Nasopharyngeal Cancinoma (NPC)Phase 2NCT07138989

EBV Lytic Reactivation Therapy Combined With PD-1 Antibody in Recurrent/Metastatic Nasopharyngeal Carcinoma

A Phase 2 study testing Valganciclovir Hydrochloride Tablets and gemcitabine, cisplatin, and PD-1 antibody in people with Nasopharyngeal Cancinoma (NPC), run by Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Nasopharyngeal Cancinoma (NPC)
What is being tested?: Valganciclovir Hydrochloride Tablets and gemcitabine, cisplatin, and PD-1 antibody
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteChina
Study dates: 19 Aug 2025to 18 Aug 2031
Phase: Phase 2
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 must voluntarily participate and provide written informed consent.
Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma (NPC) at enrollment, with positive EBERs by pathological immunohistochemistry.
Metastatic NPC includes both newly diagnosed metastatic disease and metastatic disease after failure of first-line therapy, as well as recurrent NPC not amenable to local regional treatment, with confirmed metastatic or recurrent disease and no prior treatment after diagnosis.
Age ≥ 18 years and ≤ 75 years, of any sex.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Expected survival time ≥ 3 months.

Show all 9Show fewer

Baseline plasma EBV DNA > 0 copies/mL.
Adequate organ function confirmed by the following criteria (no blood component transfusions or use of hematopoietic growth factors within 2 weeks prior to study treatment initiation):
Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; platelet count ≥ 100 × 10^9/L; hemoglobin ≥ 90 g/L. Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or calculated creatinine clearance (CrCl) ≥ 60 mL/min . Total bilirubin (TBil) ≤ 1.5 × ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (for patients with liver metastases, TBil ≤ 3 × ULN; AST and ALT ≤ 5 × ULN). Serum albumin ≥ 28 g/L.

Who cannot join

History of severe hypersensitivity reactions to other monoclonal antibodies or to any component of PD-1 inhibitors.
Receipt of radiotherapy, biological therapy (e.g., tumor vaccines, cytokines, or growth factors), or other immunotherapy (excluding PD-1 and PD-L1 inhibitors), or any other anti-tumor treatment within 28 days or 5 half-lives prior to the first dose of study drug, whichever is shorter.
Prior treatment targeting Epstein-Barr virus (EBV) specifically.
History of any Grade ≥3 bleeding event, as defined by CTCAE v5.0, within 4 weeks prior to screening, or patients deemed at high risk of bleeding by the investigator.
Presence of necrotic lesions within 4 weeks prior to screening, with high risk of major hemorrhage as judged by the investigator.
Known congenital or acquired immunodeficiency (e.g., HIV-positive individuals).

Show all 18Show fewer

Requirement for systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive agents within 14 days prior to initiation of study treatment.
History of active tuberculosis (TB). Suspected active TB must be excluded through chest X-ray, sputum examination, and clinical assessment of signs and symptoms.
Patients with HBV DNA ≥1000 copies/mL. Patients with positive hepatitis C antibody results may only be enrolled if polymerase chain reaction (PCR) testing confirms HCV RNA negativity.
Pregnant or breastfeeding women, or women of childbearing potential not using effective contraception.
History of other malignancies, except for adequately treated basal cell carcinoma or carcinoma in situ of the cervix.
Uncontrolled cardiovascular conditions, including but not limited to: Heart failure with NYHA classification ≥2; Unstable angina; Myocardial infarction within the past year; Supraventricular or ventricular arrhythmias requiring treatment or intervention.
Significant impairment of cardiac, hepatic, pulmonary, renal, or bone marrow function.
Severe and uncontrolled medical illnesses or infections.
Concurrent participation in another clinical trial or use of another investigational agent.
Refusal or inability to sign informed consent.
Any other contraindications to study treatment as determined by the investigator.
Individuals with personality disorders or psychiatric conditions, and those lacking or having limited legal capacity to provide consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Qiu-Yan Chen, MD,PhD contact

86-20-87343380

chenqy@sysucc.org.cn

China1 site

Sun Yat-sen Universitty Cancer Center
Guangzhou, Guangdong, 510060
Hai-Qiang Mai, MD,PhD, +862087343643, maihq@sysucc.org.cn

Other trials in China

About this study

Official title: Efficacy and Safety of EBV Lytic Reactivation Therapy Combined With PD-1 Antibody in Recurrent/Metastatic Nasopharyngeal Carcinoma: a Single-center, Single-arm Phase II Trial

Nearly all undifferentiated nasopharyngeal carcinoma (NPC) are associated with the Epstein-Barr Virus (EBV), which typically remains in a latent, non-immunogenic state within tumor cells. By combining EBV lytic induction strategy with standard chemo-immunotherapy, this study aims to create a synergistic anti-tumor effect and improve clinical outcomes for patients with recurrent/metastatic NPC (r/m NPC). This is a phase II, single-center, single-arm clinical trial designed to evaluate the efficacy and safety of a novel combination therapy in patients with r/m EBV-positive NPC.

