NPCNPCNCT01744587
Epstein-Barr Virus Reactivation and the Effect of EGCG on Virus Reactivation in Remission Patients
A study testing Epigallocatechin Gallate (EGCG) in people with NPC, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
Trial summary
The purpose of this study is to investigate the EBV reactivation rate in post-radiation and remission NPC patients, evaluate the safety and tolerance of EGCG and analyze the observational correlation between EBV reactivation and clinical outcome. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- NPC
- What is being tested?
- Epigallocatechin Gallate (EGCG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 353 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2013to 16 May 2023
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven NPC.
- 2010 AJCC stage II-IVB.
- Age ≧ 20 years old.
- Performance status of ECOG ≦ 2.
- Finished RT ≧66 Gy within 6 months (± induction/concurrent/adjuvant chemotherapy).
- Clinical complete remission by re-staging work-ups within 3 months before entry.
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- Plasma EBV DNA = 0 copy/ml within 4 weeks before entry.
- Adequate liver, renal, and bone marrow function:Serum total bilirubin level ≦ 2.5 mg/dl. Serum creatinine ≦ 1.6 mg/dl. WBC ≧ 3,000/ul. Platelet count ≧ 100,000/ul.
- No intake of EGCG or similar dietary supplements.
- Signed informed consent.
- No further anti-cancer treatment.
Who cannot join
- Occurrence of locoregional recurrence or distant metastasis.
- Inadequate RT or finishing RT > 6 months.
- Not complete remission by re-staging work-ups within 3 months before entry.
- Plasma EBV DNA > 0 copy/ml within 4 weeks before entry.
- Intake of EGCG or similar dietary supplements during recent 3 months.
- Severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taiwan Cooperative Oncology Group, National Health Research Institutes
Zhunan, Miaoli, 350
About this study
Official title: Study of Epstein-Barr Virus Reactivation and the Effect of Dietary Supplement Epigallocatechin Gallate (EGCG) on Virus Reactivation in Remission Patients With Nasopharyngeal Carcinoma - A Randomized Trial
The purpose of this study is to investigate the EBV reactivation rate in post-radiation and remission NPC patients, evaluate the safety and tolerance of EGCG and analyze the observational correlation between EBV reactivation and clinical outcome.
Read the detailed description
Patients with pathologically proven NPC, stage II-IVB and finishing curative RT ≧70 Gy within 6 months (± induction/concurrent/adjuvant chemotherapy) will be candidates for this study. Before entry, 8 CC venous blood will be obtained for EBV DNA and antibody screen tests after patient's consent. Those who have undetectable plasma EBV DNA (0 copy/ml) and fulfilled with all inclusion and exclusion criteria will be registered.
Routine re-staging work-ups after RT should show no active lesion in nasopharynx, neck and distant organs. Re-staging survey should include nasopharyngoscope, pEBV DNA assay, CBC, platelet count, renal and liver function tests, CXR, abdominal sonography or CT scan, whole body bone scan, MRI or CT scan of the head and neck region.
Within one week after finishing registration, EGCG or placebo should be started. A blood sample before taking EGCG/placebo will be collected for antibodies test and pEBV DNA assay.
- Conditions
- NPC
- Being tested
- Epigallocatechin Gallate (EGCG), Placebo
- Keywords
- EBV, EGCG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epigallocatechin Gallate (EGCG)Other
Also called EGCHAC-purified EGCG 90% capsules
EGCG 600 mg per day will be provided to the test group.Four capsules will be taken daily (2# bid) by the test individuals.
PlaceboDietary supplement
Placebo qd (2# bid) for 3 years
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo qd (2# bid) for 3 years Receives: Dietary Supplement: Placebo |
| Epigallocatechin Gallate (EGCG) | Experimental | EGCG 600 mg qd (2# bid) for 3 years Receives: Other: Epigallocatechin Gallate (EGCG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EBV reactivation rates between EGCG and placebo group
Reactivation of EBV is defined as
1.Antibody against EBV VCA: The IgA antibody titers will be detected by a commercial EBV VCA ELISA kit (RE 562 71, Immuno-Biological Laboratories, Germany) Patient's serum with anti-EBV VCA greater than 10U/ml will be considered as reactivation of EBV.
Measured: every 3 months for the first 3 years and every 6 months thereafter for antibodies tests and pEBV DNA assay (total 5 years)
Secondary outcomes (1)
Correlation between EBV reactivation and OS/RFS
Observational analysis of the correlation between EBV reactivation and clinical outcome
Measured: q 3 months for first 3 years and q 6 months for the
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startApr 2013
- Primary completion16 May 2023
- Study completion16 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NPCStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Mackay Memorial Hospital, Taichung Veterans General Hospital, National Cheng-Kung University Hospital, Chang Gung Memorial Hospital, China Medical University Hospital, National Taiwan University Hospital
- Responsible party
- Sponsor
- Investigators
- Tsang Wu Liu, MD, Study director, Taiwan Cooperative Oncology Group, National Health Research InstitutesJin Ch Lin, MD PHD, Principal investigator, Taichung Veterans General HospitalJen Ya Chen, PHD, Principal investigator, National Institute of Cancer Research, National Health Research Institutes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744587
- Sponsor's protocol ID
- T2312
- Acronym
- NPC
- Status last verified
- Aug 2025
- First submitted
- 5 Dec 2012
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tsai HJ, Cheng SH, Yang SN, Tsou HH, Hsiao CF, Chang YF, Liu WS, Tsai JT, Hsieh CY, Tsai YC, Tsai MH, Ko JY, Hua CH, Ting LL, Lien MY, Wu YH, Tsai ST, Chen JY, Lin JC, Liu TW. A randomized trial to evaluate the effect of epigallocatechin gallate (EGCG) on EBV reactivation in patients with nasopharyngeal carcinoma in remission -the TCOG T2312 study. Eur J Cancer. 2026 Oct 1;248:117445. doi: 10.1016/j.ejca.2026.117445. Online ahead of print.
