Injection or infusion
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- Feb 2007to Feb 2012
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who received curative resection of HBV-related small HCC (pathologically proved, solitary tumour <5cm, or two/ tumours <5cm)
- Curative resection was defined as (1) the complete resection of all tumor nodules and the cut surface being free of cancer by histological examination; (2) no macroscopic cancerous thrombus was found in the portal vein (main trunk or two major branches), hepatic veins or bile duct, (3) no extrahepatic metastasis was found
- Evidence of a positive serum HBV profile but a negative test for anti-HCV antibody
- The major organ (heart, liver,lung and kidney) function was normal
Who cannot join
- History of cardiac disease
- Active clinically serious infection
- Known history of human immunodeficiency virus (HIV) infection
- Pregnant or breast-feeding patients
- Prior use of any systemic anti-cancer treatment for HCC, eg. Chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must at least 4 weeks prior randomization
- Any condition that is unstable or which could jeopardize the safety of the patient and his / her compliance in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Liver Cancer Institute and Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
S J Qiu, MD, +86-21-64037181, qiusj68@zshospital.com
About this study
Official title: Phase III Study of Thymopentin in Patients After Curative Resection of Small
The purpose of this study is to evaluate the clinical efficacy of thymopentin on the prevention of the recurrence and metastasis of small HCC after resection.
Read the detailed description
Hepatocellular carcinoma (HCC) is one of the most prevalent malignancies in China, and approximately 90% of the patients with HCC are also infected with hepatitis B virus (HBV).Chronic HBV infections are a leading cause of liver cirrhosis and hepatocellular carcinoma. Surgical resection provides a potentially curative outcome for patients who are indicated to this procedure; however, survival is far from satisfactory because of the high recurrence rate, which is approximately 38-65% during the first 5 years， even for small HCC resection , it is still as high as 43.5%，and contributed to the major cause of mortality. Several approaches have been reported to decrease the recurrence rate after curative resection of HCC, such as postoperative transcatheter arterial chemoembolization (TACE) , chemotherapy , cyclic retinoic acid , and adoptive immunotherapy . However, these approaches are either controversial or require further evaluation , a substantial need for novel treatments is required urgently.
Tumor-induced immuno-suppression leads to an imbalance within the immune system, which closely related to the HCC recurrence and metastasis after resection, and an effective response is needed to eliminate residual tumor cells after removal of the major tumor tissue by surgery. Immunomodulatory peptides, like thymopentin (TP5), may act as immunomodulatory agents in cancer chemotherapy. TP5 comprises the amino acids (Arg-Lys-Asp-Val-Tyr) and represents residues 32-36 of the nuclear protein thymopoietin (TP) . A multitude of in vivo studies have shown efficacy of TP5 treatment in the therapy of various diseases including neoplastic, immune deficiency, autoimmune, and recurrent viral diseases etc. It rectifies imbalances in the immune system without observable side effects, even at very high doses. Furthermore, TP5 is able to significantly inhibit proliferation and induce apoptosis in some type of cancer lines.
Thus TP5 can not only act as an immunomodulatory factor in cancer chemotherapy or anti-HBV therapy, but also has potential as a chemotherapeutic agent in human cancer therapy
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Thymopentin
- Keywords
- Hepatocellular Carcinoma, Thymopentin, Recurrence, Resection
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThymopentinDrug
subcutaneously or intramuscular inject at the dosage of 10 mg every second day (twice a week) for consecutive 3 months.
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
Measured: three year
Secondary outcomes (1)
overall survival
Measured: three year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2007 (estimated)
- Study startFeb 2007
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- Jia Fan, MD, Study director, Liver Cancer Institute and Zhongshan Hospital, Fudan University, 200032, Shanghai, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460681
- Sponsor's protocol ID
- ZSH-LCI-FJ-0001
- Status last verified
- Oct 2007
- First submitted
- 13 Apr 2007
- Last updated
- 31 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Thymopentin in Patients After Curative Resection of Small
- ClinicalTrials.gov ID
- NCT00460681
- Acronym / sponsor ID
- ZSH-LCI-FJ-0001
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Thymopentin, Recurrence, Resection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Feb 2007
- Study completion
- Feb 2012 (estimated)
- First posted
- 16 Apr 2007 (estimated)
- 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 purpose of this study is to evaluate the clinical efficacy of thymopentin on the prevention of the recurrence and metastasis of small HCC after resection.
