Gastrointestinal CancersPhase 3NCT06966232
Prophylactic or Preemptive Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers
A Phase 3 study testing Entecavir in people with Gastrointestinal Cancers, run by Sun Yat-sen University at 1 site in China.
Trial summary
There has been no report on whether the patients with gastrointestinal cancer who are also inactive hepatitis B carriers should receive prophylactic use or preemptive use of an anti-viral drug entecavir during anti-tumor therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Cancers
- 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
- 136 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2025to 20 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 locally advanced unresectable or metastatic gastrointestinal cancers (colorectal cancer, gastric cancer, esophageal cancer, hepatocellular carcinoma, pancreatic cancer, and cholangiocarcinoma)
- Planned to receive first-, second-, or third-line anti-tumor therapy (chemotherapy or PD-1/PD-L1 monoclonal antibody immunotherapy)
- Patients with Eastern Cooperative Oncology Group performance status (ECOG) of 0-2
- Patients planned for at least 4 cycles of chemotherapy or immunotherapy
- Patients with at least 6 months' life expectancy from date of recruitment
Show all 12Show fewer
- Patients with chronic or past HBV infection (HBsAg-positive or HBcAb-positive), and hepatitis B is inactive
- Patients with normal liver function tests including alanine aminotransferase (ALT), aspartate aminotransferase alkaline (AST), and bilirubin
- Patients with negative HBV-DNA
- Adequate major organ function (laboratory tests 14 days before randomization meeting requirements for anti-tumor therapy)
- Patients who sign the informed consent
- Patients with good compliance during chemotherapy and follow-ups.
Who cannot join
- History of liver cirrhosis
- Prior HBV reactivation
- Received anti-HBV therapy for chronic hepatitis B within 6 months before enrollment
- Active co-infection with other hepatitis viruses
- HIV infection
- Autoimmune hepatitis
Show all 12Show fewer
- History of hepatic radiotherapy
- Scheduled hepatic radiotherapy or radioisotope therapy
- Pregnant or lactating women
- 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Feng Wang, +86-20-87342479, wangfeng@sysucc.org.cn
About this study
Official title: An Open, Multicentre, Phase 3, Randomized Controlled Clinical Trial to Compare the Prophylactic Use or Preemptive Use of an Anti-viral Drug Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers
There has been no report on whether the patients with gastrointestinal cancer who are also inactive hepatitis B carriers should receive prophylactic use or preemptive use of an anti-viral drug entecavir during anti-tumor therapy. This open, multicentre, phase 3, 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 gastrointestinal cancer who are also inactive hepatitis B carriers during chemotherapy or immunotherapy and the subsequent follow-ups, including two cohorts of chemotherapy and immunotherapy.
Read the detailed description
Patients with gastrointestinal cancer who are also inactive hepatitis B carriers are enrolled and randomized into two groups as following. Patients in experimental group are treated with entecavir prophylactically in the dose of 0.5mg p.o. every day from the initiation of chemotherapy or immunotherapy till 6 months after the end of chemotherapy or immunotherapy. Patients in active comparator group are only treated with entecavir in the dose of 0.5mg p.o. every day from the time that the DNA copies of hepatitis B virus become positive till 6 months after the end of chemotherapy or immunotherapy.
- Conditions
- Gastrointestinal Cancers
- Being tested
- Entecavir
- Keywords
- Gastrointestinal Cancers, Entecavir, Hepatitis B Carrier, Chemotherapy, Immunotherapy
- Medical subject headings
- Gastrointestinal 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 or immunotherapy initiation at the dose of 0.5 mg p.o daily till 6 months after the end of chemotherapy or immunotherapy . Receives: Drug: Entecavir |
| Preemptive Entecavir | Active comparator | Entecavir is preemptively used from the time that hepatitis B virus DNA copies become positive at the dose of 0.5 mg p.o daily till 6 months after the end of chemotherapy or immunotherapy. Receives: Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hepatitis B virus reactivation
HBV reactivation is defined as (1) an increase in HBV-DNA levels by ≥2 log10 (100-fold) compared to baseline or conversion from negative serum HBV-DNA to positive HBV-DNA; (2) if baseline HBV-DNA was undetectable, achieving HBV-DNA levels ≥3 log10 (1,000 IU/mL); or (3) if baseline levels were unknown or unavailable, reaching HBV-DNA levels ≥4 log10 (10,000 IU/mL).
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Hepatitis
Hepatitis is defined as a 3-fold or greater increase in the serum ALT level that exceeded the reference range 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
Hepatitis B virus associated hepatitis
Hepatitis B virus associated hepatitis is defined as hepatitis B virus (HBV) reactivation occurring prior to or concurrent with hepatitis during or following chemotherapy/immunotherapy , in the absence of clinical or laboratory evidence of acute infection by other hepatitis viruses or systemic diseases.
Measured: through study completion, an average of 1 year
Interruption of chemotherapy/immunotherapy due to hepatitis
Chemotherapy/immunotherapy disruption due to hepatitis is defined as either premature termination or a delay of at least 7 days between therapy cycles due to hepatitis .