Read the detailed description

Rationale: Epstein-Barr virus (EBV) is clonally present in nearly all undifferentiated nasopharyngeal carcinoma (NPC) tumor cells, particularly in endemic regions. In most cases, EBV remains in a latent state, expressing only a limited set of non-immunogenic proteins, which facilitates immune evasion by tumor cells. Chemotherapeutic agents such as gemcitabine and cisplatin can induce the EBV lytic cycle, activate valganciclovir hydrochloride, thereby enabling the selective killing of EBV-infected tumor cells. This strategy may act synergistically with immunotherapy. Early-phase clinical studies have demonstrated the safety and potential efficacy of this approach; however, larger-scale studies are required to confirm these findings.

Study Objectives: The primary objectives of this clinical trial are: 1.To assess the objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), duration of response (DoR), and overall survival (OS) in patients receiving chemotherapy combined with valganciclovir hydrochloride and PD-1 antibody. 2.To evaluate the safety profile, including acute and chronic toxicities.

Study Design and Treatment Regimen: Patients with histologically confirmed EBV-positive, recurrent or metastatic NPC will be enrolled. Patients will receive 4 to 6 cycles of gemcitabine, cisplatin, and PD-1 antibody, with oral administration of valganciclovir hydrochloride tablets during the first 3 cycles. Following completion of the 4 to 6 cycles, patients will continue PD-1 antibody maintenance therapy for up to two years or until disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of informed consent, or death.

Conditions: Nasopharyngeal Cancinoma (NPC)
Being tested: Valganciclovir Hydrochloride Tablets, gemcitabine, cisplatin, and PD-1 antibody
Keywords: nasopharyngeal carcinoma, Epstein-Barr virus, immunotherapy
Medical subject headings: Nasopharyngeal Carcinoma, Epstein-Barr Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Valganciclovir Hydrochloride TabletsDrug
Valganciclovir hydrochloride tablets will be administered at 900 mg twice daily from day 1 to day 14, followed by 450 mg twice daily from day 15 to day 20, for a total of 3 cycles.
gemcitabine, cisplatin, and PD-1 antibodyDrug
Gemcitabine 1000 mg/m² will be administered intravenously on days 1 and 8; cisplatin 80 mg/m² intravenously on day 1; and PD-1 antibody intravenously on day 1. Each cycle is 21 days in duration, and treatment will be administered for a total of 4 to 6 cycles.
Following completion of the 4 to 6 cycles, patients will continue PD-1 antibody maintenance therapy (every 3 weeks) for up to two years or until disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of informed consent, or death.

Study groups in NCT07138989
Study group	Role	What they receive
EBV Lytic Reactivation Therapy	Experimental	Patients will receive 4 to 6 cycles of gemcitabine, cisplatin, and PD-1 antibody, with oral administration of valganciclovir hydrochloride tablets during the first 3 cycles. Following completion of 4 to 6 cycles, patients will continue with maintenance therapy using PD-1 antibody. Receives: Drug: Valganciclovir Hydrochloride Tablets; Drug: gemcitabine, cisplatin, and PD-1 antibody

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Response Rate, ORR
Objective Response Rate (ORR) is defined as either a confirmed CR or a PR, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 from the National Cancer Institute (NCI).
Measured: From enrollment to the end of treatment. Up to 2 approximately years.

