Gastric CancerNCT05431244
Pilot Study of Antiviral Treatment in Combination With Low-dose Gemcitabine in EBV-associated Gastric Cancer (EBVaGC)
A study testing Antiviral treatment in combination with low-dose gemcitabine in people with Gastric Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Epstein-Barr virus (EBV) is a double-stranded DNA human gamma herpes virus that establishes a persistent infection in over 90% of individuals. Most infections are self-limiting, but some cases are associated with the development of malignancies of lymphoid or epithelial origin. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Antiviral treatment in combination with low-dose gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2022to 1 Jul 2024
- 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
- Patients must be ≥20 years of age.
- Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after second-line therapy.
- The patient's tumor tissue must have the pre-defined characteristics as follows ; EBV+
- ECOG performance status 0-1
- Patients must have a life expectancy ≥ 4 months from proposed first dose date.
- The patient has measureable or evaluable disease as determined by standard computed tomography (CT) or magnetic resonance imaging (MRI) imaging. Examples of evaluable, nonmeasurable disease include gastric, peritoneal, or mesenteric thickening in areas of known disease, or peritoneal nodules that are too small to be considered measurable by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1)
- Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to administration of study treatment as defined below: WBC ≥ 3,500 cells/mm3 and ≤ 50,000 cells/mm3, ANC ≥ 1,500 cells/mm3, Hemoglobin ≥ 9 g/dL (transfusion allowed), Platelet count ≥ 100,000 /mm3; Total bilirubin ≤ 1.5 X ULN, AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN; Creatinine clearance ≥60 mL/min
- Provision of fully informed consent prior to any study specific procedures.
Who cannot join
- The patient has a history severe or unstable heart disease, e.g. coronary artery disease requiring increased dose of anti-anginal medication and/or coronary angioplasty (including stent placement) within 24 months ( congestive heart failure NYHA III or IV, unstable angina, history of myocardial infarction within the last 12 months, clinically significant arrhythmia)
- The patient is pregnant or breastfeeding.(For women with pregnancy potential, an effective method of contraception should be agreed.)
- The patient has ongoing Uncontrolled systemic diseases (diabetes, hypertension, hypothyroidism, infection, etc.)
- The patient has ongoing central nervous system malignancy. (except for lesions that have been completely removed or underwent anterior brain radiotherapy/gamma knife procedure)
- The patient has a history of allergic reactions to gemcitabine, Valganciclovir, aciclovir, valacyclovir ganciclovir
- Patients with interstitial pneumonia or pulmonary fibrosis with clinical symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Epstein-Barr virus (EBV) is a double-stranded DNA human gamma herpes virus that establishes a persistent infection in over 90% of individuals. Most infections are self-limiting, but some cases are associated with the development of malignancies of lymphoid or epithelial origin. EBV-associated gastric carcinomas (EBVaGC) make up about 9% of all stomach cancers.
The constant presence of the viral genome in EBVaGC suggests the applicability of novel EBV-targeted therapies.
Read more
The antiviral nucleoside drug, (val)ganciclovir (GCV), is effective only in the context of the viral lytic cycle in the presence of EBV-encoded thymidine kinase (TK)/ protein kinase (PK) expression. JM Lee et al. reported that gemcitabine was lytic inducer via activation of the ATM/p53 genotoxic stress pathway in EBVaGC and confirmed the efficacy of gemcitabine-GCV combination treatment.
So we planned this proof of concept trial to apply the antiviral agent in EBVaGC.
- Conditions
- Gastric Cancer
- Being tested
- Antiviral treatment in combination with low-dose gemcitabine
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiviral treatment in combination with low-dose gemcitabineDrug
-maximun 6 cycles Gemcitabine; 30mg/m2 or 100mg/m2 or 300mg/m2 D1,D8, D15 (Q 1 week,3 times, rest for 1 week, every 4 weeks ) 1,2 cycle Valganciclovir; 900mg D8~D28 (from 1 week after Gemcitabine iv started, qd, PO, 21days) 3~6cycle Valganciclovir; 900mg D1~D28 (from Gemcitabine start date, PO, 28days)
| Study group | Role | What they receive |
|---|---|---|
| Antiviral treatment in combination with low-dose gemcitabine | Other | For 1st \& 2nd cycle D1, 8, 15 Gemcitabine 30-300mg/m2 IV over 30 minutes D8-28 Valganciclovir 900mg qd Every 4 weeks
For 3rd ~ 6th cycle D1, 8, 15 Gemcitabine 30-300mg/m2 IV over 30 minutes D1-28 Valganciclovir 900mg qd Every 4 weeks Receives: Drug: Antiviral treatment in combination with low-dose gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Modified RECIST 1.1 criteria will be used to assess patient response to treatment by determining PFS and ORR. The modified RECIST 1.1 guidelines for measurable, non-measurable, target and non-target lesions and the objective tumour response criteria
Measured: up to 24months
Secondary outcomes (1)
Best Overall Response Rate (BOR)
Modified RECIST 1.1 criteria will be used to assess patient response to treatment by determining PFS and ORR. The modified RECIST 1.1 guidelines for measurable, non-measurable, target and non-target lesions and the objective tumour response criteria
Measured: up to 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Why it stopped: Research withdrawal before patient registration due to difficulty in continuing research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyun Lee, Samsung Medical Center
- Investigators
- Jeeyun Lee, M.D. Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431244
- Sponsor's protocol ID
- 2022-03-110
- Status last verified
- Oct 2022
- First submitted
- 13 Jun 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Antiviral Treatment in Combination With Low-dose Gemcitabine in EBV-associated Gastric Cancer (EBVaGC)
- ClinicalTrials.gov ID
- NCT05431244
- Acronym / sponsor ID
- 2022-03-110
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Research withdrawal before patient registration due to difficulty in continuing research
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 24 Jun 2022 (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.
