A Phase 3 interventional study of Best Practice and Entecavir in Hepatitis B Infection and Malignant Solid Neoplasm, sponsored by SWOG Cancer Research Network. Terminated at 193 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-20.
Sponsored by SWOG Cancer Research Network · Phase 3, Interventional, and Prevention
This phase III trial studies the effect of hepatitis B antiviral (anti-HBV) therapy in preventing liver complications in patients with chronic or past hepatitis B virus (HBV) who are receiving anti-cancer therapy for solid tumors. People with chronic or past HBV who are undergoing therapy for cancer are at an increased risk for changes in the liver which could be minor or severe. Anti-HBV therapy acts against infections caused by HBV and may help reduce the chance that HBV gets worse or comes back in patients receiving anti-cancer therapy for solid tumors.
Co-Primary Objectives
Secondary Objectives
Translational Objectives
OUTLINE: Patients are recruited in two cohorts (Cohort 1: chronic HBV infection, Cohort 2: past HBV infection), with each cohort randomized equally to one of two potential treatment arms.
Chronic HBV Infection (Cohort 1) Arms:
Arm 1: Patients receive tenofovir alafenamide (TAF) orally (PO) once daily (QD) or tenofovir disoproxil fumarate (TDF) PO QD or entecavir PO QD immediately or within 42 days after initial dose of chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.
Arm 2: Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.
Past HBV infection (Cohort 2) Arms:
Arm 3: Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.
Arm 4: Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for HBV may be used.
(Cohort 1: Arm 2 and Cohort 2: Arm 3 follow the same treatment plan, but are considered part of separate parallel studies and are therefore identified as separate arms.)
Patients are followed for 24 months: every 4 weeks from randomization to week 24, then every 8 weeks thereafter up to week 104.
1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
This study's enrollment of 4 is below the median of 147 across 756 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →SWOG Cancer Research Network is the lead sponsor of 339 studies on the registry; 37 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion 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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
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.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
\[Cohort 1\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD immediately or within 42 days after initial dose of chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.
Drug: Entecavir · Drug: Tenofovir Alafenamide · Drug: Tenofovir Disoproxil Fumarate
\[Cohort 1\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.
Drug: Entecavir · Drug: Tenofovir Alafenamide · Drug: Tenofovir Disoproxil Fumarate
\[Cohort 2\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.
Drug: Entecavir · Drug: Tenofovir Alafenamide · Drug: Tenofovir Disoproxil Fumarate
\[Cohort 2\] Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for treatment of HBV may be utilized.
Other: Best Practice · Drug: Entecavir · Drug: Tenofovir Alafenamide · Drug: Tenofovir Disoproxil Fumarate
Receive best practice
Also known as: standard of care, standard therapy
Given PO
Also known as: Baraclude, BMS-200475-01, ETV, SQ-34676, SQ34676
Given PO
Also known as: GS 7340, GS-7340, TFV Alafenamide
Given PO
Also known as: PMPA Prodrug, TDF, Tenofovir DF, Viread
Number of Participants With Adverse Liver Outcome
Adverse liver outcome: Defined as liver-related death or liver failure (ascites, hepatic encephalopathy or impaired hepatic synthetic function defined as total bilirubin ≥ 5 mg/dL or INR ≥ 2.0) not due to disease progression in the liver. Assessment of the primary endpoint will be made by sites and subsequently adjudicated by the research oversight team by blinded review.
Time frame: From randomization to 24 months
Number of Participants With Hepatitis B Virus (HBV) Reactivation
HBV reactivation is is defined as one of the following: * ≥ 2 log (100-fold) increase in HBV DNA compared to baseline in patients with detectable HBV DNA at baseline, or * HBV DNA ≥ 3 log (1,000) IU/mL in a patient with previously undetectable HBV DNA, or * HBV DNA ≥ 4 log (10,000) IU/mL if baseline HBV DNA not available, or * HBsAg seroreversion (HBsAg- to HBsAg+) in a patient previously HBsAg-.
