Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

All Conditions

Infections

Symptoms and General Pathology

Rare Diseases

Nasopharyngeal Carcinoma

Carcinoma

Epstein-Barr Virus Infections

Virus Diseases

Communicable Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Cisplatin

Antimetabolites

Patients receive GP IC + IMRT concurrent with cisplatin chemotherapy + capecitabine AC. All patients will receive concurrent cisplatin (100 mg/m2) every 3 weeks, in a total of three cycles. All patients will receive low-dose metronomic capecitabine (650 mg/m2 bid, oral, d1-21, q3w) until disease progression, or intolerable toxicity or 6 months.

Patients receive GP IC + IMRT concurrent with cisplatin chemotherapy and anti-PD-1 therapy (sintilimab) + anti-PD-1 therapy (sintilimab) AC. All patients will receive concurrent cisplatin (100 mg/m2) and sintilimab (200 mg, IV drop 30-60 min) every 3 weeks in a total of three cycles. All patients will receive adjuvant anti-PD-1 therapy (sintilimab, 200 mg, IV drop 30-60 min, q3w) in a total of nine cycles until disease progression, or intolerable toxicity or 6 months.

Investigate whether capecitabine would be able to improve prognosis in patients at high risk groups

sintilimab

Investigate whether capecitabine would be able to improve prognosis in patients at intermediate risk groups

Ying Sun, M.D.

The investigators aim to investigate whether incorporating on-treatment EBV DNA surveillance for monitoring tumor responses to treatment and for guiding individuliased treatment adaptation can improve prognosis in nasopharyngeal carcinoma patient . For patients with detectable EBV DNA after one cycle of IC, which then drops to undetectable levels during the following IC cycles (intermediate responders/intermediate relapse risk), the investigators aim to investigate whether additional adjuvant metronomic capecitabine would benefit this subgroup. For patients with detectable EBV DNA after three cycles of IC or with EBV DNA bounce during the induction phase (insensitive to IC/high relapse risk), the investigators aim to investigate whether concurrent administration of anti-PD-1 therapy during the following treatment phases (including concurrent phase and adjuvant phase) can benefit this subgroup.

Nasopharyngeal carcinoma (NPC) is a unique head and neck cancer characterized by an extremely unbalanced global distribution. The highest incidence is observed in endemic regions, such as southern China and Southeast Asia, with an age-standardized rate of 3.0 per 100,000 in China to 0.4 per 100,000 in Caucasian populations. The fast progress of modern imaging and the application of intensity-modulated radiotherapy (IMRT) has improved the local control rate significantly. Distant metastasis has become the major cause of treatment failure.

The 2018 National Comprehensive Cancer Network (NCCN) guideline recommends concurrent chemoradiotherapy (CCRT) ± induction chemotherapy (IC)/adjuvant chemotherapy (AC) as the standard treatment for stage II-IVa disease (category 2A). While it is worth noting that there is extensive heterogeneity among patients with NPC, and even among patients with the same disease stage, the risk of relapse varies. More importantly, patients can have differing sensitivity to RT and chemotherapy. The abovementioned reasons result in over-treatment in some patients with relatively low relapse risk; intensive treatments lead to unnecessary toxicities, and greatly affect quality of life (QoL). On the other hand, the current treatment strategy may be not optimal for patients with high relapse risk or who are not sensitive to traditional chemoradiotherapy. Therefore, there is an urgent need for identifying and applying promising biomarkers, real-time monitoring of patient responses to treatment, predicting relapse risk, and guiding real-time treatment adaptation for individualized therapy.

The investigators aim to investigate whether incorporating on-treatment EBV DNA surveillance for monitoring tumor responses to treatment and for guiding individuliased treatment adaptation can improve prognosis in nasopharyngeal carcinoma patient . For patients with detectable EBV DNA after one cycle of IC, which then drops to undetectable levels during the following IC cycles (intermediate responders/intermediate relapse risk), the investigators aim to investigate whether additional adjuvant metronomic capecitabine would benefit this subgroup. For patients with detectable EBV DNA after three cycles of IC or with EBV DNA bounce during the induction phase (insensitive to IC/high relapse risk), the investigators aim to investigate whether concurrent administration of anti-PD-1 therapy during the following treatment phases (including concurrent phase and adjuvant phase) can benefit this subgroup.