Epstein-Barr virus (EBV) is a double-stranded DNA human gamma herpes virus that establishes a persistent infection in over 90% of individuals. Most infections are self-limiting, but some cases are associated with the development of malignancies of lymphoid or epithelial origin. EBV-associated gastric carcinomas (EBVaGC) make up about 9% of all stomach cancers.
The constant presence of the viral genome in EBVaGC suggests the applicability of novel EBV-targeted therapies.
The antiviral nucleoside drug, (val)ganciclovir (GCV), is effective only in the context of the viral lytic cycle in the presence of EBV-encoded thymidine kinase (TK)/ protein kinase (PK) expression. JM Lee et al. reported that gemcitabine was lytic inducer via activation of the ATM/p53 genotoxic stress pathway in EBVaGC and confirmed the efficacy of gemcitabine-GCV combination treatment.
So we planned this proof of concept trial to apply the antiviral agent in EBVaGC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antiviral treatment in combination with low-dose gemcitabine | Other | Drug: Antiviral treatment in combination with low-dose gemcitabineFor 1st \& 2nd cycle D1, 8, 15 Gemcitabine 30-300mg/m2 IV over 30 minutes D8-28 Valganciclovir 900mg qd Every 4 weeks For 3rd ~ 6th cycle D1, 8, 15 Gemcitabine 30-300mg/m2 IV over 30 minutes D1-28 Valganciclovir 900mg qd Every 4 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must be ≥20 years of age.
- Advanced gastric adenocarcinoma (including GEJ) that has progressed during or after second-line therapy.
- The patient's tumor tissue must have the pre-defined characteristics as follows ; EBV+
- ECOG performance status 0-1
- Patients must have a life expectancy ≥ 4 months from proposed first dose date.
Key exclusion criteria (6 listed)
- The patient has a history severe or unstable heart disease, e.g. coronary artery disease requiring increased dose of anti-anginal medication and/or coronary angioplasty (including stent placement) within 24 months ( congestive heart failure NYHA III or IV, unstable angina, history of myocardial infarction within the last 12 months, clinically significant arrhythmia)
- The patient is pregnant or breastfeeding.(For women with pregnancy potential, an effective method of contraception should be agreed.)
- The patient has ongoing Uncontrolled systemic diseases (diabetes, hypertension, hypothyroidism, infection, etc.)
- The patient has ongoing central nervous system malignancy. (except for lesions that have been completely removed or underwent anterior brain radiotherapy/gamma knife procedure)
- The patient has a history of allergic reactions to gemcitabine, Valganciclovir, aciclovir, valacyclovir ganciclovir
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 |
|---|---|---|
| Antiviral treatment in combination with low-dose gemcitabine-maximun 6 cycles Gemcitabine; 30mg/m2 or 100mg/m2 or 300mg/m2 D1,D8, D15 (Q 1 week,3 times, rest for 1 week, every 4 weeks ) 1,2 cycle Valganciclovir; 900mg D8~D28 (from 1 week after Gemcitabine iv started, qd, PO, 21days) 3~6cycle Valganciclovir; 900mg D1~D28 (from Gemcitabine start date, PO, 28days) | Drug | Antiviral treatment in combination with low-dose gemcitabine |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 24months
Modified RECIST 1.1 criteria will be used to assess patient response to treatment by determining PFS and ORR. The modified RECIST 1.1 guidelines for measurable, non-measurable, target and non-target lesions and the objective tumour response criteria
1 secondary outcome
Best Overall Response Rate (BOR)
Time frame: up to 24months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: No
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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.
Jeeyun Lee, M.D. Ph.D principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antiviral treatment in combination with low-dose gemcitabine in people with Gastric Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 8 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: withdrawn, as of the sponsor's last update on 1 Nov 2022. 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 South Korea. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Objective Response Rate (ORR) (time frame: up to 24months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2022.