Detailed description
Hepatocellular carcinoma (HCC) is one of the most prevalent malignancies in China, and approximately 90% of the patients with HCC are also infected with hepatitis B virus (HBV).Chronic HBV infections are a leading cause of liver cirrhosis and hepatocellular carcinoma. Surgical resection provides a potentially curative outcome for patients who are indicated to this procedure; however, survival is far from satisfactory because of the high recurrence rate, which is approximately 38-65% during the first 5 years， even for small HCC resection , it is still as high as 43.5%，and contributed to the major cause of mortality. Several approaches have been reported to decrease the recurrence rate after curative resection of HCC, such as postoperative transcatheter arterial chemoembolization (TACE) , chemotherapy , cyclic retinoic acid , and adoptive immunotherapy . However, these approaches are either controversial or require further evaluation , a substantial need for novel treatments is required urgently.
Tumor-induced immuno-suppression leads to an imbalance within the immune system, which closely related to the HCC recurrence and metastasis after resection, and an effective response is needed to eliminate residual tumor cells after removal of the major tumor tissue by surgery. Immunomodulatory peptides, like thymopentin (TP5), may act as immunomodulatory agents in cancer chemotherapy. TP5 comprises the amino acids (Arg-Lys-Asp-Val-Tyr) and represents residues 32-36 of the nuclear protein thymopoietin (TP) . A multitude of in vivo studies have shown efficacy of TP5 treatment in the therapy of various diseases including neoplastic, immune deficiency, autoimmune, and recurrent viral diseases etc. It rectifies imbalances in the immune system without observable side effects, even at very high doses. Furthermore, TP5 is able to significantly inhibit proliferation and induce apoptosis in some type of cancer lines.
Thus TP5 can not only act as an immunomodulatory factor in cancer chemotherapy or anti-HBV therapy, but also has potential as a chemotherapeutic agent in human cancer therapy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who received curative resection of HBV-related small HCC (pathologically proved, solitary tumour <5cm, or two/ tumours <5cm)
- Curative resection was defined as (1) the complete resection of all tumor nodules and the cut surface being free of cancer by histological examination; (2) no macroscopic cancerous thrombus was found in the portal vein (main trunk or two major branches), hepatic veins or bile duct, (3) no extrahepatic metastasis was found
- Evidence of a positive serum HBV profile but a negative test for anti-HCV antibody
- The major organ (heart, liver,lung and kidney) function was normal
Key exclusion criteria (6 listed)
- History of cardiac disease
- Active clinically serious infection
- Known history of human immunodeficiency virus (HIV) infection
- Pregnant or breast-feeding patients
- Prior use of any systemic anti-cancer treatment for HCC, eg. Chemotherapy, immunotherapy or hormonal therapy (except that hormonal therapy for supportive care is permitted). Antiviral treatment is allowed, however interferon therapy must at least 4 weeks prior randomization
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 |
|---|---|---|
| Thymopentinsubcutaneously or intramuscular inject at the dosage of 10 mg every second day (twice a week) for consecutive 3 months. | Drug | – |
Primary outcome
disease-free survival
Time frame: three year
1 secondary outcome
overall survival
Time frame: three year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2007.
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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.
Jia Fan, MD study director
Liver Cancer Institute and Zhongshan Hospital, Fudan University, 200032, Shanghai, China.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thymopentin in people with Hepatocellular Carcinoma, run by Fudan 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 4 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 31 Oct 2007. 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 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 S J Qiu, MD (+86-21-64037181, qiusj68@zshospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (time frame: three year). 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 31 Oct 2007.