Measured: through study completion, an average of 1 year
Severe HBV associated hepatitis
Severe HBV associated hepatitis is defined as grade 3 or higher HBV associated hepatitis according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: through study completion, an average of 1 year
HBV associated acute liver failure
HBV associated acute liver failure, also termed HBV associated fulminant hepatic failure , is defined as acute hepatic decompensation linked to HBV reactivation or acute exacerbation of HBV infection. It manifests within days to weeks, leading to severe complications such as coagulopathy, hepatic encephalopathy, and multiorgan failure, with a high 28-day mortality rate . Delayed initiation of nucleotide analogues may contribute to rapid disease progression and poor prognosis.
Measured: through study completion, an average of 1 year
HBV related death
HBV related death is defined as mortality directly attributable to HBV reactivation
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 posted11 May 2025
- Study start15 May 2025 (estimated)
- Primary completion15 May 2027 (estimated)
- Study completion20 May 2027 (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 Gastrointestinal CancersStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui-hua Xu, MD, PhD, Sun Yat-sen University
- Investigators
- Xu Rui-hua, M.D. Ph.D, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966232
- Sponsor's protocol ID
- GIC-HBV
- Status last verified
- Apr 2025
- First submitted
- 2 May 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Perrillo 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 25447852Huang 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 25514302
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicentre, Phase 3, Randomized Controlled Clinical Trial to Compare the Prophylactic Use or Preemptive Use of an Anti-viral Drug Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers
- ClinicalTrials.gov ID
- NCT06966232
- Acronym / sponsor ID
- GIC-HBV
- Conditions
- Gastrointestinal Cancers
- Keywords
- Gastrointestinal Cancers, Entecavir, Hepatitis B Carrier, Chemotherapy, Immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 11 May 2025 (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.
There has been no report on whether the patients with gastrointestinal cancer who are also inactive hepatitis B carriers should receive prophylactic use or preemptive use of an anti-viral drug entecavir during anti-tumor therapy. This open, multicentre, phase 3, 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 gastrointestinal cancer who are also inactive hepatitis B carriers during chemotherapy or immunotherapy and the subsequent follow-ups, including two cohorts of chemotherapy and immunotherapy.
Detailed description
Patients with gastrointestinal cancer who are also inactive hepatitis B carriers are enrolled and randomized into two groups as following. Patients in experimental group are treated with entecavir prophylactically in the dose of 0.5mg p.o. every day from the initiation of chemotherapy or immunotherapy till 6 months after the end of chemotherapy or immunotherapy. Patients in active comparator group are only treated with entecavir in the dose of 0.5mg p.o. every day from the time that the DNA copies of hepatitis B virus become positive till 6 months after the end of chemotherapy or immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic Entecavir | Experimental | Drug: EntecavirEntecavir is prophylactically used from the time of chemotherapy or immunotherapy initiation at the dose of 0.5 mg p.o daily till 6 months after the end of chemotherapy or immunotherapy . |
| Preemptive Entecavir | Active comparator | Drug: EntecavirEntecavir is preemptively used from the time that hepatitis B virus DNA copies become positive at the dose of 0.5 mg p.o daily till 6 months after the end of chemotherapy or immunotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with age between 18 and 75
- Patient with histology-proven locally advanced unresectable or metastatic gastrointestinal cancers (colorectal cancer, gastric cancer, esophageal cancer, hepatocellular carcinoma, pancreatic cancer, and cholangiocarcinoma)
- Planned to receive first-, second-, or third-line anti-tumor therapy (chemotherapy or PD-1/PD-L1 monoclonal antibody immunotherapy)
- Patients with Eastern Cooperative Oncology Group performance status (ECOG) of 0-2
- Patients planned for at least 4 cycles of chemotherapy or immunotherapy
Key exclusion criteria (12 listed)
- History of liver cirrhosis
- Prior HBV reactivation
- Received anti-HBV therapy for chronic hepatitis B within 6 months before enrollment
- Active co-infection with other hepatitis viruses
- HIV infection
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
The incidence of hepatitis B virus reactivation
Time frame: through study completion, an average of 1 year
HBV reactivation is defined as (1) an increase in HBV-DNA levels by ≥2 log10 (100-fold) compared to baseline or conversion from negative serum HBV-DNA to positive HBV-DNA; (2) if baseline HBV-DNA was undetectable, achieving HBV-DNA levels ≥3 log10 (1,000 IU/mL); or (3) if baseline levels were unknown or unavailable, reaching HBV-DNA levels ≥4 log10 (10,000 IU/mL).
6 secondary outcomes
Hepatitis
Time frame: through study completion, an average of 1 year
Hepatitis B virus associated hepatitis
Time frame: through study completion, an average of 1 year
Interruption of chemotherapy/immunotherapy due to hepatitis
Time frame: through study completion, an average of 1 year
Severe HBV associated hepatitis
Time frame: through study completion, an average of 1 year
HBV associated acute liver failure
Time frame: through study completion, an average of 1 year
HBV related death
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- 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.
- 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.
- Individual participant dataSharing planned: Undecided
Related trials for Gastrointestinal Cancers
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
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.
Xu Rui-hua, M.D. Ph.D principal investigator
Sun Yat-Sen University Cancer Center
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 Entecavir in people with Gastrointestinal Cancers, 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 12 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 11 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xu Rui-hua, M.D. Ph.D (+86-20-87343008, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of hepatitis B virus reactivation (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 NCT06966232, 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 11 May 2025.