Time frame: From randomization up to 24 months
Number of Participants With Hepatitis B Virus (HBV) Flare
Hepatitis flare is defined as ALT \> 3 x baseline and \>100 U/L.
Time frame: From randomization to 24 months
Combined Endpoint of Adverse Liver Outcomes and HBV Reactivation, Number of Participants
Adverse liver outcome: Defined as liver-related death or liver failure (ascites, hepatic encephalopathy or impaired hepatic synthetic function defined as total bilirubin ≥ 5 mg/dL or INR ≥ 2.0) not due to disease progression in the liver. Assessment of the primary endpoint will be made by sites and subsequently adjudicated by the research oversight team by blinded review. HBV reactivation is defined as one of the following: * ≥ 2 log (100-fold) increase in HBV DNA compared to baseline in patients with detectable HBV DNA at baseline, or * HBV DNA ≥ 3 log (1,000) IU/mL in a patient with previously undetectable HBV DNA, or * HBV DNA ≥ 4 log (10,000) IU/mL if baseline HBV DNA not available, or * HBsAg seroreversion (HBsAg- to HBsAg+) in a patient previously HBsAg-. The combined endpoint of adverse liver outcomes and HBV reactivation is the occurrence of either adverse liver outcome or HBV reactivation as defined above.
Time frame: From randomization to 24 months
| Milestone | Arm 1 (TAF, TDF, Entecavir: Prophylactic) | Arm 2 (TAF, TDF, Entecavir: Upon Indication) | Arm 3 (TAF, TDF, Entecavir: Upon Indication) | Arm 4 (Anti-Viral Therapy: Usual Care) |
|---|---|---|---|---|
| Started | 0 | 0 | 2 | 2 |
| Received anti-hbv treatment per assignment | 0 | 0 | 0 | 1 |
| Completed | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 2 | 2 |
| Withdrew: Study terminated | 0 | 0 | 2 | 2 |
Adverse liver outcome: Defined as liver-related death or liver failure (ascites, hepatic encephalopathy or impaired hepatic synthetic function defined as total bilirubin ≥ 5 mg/dL or INR ≥ 2.0) not due to disease progression in the liver. Assessment of the primary endpoint will be made by sites and subsequently adjudicated by the research oversight team by blinded review.
| Participants | Arm 1 (TAF, TDF, Entecavir: Prophylactic) | Arm 2 (TAF, TDF, Entecavir: Upon Indication) | Arm 3 (TAF, TDF, Entecavir: Upon Indication) | Arm 4 (Anti-Viral Therapy: Usual Care) |
|---|---|---|---|---|
| Number of Participants With Adverse Liver Outcome | — | — | 0 | 0 |
HBV reactivation is is defined as one of the following: * ≥ 2 log (100-fold) increase in HBV DNA compared to baseline in patients with detectable HBV DNA at baseline, or * HBV DNA ≥ 3 log (1,000) IU/mL in a patient with previously undetectable HBV DNA, or * HBV DNA ≥ 4 log (10,000) IU/mL if baseline HBV DNA not available, or * HBsAg seroreversion (HBsAg- to HBsAg+) in a patient previously HBsAg-.
| Participants | Arm 1 (TAF, TDF, Entecavir: Prophylactic) | Arm 2 (TAF, TDF, Entecavir: Upon Indication) | Arm 3 (TAF, TDF, Entecavir: Upon Indication) | Arm 4 (Anti-Viral Therapy: Usual Care) |
|---|---|---|---|---|
| Number of Participants With Hepatitis B Virus (HBV) Reactivation | — | — | 0 | 0 |
Hepatitis flare is defined as ALT \> 3 x baseline and \>100 U/L.