EPstein-barr Virus DNA Response to Systemic Therapy for Treatment Adaptation in High Risk NPC (EP-STAR)

Epstein-Barr Virus DNA to Systemic Therapy for Treatment Adaptation in High Risk Nasopharyngeal Carcinoma (EP-STAR Trial) A Phase II, Multi-center, Biomarker-guided, Umbrella Trial

Currently, there is no plan to make individual participant data (IPD) available to other researchers.

FFS will be measured from the day of enrollment until treatment failure, death from any cause, or the last follow-up visit, whichever occurred first.

measured from the day of enrollment until death due to any cause, or the last follow-up visit.

measured from the day of enrollment until death until distant metastasis , or the last follow-up visit.

measured from the day of enrollment until death until local and/or regional recurrence, or the last follow-up visit.

The incidence of immune-related and other adverse events

Patient reported quality of life would be evaluated using the Quality of Life Questionnaire-Core 30 module (QLQ-C30)

Exploratory biomarker analysis that would be able to predict patient treatment benefits, for example PD-L1 expression, tumor mutational burden, etc.

National Cancer Centre, Singapore

Wuzhou Red Cross Hospital

First People's Hospital of Foshan

Sun Yat-sen University

Vice president

Gemcitabine

Carboplatin

Docetaxel

Fluorouracil

Arm 1: EBV DNA \<4000 copies/mL AND T3N0-2 or T4N0 (TNM AJCC/UICC 8th edition)

Arm 2: EBV DNA ≥4000 copies/mL OR N3 OR T4N+ (TNM AJCC/UICC 8th edition) AND EBV DNA undetectable after 2-3 cycles of induction chemotherapy (IC)

Arm 3: EBV DNA ≥4000 copies/mL OR N3 OR T4N+ (TNM AJCC/UICC 8th edition) AND EBV DNA detectable after 2-3 cycles of IC

Group 1: Recurrent/metastatic NPC, EBV DNA \<4000 copies/mL

Group 2: Recurrent/metastatic NPC, EBV DNA ≥4000 copies/mL

Concurrent chemoradiotherapy (CCRT) using cisplatin (100 mg/m2 IV) or carboplatin (AUC 5 IV) with radiotherapy +/- adjuvant chemotherapy (AC) with capecitabine (physician's choice of 650 mg/m2 bid or 1000 mg/m2 bid oral, d1-21, q3w)

Arm 1

IC using cisplatin (80 mg/m2 IV) or carboplatin (AUC 3-5 IV) in combination with gemcitabine (1000 mg/m2 d1,8) or 5-fluorouracil (1000 mg/m2 bolus IV d1-4) or docetaxel (75 mg/m2 IV), and CCRT

Arm 2

CCRT + metronomic capecitabine (650 mg/m2 bid oral, d1-21, q3w)

Arm 3

Combination chemotherapy (using cisplatin or carboplatin with gemcitabine, 5-fluorouracil or docetaxel) and consolidative RT to the nasopharynx and neck (if good response to chemotherapy) +/- metastasis-directed therapy (surgery, radiofrequency ablation or RT) +/- immune checkpoint blockade (ICB) or capecitabine

Group 1

Combination chemotherapy (using cisplatin or carboplatin with gemcitabine, 5-fluorouracil or docetaxel) with or without ICB +/- maintenance ICB or capecitabine

Group 2

Melvin Lee Kiang Chua, MBBS, FRCR, PhD, FAMS

This is a prospective platform study that will investigate the outcomes of patients with locoregionally-advanced nasopharyngeal carcinoma (LA-NPC) or recurrent-metastatic nasopharyngeal carcinoma (RM-NPC) who are assigned to treatment arms of different chemotherapy sequencing and intensity based on their pre- and on-treatment plasma EBV DNA results.

The primary objectives of this platform are: (1) to prospectively validate the prognostic potential of an EBV DNA-based risk-stratification strategy of patients with LA- and RM-NPC; and (2) to test if treatment individualization strategies based on pre- and on-treatment plasma EBV DNA will improve survival outcomes. Primary study end-point is 2-year disease-free survival (DFS).