Secondary outcomes (5)

Disease Control Rate，DCR
Disease Control Rate (DCR) is defined as the proportion of patients who achieve tumor response classified as partial response (PR), complete response (CR), or stable disease (SD) according to recognized response evaluation criteria-such as RECIST version 1.1.
Measured: From enrollment to the end of treatment. Up to 2 approximately years.
Progression-free Survival, PFS
Defined as the time from registration to documented disease progression or non-cancer-specific death.
Measured: 1 years; 2 years; 5 years;
Duration of Response, DoR
Defined as the median length of time from the initial documentation of a tumor response (either complete response [CR] or partial response [PR]) to disease progression or death from any cause.
Measured: From enrollment to disease progression. Up to 2 approximately years.
Overall Survival, OS
Defined as the time from registration to death from any cause.
Measured: 1 years; 2 years; 5 years
Incidence rate of acute and late adverse events (AEs)
Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs.
Measured: From enrollment to the end of follow-ups. Up to 2 approximately years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Aug 202518 Aug 2031

First posted24 Aug 2025
Study start19 Aug 2025 (estimated)
Primary completion18 Aug 2026 (estimated)
Study completion18 Aug 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Nasopharyngeal Cancinoma (NPC)Studies 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07138989
Sponsor's protocol ID: 2025-FXY-184
Status last verified: Aug 2025
First submitted: 11 Aug 2025
Last updated: 24 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Complete de-identified patient data set will be submitted to the Research Data Deposit (RDD) public platform (http://www.researchdata.org.cn) and available from the principal investigators upon reasonable request.

Publications

Ghosh SK, Perrine SP, Williams RM, Faller DV. Histone deacetylase inhibitors are potent inducers of gene expression in latent EBV and sensitize lymphoma cells to nucleoside antiviral agents. Blood. 2012 Jan 26;119(4):1008-17. doi: 10.1182/blood-2011-06-362434. Epub 2011 Dec 7.
PubMed 22160379
Perrine SP, Hermine O, Small T, Suarez F, O'Reilly R, Boulad F, Fingeroth J, Askin M, Levy A, Mentzer SJ, Di Nicola M, Gianni AM, Klein C, Horwitz S, Faller DV. A phase 1/2 trial of arginine butyrate and ganciclovir in patients with Epstein-Barr virus-associated lymphoid malignancies. Blood. 2007 Mar 15;109(6):2571-8. doi: 10.1182/blood-2006-01-024703. Epub 2006 Nov 21.
PubMed 17119113
Wu M, Hau PM, Li L, Tsang CM, Yang Y, Taghbalout A, Chung GT, Hui SY, Tang WC, Jillette N, Zhu JJ, Lee HHY, Kong EL, Chan MSA, Chan JYK, Ma BBY, Chen MR, Lee C, To KF, Cheng AW, Lo KW. Synthetic BZLF1-targeted transcriptional activator for efficient lytic induction therapy against EBV-associated epithelial cancers. Nat Commun. 2024 May 3;15(1):3729. doi: 10.1038/s41467-024-48031-8.
PubMed 38702330
Mai HQ, Chen QY, Chen D, Hu C, Yang K, Wen J, Li J, Shi Y, Jin F, Xu R, Pan J, Qu S, Li P, Hu C, Liu YC, Jiang Y, He X, Wang HM, Lim WT, Liao W, He X, Chen X, Wang S, Yuan X, Li Q, Lin X, Jing S, Chen Y, Lu Y, Hsieh CY, Yang MH, Yen CJ, Samol J, Luo X, Wang X, Tang X, Feng H, Yao S, Keegan P, Xu RH. Toripalimab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: The JUPITER-02 Randomized Clinical Trial. JAMA. 2023 Nov 28;330(20):1961-1970. doi: 10.1001/jama.2023.20181.
PubMed 38015220

Interested in taking part?

Qiu-Yan Chen, MD,PhD

86-20-87343380

chenqy@sysucc.org.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruitingPhase 2
Risk-Adapted Anlotinib and PD-L1 for Locoregionally Advanced Nasopharyngeal Carcinoma
Nasopharyngeal Cancinoma (NPC)
Not yet recruitingPhase 2
Dynamic Plasma EBV DNA-Guided Risk-Adapted Treatment With Becotatug Vedotin (MRG003) Plus PD-1 Blockade in Locoregionally Advanced Nasopharyngeal Carcinoma
Nasopharyngeal Cancinoma (NPC), Nasopharyngeal Cancer
RecruitingPhase 3
Prophylactic Nanocrystalline Megestrol Acetate Versus Placebo for Chemoradiotherapy-Related Anorexia in Nasopharyngeal Carcinoma
Nasopharyngeal Cancinoma (NPC)
RecruitingPhase 1
Intratumoral Injection of Recombinant Human Endostatin Adenovirus (EDS01) for the Treatment of Recurrent or Metastatic Head and Neck Tumors
Head & Neck Cancer, Nasopharyngeal Cancinoma (NPC)
Not yet recruitingPhase 2
Platinum-Free Regimen in Nasopharyngeal Carcinoma
Nasopharyngeal Cancinoma (NPC)