| Participants | Arm 1 (TAF, TDF, Entecavir: Prophylactic) | Arm 2 (TAF, TDF, Entecavir: Upon Indication) | Arm 3 (TAF, TDF, Entecavir: Upon Indication) | Arm 4 (Anti-Viral Therapy: Usual Care) |
|---|---|---|---|---|
| Number of Participants With Hepatitis B Virus (HBV) Flare | — | — | 0 | 0 |
Adverse liver outcome: Defined as liver-related death or liver failure (ascites, hepatic encephalopathy or impaired hepatic synthetic function defined as total bilirubin ≥ 5 mg/dL or INR ≥ 2.0) not due to disease progression in the liver. Assessment of the primary endpoint will be made by sites and subsequently adjudicated by the research oversight team by blinded review. HBV reactivation is defined as one of the following: * ≥ 2 log (100-fold) increase in HBV DNA compared to baseline in patients with detectable HBV DNA at baseline, or * HBV DNA ≥ 3 log (1,000) IU/mL in a patient with previously undetectable HBV DNA, or * HBV DNA ≥ 4 log (10,000) IU/mL if baseline HBV DNA not available, or * HBsAg seroreversion (HBsAg- to HBsAg+) in a patient previously HBsAg-. The combined endpoint of adverse liver outcomes and HBV reactivation is the occurrence of either adverse liver outcome or HBV reactivation as defined above.
| Participants | Arm 1 (TAF, TDF, Entecavir: Prophylactic) | Arm 2 (TAF, TDF, Entecavir: Upon Indication) | Arm 3 (TAF, TDF, Entecavir: Upon Indication) | Arm 4 (Anti-Viral Therapy: Usual Care) |
|---|---|---|---|---|
| Combined Endpoint of Adverse Liver Outcomes and HBV Reactivation, Number of Participants | — | — | 0 | 0 |
Collected over Adverse event data were collected over 2 years, but, with the exception of study endpoints, adverse events were only collected after participants began treatment with anti-HBV therapy.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 (TAF, TDF, Entecavir: Prophylactic) | — | — | — |
| Arm 2 (TAF, TDF, Entecavir: Upon Indication) | — | — | — |
| Arm 3 (TAF, TDF, Entecavir: Upon Indication) | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Arm 4 (Anti-Viral Therapy: Usual Care) | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
There were no participants registered to the Chronic HBV infection cohort \[Cohort 1, Arms 1 and 2\]
| Age, Continuous(years) | Arm 1 (TAF, TDF, Entecavir: Prophylactic) | Arm 2 (TAF, TDF, Entecavir: Upon Indication) | Arm 3 (TAF, TDF, Entecavir: Upon Indication) | Arm 4 (Anti-Viral Therapy: Usual Care) | Total |
|---|---|---|---|---|---|
| Median | — | — | 47.5 (45.5 to 49.5) | 75.4 (64.4 to 86.3) | 62.45 (45.5 to 86.3) |
| Sex: Female, Male(Participants) | Arm 1 (TAF, TDF, Entecavir: Prophylactic) | Arm 2 (TAF, TDF, Entecavir: Upon Indication) | Arm 3 (TAF, TDF, Entecavir: Upon Indication) | Arm 4 (Anti-Viral Therapy: Usual Care) | Total |
|---|---|---|---|---|---|
| Female | — | — | 2 | 1 | 3 |
| Male | — | — | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Arm 1 (TAF, TDF, Entecavir: Prophylactic) | Arm 2 (TAF, TDF, Entecavir: Upon Indication) | Arm 3 (TAF, TDF, Entecavir: Upon Indication) | Arm 4 (Anti-Viral Therapy: Usual Care) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | — | — | 0 | 0 | 0 |
| Not Hispanic or Latino | — | — | 2 | 2 | 4 |
| Unknown or Not Reported | — | — | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm 1 (TAF, TDF, Entecavir: Prophylactic) | Arm 2 (TAF, TDF, Entecavir: Upon Indication) | Arm 3 (TAF, TDF, Entecavir: Upon Indication) | Arm 4 (Anti-Viral Therapy: Usual Care) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | — | — | 0 | 0 | 0 |
| Asian | — | — | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | — | — | 0 | 1 | 1 |
| Black or African American | — | — | 0 | 0 | 0 |
| White | — | — | 0 | 0 | 0 |
| More than one race | — | — | 0 | 0 | 0 |
| Unknown or Not Reported | — | — | 0 | 0 | 0 |
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