Archival tissue, fresh tumour biopsy tissue, saliva and peripheral blood samples will be obtained for this study

Treatment Individualisation by EBV Stratification in Nasopharyngeal Carcinoma: a Prospective Observational Study

Blood samples will be collected at up to 7 timepoints - baseline, mid/post IC, mid CCRT, 1-2 weeks post-RT, 3 months post-RT/mid-adjuvant chemotherapy, at point of recurrence and post immune checkpoint blockade treatment (for recurrence, if any); fresh biopsy samples will be collected at baseline and at point of recurrence, if amenable for biopsy. Saliva samples will be collected at baseline and at point of recurrence.

Antibodies

Immunoglobulins

Immunoglobulin A

Immunologic Factors

first-degree relatives of nasopharyngeal carcinoma patients, aged 30-62 male

ELISA test of VCA-IgA，EBNA1-IgA，EA-IgA， Zta-IgA ，Rta-IgG and BNLF 2b in nasopharyngeal brushing and plasma

EBV antibodies test

quantitative polymerase chain reaction, CRISPR-associated protein 12a and target sequencing of EBV DNA in nasopharyngeal brushing and plasma

EBV DNA test

Ming-Yuan Chen, MD, PhD

Si-Yuan Chen, MD

Ming-Yuan Chen, MD,PhD

The investigators intend to compare Epstein-Barr virus antibody and Epstein-Barr virus DNA screening efficacy in first-degree relatives of nasopharyngeal carcinoma patients.

The investigators intend to test Epstein-Barr virus antibodies (Viral Capsid Antigen-immunoglobulin A， Epstein-Barr nuclear antigen 1-immunoglobulin A， early antigen-immunoglobulin A， Zta-immunoglobulin A， Rta-immunoglobulin G, Bnlf 2b) by ELISA and Epstein-Barr virus DNA by quantitative polymerase chain reaction, target sequencing and CRISPR-associated protein 12a in nasopharyngeal brushing and plasma of the same population at high-risk of nasopharyngeal carcinoma so as to determine the best method in nasopharyngeal carcinoma screening.

nasopharyngeal brushing and peripheral blood

Epstein-Barr Virus Antibody and Epstein-Barr Virus DNA for Nasopharyngeal Carcinoma Screening

Parallel Controlled Study of Epstein-Barr Virus Antibody and Epstein-Barr Virus DNA for Nasopharyngeal Carcinoma Screening in the High-risk Population

the ratio of subjects truly diagnosed as nasopharyngeal carcinoma to all those who had positive test results

the ratio of subjects truly diagnosed as negative (do not have nasopharyngeal carcinoma) to all those who had negative test results

the percentage of subjects who test positive to those who have nasopharyngeal carcinoma

the percentage of subjects who test negative to those who do not have nasopharyngeal carcinoma

the ratio of patients with stage I and stage II disease to all those who have nasopharyngeal carcinoma

the cost of detecting one nasopharyngeal carcinoma case

Zhongshan People's Hospital, Guangdong, China

Hunan Cancer Hospital

The Third Affiliated Hospital of Nanchang University

Yuebei People's Hospital

Xiangya Hospital of Central South University

Changsha Central Hospital

professor & chief physician

Adjuvant chemotherapy and then clinical follow-up and surveillance

Gemcitabine 1000 mg/m2 in 250 ml NS over 30 mins IV on Day 1 and 8 Cisplatin 40 mg/m2 in 1L NS over 2 h IV on Day 1 and 8 Cycle repeated every 3 weeks for total of 6 cycles

Adjuvant chemotherapy (gemcitabine and cisplatin)

Anthony TC Chan, MD, FRCP

Roger KC Ngan, FRCR

The purpose of this trial is to study the benefit of adjuvant chemotherapy using gemcitabine and cisplatin in high risk NPC patients with residual EBV DNA following primary radiotherapy with or without concurrent cisplatin.

