A Phase 3 interventional study of Entecavir in Gastrointestinal Cancers, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment
Among 109 studies in Gastrointestinal Neoplasms with a site in China — 43 open to participants now, 50 under way, 6 of them phase 3. Gastrointestinal Neoplasms · China.
Among the 109 studies in Gastrointestinal Neoplasms with a site in China, this one is the 40th largest by planned enrollment of the 87 interventional ones that give a count, is one of 7 that started in 2025, is one of 11 in phase 3, reaches primary completion later than 28 of the 49 other live ones, and was the 92nd registered.
696 studies on the registry are indexed under Gastrointestinal Neoplasms; 210 are open to participants now.
Browse Gastrointestinal Neoplasms studies →43 of the 109 studies in Gastrointestinal Neoplasms with a site in China are open now. Recruiting first, the newest first:
Xijing Hospital · Sites in China
Ages 45–74 · Healthy volunteers
Hunan Cancer Hospital · Sites in China
Ages 45–74 · Healthy volunteers
Changhai Hospital · Sites in China
Ages 18+
Peking University Cancer Hospital & Institute · Sites in China
Ages 18+
Beijing GoBroad Hospital · Sites in China
Ages 18–70
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 160 Gastrointestinal Neoplasms studies recruiting now, 122 (76%) set no upper age limit and 18 (11%) stop at 75 or younger; 8 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
109 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 27 · Phase 2 26 · Phase 3 12 · Phase 4 4
First in 2005; this study’s year is marked. 7 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 136 is above the median of 74 across 495 interventional studies indexed under Gastrointestinal Neoplasms.
Median enrollment 120 across the 87 interventional studies, 500 across the 22 observational. Of the 29 that completed or were terminated, 6 (21%) have results posted.
This tab as a report to print or save as PDF → With an account.
29 of 109 have an industry lead sponsor. The 10 most frequent:
Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 618 are open to participants now.
Sun Yat-sen University has 4 studies filed under Gastrointestinal Neoplasms — fewer than ten, so there is no comparison to draw.
15 of the studies in Gastrointestinal Neoplasms with a site in China that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03303495Phase 3Sun Yat-sen UniversityA Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC | 2026-12-31 |
| NCT06966232Phase 3Sun Yat-sen UniversityProphylactic or Preemptive Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers | 2027-05-15 |
| NCT05252078Jiangxi Provincial Cancer HospitalAnlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients | 2026-11 |
| NCT06881043The First Hospital of Jilin UniversityThe Safety and Efficacy of Robotic Assisted Surgery Using Vessel Sealer Extend in Locally Advanced Gastric Cancer | 2026-12-01 |
| NCT05489237IDRX, Inc., a wholly owned subsidiary of GSK, LLCFirst-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors | 2027-03-10 |
Add all 15 to your calendar (.ics) → With an account.
Among the 109 studies in Gastrointestinal Neoplasms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 .
Drug: Entecavir
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.
Drug: Entecavir
anti hepatitis B virus
Also known as: Entecavir Dispersible Tablets
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).
Time frame: through study completion, an average of 1 year
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
Time frame: 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.
Time frame: 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 .
Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of 1 year
HBV related death
HBV related death is defined as mortality directly attributable to HBV reactivation
Time frame: through study completion, an average of 1 year
Plan to share: Undecided
Start is estimated for May 2025; primary completion for May 2027, 24 months later.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Entecavir