Colorectal NeoplasmsPhase 2NCT02777814
Prophylactic or Preemptive Entecavir in Patients With Colorectal Cancer Who Are Inactive Hepatitis B Carriers
A Phase 2 study testing Entecavir in people with Colorectal Neoplasms, run by Sun Yat-sen University at 1 site in China.
Trial summary
There has been no report on whether the patients with colorectal cancer who are also inactive Hepatitis B Carriers should receive Prophylactic Use or preemptive Use of an Anti-viral Drug Entecavir. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Entecavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2015to Nov 2019
- Phase
- Phase 2
- 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 with age between 18 and 75
- Patient with histology-proven colorectal adenocarcinoma.
- Patients with Eastern Cooperative Oncology Group performance status (ECOG) of 0-1
- Patients planned for at least 4 cycles of cytotoxic chemotherapy (either as part of curative therapy or as palliative therapy)
- Patients with at least 6 months' life expectancy from date of recruitment
- Patients with positive Hepatitis B Surface-antigen (HBsAg)
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- Patients with normal liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase alkaline (AST), phosphatase (ALP), gamma glutamyl-transpeptidase (GGT), and bilirubin
- Patients with negative HBV-DNA
- Patients with no known history of radiological \&/or histological diagnosis of chronic active hepatitis or cirrhosis of any cause, or history of prior hepatitis B reactivation, or prior chronic therapy for HBV within 6 months
- Patients with no evidence of autoimmune hepatitis, hepatitis C or D virus infection, HIV infection or radiological evidence of liver metastasis
- adequate bone marrow, hepatic, and renal function within 14 days before recruitment
- patients who sign the informed consent
- Patients with good compliance during chemotherapy and follow-ups
Who cannot join
- Patients planned for radiation or radionuclide therapy
- Pregnant female patients
- Patients with a history of psychiatric drugs abuse and can't quit or with a mental disorder
- Patients with immunodeficiency, other congenital or acquired immunodeficiency, or transplantation history
- According to the investigators' judgment, patients with concomitant disease that seriously harms patients' safety or the completion of study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Feng Wang
About this study
Official title: An Open, Randomized Controlled Clinical Trial to Compare the Prophylactic Use or Preemptive Use of an Anti-viral Drug Entecavir in Patients With Colorectal Cancer Who Are Inactive Hepatitis B Carriers
There has been no report on whether the patients with colorectal cancer who are also inactive Hepatitis B Carriers should receive Prophylactic Use or preemptive Use of an Anti-viral Drug Entecavir. This open, randomized controlled clinical trial aims to compare the impact of the prophylactic use or preemptive use of an anti-viral drug Entecavir on the outcomes of patients with colorectal cancer who are also inactive hepatitis B carriers during chemotherapy and the subsequent follow-ups.
- Conditions
- Colorectal Neoplasms
- Being tested
- Entecavir
- Keywords
- colorectal cancer, Entecavir, Hepatitis B Carrier
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntecavirDrug
Also called Entecavir Dispersible Tablets
anti hepatitis B virus
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic Entecavir | Experimental | Entecavir is prophylactically used from the time of chemotherapy initiation at the dose of 0.5 mg p.o daily Receives: Drug: Entecavir |
| Preemptive Entecavir | Active comparator | Entecavir is preemptively used from the time that hepatitis B virus DNA copies are more than 100 IU/ml at the dose of 0.5 mg p.o daily Receives: Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hepatitis B virus associated hepatitis
Hepatitis is defined as a 3-fold or greater increase in the serum ALT level that exceeded the reference range (>58U/L) or an absolute increase in the level of ALT of greater than 100 U/L compared with the baseline level
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Incidence of hepatitis B virus reactivation
Reactivation of HBV is defined as a 10-fold or greater increase in the HBV DNA level or an absolute increase of 10^5 copies/mL or greater compared with the baseline value.
Measured: through study completion, an average of 1 year
Interruption of chemotherapy due to hepatitis
Chemotherapy disruption is defined as either premature termination or a delay of at least 7 days between chemotherapy cycles.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study start1 May 2015
- Primary completionOct 2018
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruihua Xu, Sun Yat-sen University
- Investigators
- Rui-hua Xu, M.D. Ph.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777814
- Sponsor's protocol ID
- CRC-HBV
- Status last verified
- Jan 2019
- First submitted
- 1 Apr 2016
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Di Bisceglie AM, Lok AS, Martin P, Terrault N, Perrillo RP, Hoofnagle JH. Recent US Food and Drug Administration warnings on hepatitis B reactivation with immune-suppressing and anticancer drugs: just the tip of the iceberg? Hepatology. 2015 Feb;61(2):703-11. doi: 10.1002/hep.27609.
PubMed 25412906Huang H, Li X, Zhu J, Ye S, Zhang H, Wang W, Wu X, Peng J, Xu B, Lin Y, Cao Y, Li H, Lin S, Liu Q, Lin T. Entecavir vs lamivudine for prevention of hepatitis B virus reactivation among patients with untreated diffuse large B-cell lymphoma receiving R-CHOP chemotherapy: a randomized clinical trial. JAMA. 2014 Dec 17;312(23):2521-30. doi: 10.1001/jama.2014.15704.