All Nasopharyngeal Cancinoma (NPC) trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of EBV Lytic Reactivation Therapy Combined With PD-1 Antibody in Recurrent/Metastatic Nasopharyngeal Carcinoma: a Single-center, Single-arm Phase II Trial
ClinicalTrials.gov ID: NCT07138989
Acronym / sponsor ID: 2025-FXY-184
Conditions: Nasopharyngeal Cancinoma (NPC)
Keywords: nasopharyngeal carcinoma, Epstein-Barr virus, immunotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 10 participants (estimated)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: 19 Aug 2025 (estimated)
Primary completion: 18 Aug 2026 (estimated)
Study completion: 18 Aug 2031 (estimated)
First posted: 24 Aug 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
EBV Lytic Reactivation Therapy	Experimental	Drug: Valganciclovir Hydrochloride Tablets, Drug: gemcitabine, cisplatin, and PD-1 antibodyPatients will receive 4 to 6 cycles of gemcitabine, cisplatin, and PD-1 antibody, with oral administration of valganciclovir hydrochloride tablets during the first 3 cycles. Following completion of 4 to 6 cycles, patients will continue with maintenance therapy using PD-1 antibody.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Patients must voluntarily participate and provide written informed consent.
Histologically or cytologically confirmed recurrent or metastatic nasopharyngeal carcinoma (NPC) at enrollment, with positive EBERs by pathological immunohistochemistry.
Metastatic NPC includes both newly diagnosed metastatic disease and metastatic disease after failure of first-line therapy, as well as recurrent NPC not amenable to local regional treatment, with confirmed metastatic or recurrent disease and no prior treatment after diagnosis.
Age ≥ 18 years and ≤ 75 years, of any sex.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Key exclusion criteria (18 listed)

History of severe hypersensitivity reactions to other monoclonal antibodies or to any component of PD-1 inhibitors.
Receipt of radiotherapy, biological therapy (e.g., tumor vaccines, cytokines, or growth factors), or other immunotherapy (excluding PD-1 and PD-L1 inhibitors), or any other anti-tumor treatment within 28 days or 5 half-lives prior to the first dose of study drug, whichever is shorter.
Prior treatment targeting Epstein-Barr virus (EBV) specifically.
History of any Grade ≥3 bleeding event, as defined by CTCAE v5.0, within 4 weeks prior to screening, or patients deemed at high risk of bleeding by the investigator.
Presence of necrotic lesions within 4 weeks prior to screening, with high risk of major hemorrhage as judged by the investigator.

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
Valganciclovir Hydrochloride TabletsValganciclovir hydrochloride tablets will be administered at 900 mg twice daily from day 1 to day 14, followed by 450 mg twice daily from day 15 to day 20, for a total of 3 cycles.	Drug	EBV Lytic Reactivation Therapy
gemcitabine, cisplatin, and PD-1 antibodyGemcitabine 1000 mg/m² will be administered intravenously on days 1 and 8; cisplatin 80 mg/m² intravenously on day 1; and PD-1 antibody intravenously on day 1. Each cycle is 21 days in duration, and treatment will be administered for a total of 4 to 6 cycles. Following completion of the 4 to 6 cycles, patients will continue PD-1 antibody maintenance therapy (every 3 weeks) for up to two years or until disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of informed consent, or death.	Drug	EBV Lytic Reactivation Therapy

Primary outcome

Objective Response Rate, ORR
Time frame: From enrollment to the end of treatment. Up to 2 approximately years.
Objective Response Rate (ORR) is defined as either a confirmed CR or a PR, as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 from the National Cancer Institute (NCI).

5 secondary outcomes

Disease Control Rate，DCR
Time frame: From enrollment to the end of treatment. Up to 2 approximately years.
Progression-free Survival, PFS
Time frame: 1 years; 2 years; 5 years;
Duration of Response, DoR
Time frame: From enrollment to disease progression. Up to 2 approximately years.
Overall Survival, OS
Time frame: 1 years; 2 years; 5 years
Incidence rate of acute and late adverse events (AEs)
Time frame: From enrollment to the end of follow-ups. Up to 2 approximately years.