* The standard treatment for nasopharynx cancer is a course of radiotherapy with or without concurrent chemotherapy. This will cure about 80% of patients. For the 20% who developed recurrence or metastases, the prognosis is poor.
* Elevated EBV-DNA in plasma at end of radiotherapy has been shown to predict disease recurrence and may be a marker of subclinical residual disease.
* This study aims to test whether adjuvant treatment with 6 cycles of a modern chemotherapy regimen (gemcitabine and cisplatin combination) can improve the survival of these high risk patients of nasopharynx cancer who have elevated EBV-DNA after completion of their radiotherapy.

A Trial of Adjuvant Chemotherapy in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy

A Multi-center Prospective Randomized Phase III Trial to Determine the Benefit of Adjuvant Chemotherapy Using Gemcitabine and Cisplatin in Nasopharyngeal Carcinoma Patients With Residual EBV DNA Following Primary Radiotherapy With or Without Concurrent Cisplatin

Overall survival is defined as the duration from the date of randomization to the date of death due to all causes or censored at the date of last follow-up

Hong Kong Nasopharyngeal Cancer Study Group Limited

Chinese University of Hong Kong

Consultant

Tislelizumab

Antineoplastic Agents, Immunological

EBV DNA ≥4000 copies/mL OR N3 OR T4N+ (TNM AJCC/UICC 8th edition) AND EBV DNA detectable after 3 cycles of IC.

CCRT: Radiotherapy will be delivered once daily, for 5 days per week, over 6 to 7 weeks. During RT, cisplatin will be administered either 100 mg/m2 3-weekly or 40 mg/m2 weekly, IV infusion (physician's choice).

Maintenance: Tislelizumab 200mg, day 1 per 3-week cycle, intravenous (IV) infusion and capecitabine 650 mg/m2, days 1-21 per 3-week cycle, bidaily, oral, for a total of 12 months (17 cycles).

CCRT with Maintenance Tislelizumab and Metronomic Capecitabine

Melvin LK CHUA, MBBS, FRCR, PhD, FAMS

Enya HW ONG

Patients with "high-risk" locoregionally-advanced nasopharyngeal carcinoma (LA-NPC), defined as AJCC/UICC 8th edition TNM-stage III-IVA and high Epstein-Barr virus (EBV) DNA viral load (≥4,000 copies/mL) will require induction chemotherapy (IC) prior to chemo-radiation (CCRT) as per standard treatment. Patients who persist to manifest DETECTABLE EBV DNA following 3 cycles of IC have a higher risk of relapse, and are typically recommended for a year of low-dose oral chemotherapy after CCRT.

RIBBON-LA-01 is a single-arm, open-label, phase 2 clinical trial of maintenance tislelizumab and metronomic capecitabine (metroCap) for 52 weeks after IC and CCRT, targeting this specific group of patients who have persistent detectable EBV DNA after IC. The main objective is to evaluate the efficacy of maintenance tislelizumab and metroCap in patients with DETECTABLE EBV DNA levels after 3 cycles of IC.

RIBBON-LA-01 is embedded in a modular platform trial concept (NCT05517135, https://clinicaltrials.gov/study/NCT05517135) that tests if EBV DNA-based risk stratification strategies for treatment individualization improves survival outcomes in LA-NPC. The overarching platform trial concept allocates patients with LA-NPC to treatment arms of different intensities by their plasma EBV DNA levels pre-treatment and post-IC.

RIBBON-LA-01 enrolls patients allocated to Arm 3 of the platform trial; these are patients with pre-treatment EBV DNA of \>4,000 copies/mL OR N2-3 or T4N+ NPC who were treated with upfront IC, but persist to manifest DETECTABLE EBV DNA levels following 3 cycles of IC. Patients on the trial will be assigned to CCRT followed by a 12-month course of maintenance tislelizumab and metroCap.

The primary endpoint of the study is two-year disease free survival, defined as the proportion of patients who are alive and free of disease relapse at the end of 2 years after the start of treatment.

Tislelizumab and Metronomic Capecitabine as Maintenance in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma

RIBBON-LA-01: Single-arm, Open-label, Phase 2 Trial of Tislelizumab and Metronomic Capecitabine as Maintenance Therapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma

The proportion of patients who are alive and free of disease relapse at the end of 2 years after the start of Induction Chemotherapy (IC) for patients.

Time from date of start of treatment (IC) to death from any cause, where patients lost to follow-up were censored at the date of last follow-up.