PubMed 25514302Perrillo RP, Gish R, Falck-Ytter YT. American Gastroenterological Association Institute technical review on prevention and treatment of hepatitis B virus reactivation during immunosuppressive drug therapy. Gastroenterology. 2015 Jan;148(1):221-244.e3. doi: 10.1053/j.gastro.2014.10.038. Epub 2014 Oct 31. No abstract available.
PubMed 25447852
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomized Controlled Clinical Trial to Compare the Prophylactic Use or Preemptive Use of an Anti-viral Drug Entecavir in Patients With Colorectal Cancer Who Are Inactive Hepatitis B Carriers
- ClinicalTrials.gov ID
- NCT02777814
- Acronym / sponsor ID
- CRC-HBV
- Conditions
- Colorectal Neoplasms
- Keywords
- colorectal cancer, Entecavir, Hepatitis B Carrier
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Nov 2019 (estimated)
- First posted
- 19 May 2016 (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.
There has been no report on whether the patients with colorectal cancer who are also inactive Hepatitis B Carriers should receive Prophylactic Use or preemptive Use of an Anti-viral Drug Entecavir. This open, randomized controlled clinical trial aims to compare the impact of the prophylactic use or preemptive use of an anti-viral drug Entecavir on the outcomes of patients with colorectal cancer who are also inactive hepatitis B carriers during chemotherapy and the subsequent follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic Entecavir | Experimental | Drug: EntecavirEntecavir is prophylactically used from the time of chemotherapy initiation at the dose of 0.5 mg p.o daily |
| Preemptive Entecavir | Active comparator | Drug: EntecavirEntecavir is preemptively used from the time that hepatitis B virus DNA copies are more than 100 IU/ml at the dose of 0.5 mg p.o daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with age between 18 and 75
- Patient with histology-proven colorectal adenocarcinoma.
- Patients with Eastern Cooperative Oncology Group performance status (ECOG) of 0-1
- Patients planned for at least 4 cycles of cytotoxic chemotherapy (either as part of curative therapy or as palliative therapy)
- Patients with at least 6 months' life expectancy from date of recruitment
Key exclusion criteria (5 listed)
- Patients planned for radiation or radionuclide therapy
- Pregnant female patients
- Patients with a history of psychiatric drugs abuse and can't quit or with a mental disorder
- Patients with immunodeficiency, other congenital or acquired immunodeficiency, or transplantation history
- According to the investigators' judgment, patients with concomitant disease that seriously harms patients' safety or the completion of study.
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 |
|---|---|---|
| EntecavirAlso: Entecavir Dispersible Tabletsanti hepatitis B virus | Drug | Preemptive Entecavir, Prophylactic Entecavir |
Primary outcome
Incidence of hepatitis B virus associated hepatitis
Time frame: through study completion, an average of 1 year
Hepatitis is defined as a 3-fold or greater increase in the serum ALT level that exceeded the reference range (>58U/L) or an absolute increase in the level of ALT of greater than 100 U/L compared with the baseline level
2 secondary outcomes
Incidence of hepatitis B virus reactivation
Time frame: through study completion, an average of 1 year
Interruption of chemotherapy due to hepatitis
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Background: PubMed 25412906Di Bisceglie AM, Lok AS, Martin P, Terrault N, Perrillo RP, Hoofnagle JH. Recent US Food and Drug Administration warnings on hepatitis B reactivation with immune-suppressing and anticancer drugs: just the tip of the iceberg? Hepatology. 2015 Feb;61(2):703-11. doi: 10.1002/hep.27609.
- Results publication: PubMed 25514302Huang H, Li X, Zhu J, Ye S, Zhang H, Wang W, Wu X, Peng J, Xu B, Lin Y, Cao Y, Li H, Lin S, Liu Q, Lin T. Entecavir vs lamivudine for prevention of hepatitis B virus reactivation among patients with untreated diffuse large B-cell lymphoma receiving R-CHOP chemotherapy: a randomized clinical trial. JAMA. 2014 Dec 17;312(23):2521-30. doi: 10.1001/jama.2014.15704.
- Results publication: PubMed 25447852Perrillo RP, Gish R, Falck-Ytter YT. American Gastroenterological Association Institute technical review on prevention and treatment of hepatitis B virus reactivation during immunosuppressive drug therapy. Gastroenterology. 2015 Jan;148(1):221-244.e3. doi: 10.1053/j.gastro.2014.10.038. Epub 2014 Oct 31. No abstract available.
- 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.
Rui-hua Xu, M.D. Ph.D. principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Entecavir in people with Colorectal Neoplasms, 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 13 inclusion and 5 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 Jan 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Rui-hua Xu, M.D. Ph.D. (+86-20-87343295, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hepatitis B virus associated hepatitis (time frame: through study completion, an average of 1 year). 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 NCT02777814, which also lists 3 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 Jan 2019.