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 24 Aug 2025.
Background: PubMed 22160379Ghosh SK, Perrine SP, Williams RM, Faller DV. Histone deacetylase inhibitors are potent inducers of gene expression in latent EBV and sensitize lymphoma cells to nucleoside antiviral agents. Blood. 2012 Jan 26;119(4):1008-17. doi: 10.1182/blood-2011-06-362434. Epub 2011 Dec 7.
Background: PubMed 17119113Perrine SP, Hermine O, Small T, Suarez F, O'Reilly R, Boulad F, Fingeroth J, Askin M, Levy A, Mentzer SJ, Di Nicola M, Gianni AM, Klein C, Horwitz S, Faller DV. A phase 1/2 trial of arginine butyrate and ganciclovir in patients with Epstein-Barr virus-associated lymphoid malignancies. Blood. 2007 Mar 15;109(6):2571-8. doi: 10.1182/blood-2006-01-024703. Epub 2006 Nov 21.
Background: PubMed 38702330Wu M, Hau PM, Li L, Tsang CM, Yang Y, Taghbalout A, Chung GT, Hui SY, Tang WC, Jillette N, Zhu JJ, Lee HHY, Kong EL, Chan MSA, Chan JYK, Ma BBY, Chen MR, Lee C, To KF, Cheng AW, Lo KW. Synthetic BZLF1-targeted transcriptional activator for efficient lytic induction therapy against EBV-associated epithelial cancers. Nat Commun. 2024 May 3;15(1):3729. doi: 10.1038/s41467-024-48031-8.
Background: PubMed 38015220Mai HQ, Chen QY, Chen D, Hu C, Yang K, Wen J, Li J, Shi Y, Jin F, Xu R, Pan J, Qu S, Li P, Hu C, Liu YC, Jiang Y, He X, Wang HM, Lim WT, Liao W, He X, Chen X, Wang S, Yuan X, Li Q, Lin X, Jing S, Chen Y, Lu Y, Hsieh CY, Yang MH, Yen CJ, Samol J, Luo X, Wang X, Tang X, Feng H, Yao S, Keegan P, Xu RH. Toripalimab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: The JUPITER-02 Randomized Clinical Trial. JAMA. 2023 Nov 28;330(20):1961-1970. doi: 10.1001/jama.2023.20181.
Individual participant dataSharing planned: No. Complete de-identified patient data set will be submitted to the Research Data Deposit (RDD) public platform (http://www.researchdata.org.cn) and available from the principal investigators upon reasonable request.

Related trials for Nasopharyngeal Cancinoma (NPC)

Not yet recruitingPhase 2
Risk-Adapted Anlotinib and PD-L1 for Locoregionally Advanced Nasopharyngeal Carcinoma
Nasopharyngeal Cancinoma (NPC)
Not yet recruitingPhase 2
Dynamic Plasma EBV DNA-Guided Risk-Adapted Treatment With Becotatug Vedotin (MRG003) Plus PD-1 Blockade in Locoregionally Advanced Nasopharyngeal Carcinoma
Nasopharyngeal Cancinoma (NPC), Nasopharyngeal Cancer
RecruitingPhase 3
Prophylactic Nanocrystalline Megestrol Acetate Versus Placebo for Chemoradiotherapy-Related Anorexia in Nasopharyngeal Carcinoma
Nasopharyngeal Cancinoma (NPC)
RecruitingPhase 1
Intratumoral Injection of Recombinant Human Endostatin Adenovirus (EDS01) for the Treatment of Recurrent or Metastatic Head and Neck Tumors
Head & Neck Cancer, Nasopharyngeal Cancinoma (NPC)
Not yet recruitingPhase 2
Platinum-Free Regimen in Nasopharyngeal Carcinoma
Nasopharyngeal Cancinoma (NPC)

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.

Qiu-Yan Chen, MD,PhD contact

86-20-87343380

chenqy@sysucc.org.cn

Hai-Qiang Mai, MD,PhD principal investigator

Sun Yat-sen Universitty Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 18 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: opening soon, as of the sponsor's last update on 24 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Qiu-Yan Chen, MD,PhD (86-20-87343380, chenqy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate, ORR (time frame: From enrollment to the end of treatment. Up to 2 approximately 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 NCT07138989, which also lists 4 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 24 Aug 2025.