PubMed 42833136
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Epstein-Barr Virus Reactivation and the Effect of Dietary Supplement Epigallocatechin Gallate (EGCG) on Virus Reactivation in Remission Patients With Nasopharyngeal Carcinoma - A Randomized Trial
- ClinicalTrials.gov ID
- NCT01744587
- Acronym / sponsor ID
- NPC / T2312
- Conditions
- NPC
- Keywords
- EBV, EGCG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- Mackay Memorial Hospital, Taichung Veterans General Hospital, National Cheng-Kung University Hospital, Chang Gung Memorial Hospital, China Medical University Hospital, National Taiwan University Hospital
- Study start
- Apr 2013 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 6 Dec 2012 (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 investigate the EBV reactivation rate in post-radiation and remission NPC patients, evaluate the safety and tolerance of EGCG and analyze the observational correlation between EBV reactivation and clinical outcome.
Detailed description
Patients with pathologically proven NPC, stage II-IVB and finishing curative RT ≧70 Gy within 6 months (± induction/concurrent/adjuvant chemotherapy) will be candidates for this study. Before entry, 8 CC venous blood will be obtained for EBV DNA and antibody screen tests after patient's consent. Those who have undetectable plasma EBV DNA (0 copy/ml) and fulfilled with all inclusion and exclusion criteria will be registered.
Routine re-staging work-ups after RT should show no active lesion in nasopharynx, neck and distant organs. Re-staging survey should include nasopharyngoscope, pEBV DNA assay, CBC, platelet count, renal and liver function tests, CXR, abdominal sonography or CT scan, whole body bone scan, MRI or CT scan of the head and neck region.
Within one week after finishing registration, EGCG or placebo should be started. A blood sample before taking EGCG/placebo will be collected for antibodies test and pEBV DNA assay.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo qd (2# bid) for 3 years |
| Epigallocatechin Gallate (EGCG) | Experimental | Other: Epigallocatechin Gallate (EGCG)EGCG 600 mg qd (2# bid) for 3 years |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically proven NPC.
- 2010 AJCC stage II-IVB.
- Age ≧ 20 years old.
- Performance status of ECOG ≦ 2.
- Finished RT ≧66 Gy within 6 months (± induction/concurrent/adjuvant chemotherapy).
Key exclusion criteria (6 listed)
- Occurrence of locoregional recurrence or distant metastasis.
- Inadequate RT or finishing RT > 6 months.
- Not complete remission by re-staging work-ups within 3 months before entry.
- Plasma EBV DNA > 0 copy/ml within 4 weeks before entry.
- Intake of EGCG or similar dietary supplements during recent 3 months.
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 |
|---|---|---|
| Epigallocatechin Gallate (EGCG)Also: EGCHAC-purified EGCG 90% capsulesEGCG 600 mg per day will be provided to the test group.Four capsules will be taken daily (2# bid) by the test individuals. | Other | Epigallocatechin Gallate (EGCG) |
| PlaceboPlacebo qd (2# bid) for 3 years | Dietary supplement | Placebo |
Primary outcome
EBV reactivation rates between EGCG and placebo group
Time frame: every 3 months for the first 3 years and every 6 months thereafter for antibodies tests and pEBV DNA assay (total 5 years)
Reactivation of EBV is defined as 1.Antibody against EBV VCA: The IgA antibody titers will be detected by a commercial EBV VCA ELISA kit (RE 562 71, Immuno-Biological Laboratories, Germany) Patient's serum with anti-EBV VCA greater than 10U/ml will be considered as reactivation of EBV.
1 secondary outcome
Correlation between EBV reactivation and OS/RFS
Time frame: q 3 months for first 3 years and q 6 months for the
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Derived from this study: PubMed 42833136Tsai HJ, Cheng SH, Yang SN, Tsou HH, Hsiao CF, Chang YF, Liu WS, Tsai JT, Hsieh CY, Tsai YC, Tsai MH, Ko JY, Hua CH, Ting LL, Lien MY, Wu YH, Tsai ST, Chen JY, Lin JC, Liu TW. A randomized trial to evaluate the effect of epigallocatechin gallate (EGCG) on EBV reactivation in patients with nasopharyngeal carcinoma in remission -the TCOG T2312 study. Eur J Cancer. 2026 Oct 1;248:117445. doi: 10.1016/j.ejca.2026.117445. Online ahead of print.
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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.
Tsang Wu Liu, MD study director
Taiwan Cooperative Oncology Group, National Health Research Institutes
Jin Ch Lin, MD PHD principal investigator
Taichung Veterans General Hospital
Jen Ya Chen, PHD principal investigator
National Institute of Cancer Research, National Health Research Institutes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epigallocatechin Gallate (EGCG) in people with NPC, run by National Health Research Institutes, Taiwan at 1 site in Taiwan.
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 11 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: finished, as of the sponsor's last update on 15 Aug 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 Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EBV reactivation rates between EGCG and placebo group (time frame: every 3 months for the first 3 years and every 6 months thereafter for antibodies tests and pEBV DNA assay (total 5 years)). 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 NCT01744587, which also lists 1 linked publication.
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 15 Aug 2025.