Time from date of start of treatment (IC) to documented distant metastasis or death from any cause, patients with locoregional relapse as a first event will be censored at date of locoregional relapse

Time from date start of treatment (IC) to documented locoregional relapse or death from any cause, patients with distant metastasis as a first event will be censored at the date of distant metastasis

BeiGene

Tan Tock Seng Hospital

Nimotuzumab

camrelizumab 200mg q3w 2 cycle combinted with the second and third cycle neoajuvant chemotherapy and camrelizumab 200mg q3w 8 cycle starting one month after concurrent chemo-radiotherapy.

nimotuzumab 200mg qw combined with the second and third cycle neoajuvant chemotherapy and nimotuzumab 200mg qw used during chemo-radiotherapy.

the second and third neoajuvant chemotherapy with GP regimen (gemcitabine 1g/m2 d1，8 plus cisplatin 75mg/m2 ) concurrent chemotherapy: single cisplatin (80mg/m2) for two cycle definitive radiotherapy for primay lesion and lymph node region.

Camrelizumab

neoadjuvant chemotherapy and CCRT

Chengrun Du

Hongmei Ying, M.D.

The goal of this multicenter randomized non-inferior study is to compare the additon of camrelizumab or nimotuzumab to neoadjuvant chemotherapy followed by concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma patients whose EBV DNA remained detectable after one cycle neoadjuvant chemotherapy using GP regimen. The main question it aims to answer is: whether the addition of carrilizumab or nituzumab improve the treatment outcomes in the relatively poor prognostic patients identified by the response of EBV DNA. Participants will be randomized to the combination of carrilizumab and standard treatment , the combination of nituzumab and standard treatment or the standard treatment alone if their EBV DNA didn't decrease to undetectable level post first cycle of neoadjuvant chemotherapy.

Intensified Treatments for Patients With Locally Advanced Nasopharyngeal Carcinoma With Detectable EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy

A Multicenter, Randomized Controlled Phase III Trial of Induction Plus Concurrent Chemoradiotherapy Plus Camrelizumab or Nimotuzumab Versus Induction Plus Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma With Detectable EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy

Defined from date of randomization to date of first documentation of progression or death due to any cause

Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.

Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
EPstein-barr Virus DNA Response to Systemic Therapy for Treatment Adaptation in High Risk NPC (EP-STAR)	NCT04072107	Nasopharyngeal ...	sintilimab Capecitabine	18 Years - 65 Years	Sun Yat-sen University
Treatment Individualisation by EBV Stratification in Nasopharyngeal Carcinoma: a Prospective Observational Study	NCT05517135	Nasopharyngeal ...	Arm 1 Arm 2 Arm 3 Group 1 Group 2	21 Years - 99 Years	National Cancer Centre, Singapore
Epstein-Barr Virus Antibody and Epstein-Barr Virus DNA for Nasopharyngeal Carcinoma Screening	NCT05447169	Nasopharyngeal ...	EBV antibodies ... EBV DNA test	30 Years - 62 Years	Sun Yat-sen University
A Trial of Adjuvant Chemotherapy in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy	NCT00370890	Nasopharyngeal ...	Adjuvant chemot...	18 Years -	Chinese University of Hong Kong
Tislelizumab and Metronomic Capecitabine as Maintenance in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma	NCT06093061	Nasopharyngeal ...	CCRT with Maint...	21 Years - 99 Years	National Cancer Centre, Singapore
Treatment Individualisation by EBV Stratification in Nasopharyngeal Carcinoma: a Prospective Observational Study	NCT05517135	Nasopharyngeal ...	Arm 1 Arm 2 Arm 3 Group 1 Group 2	21 Years - 99 Years	National Cancer Centre, Singapore
Intensified Treatments for Patients With Locally Advanced Nasopharyngeal Carcinoma With Detectable EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy	NCT05772208	Nasopharyngeal ...	Camrelizumab Nimotuzumab neoadjuvant che...	18 Years - 70 Years	Fudan University
Tislelizumab and Metronomic Capecitabine as Maintenance in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma	NCT06093061	Nasopharyngeal ...	CCRT with Maint...	21 Years - 99 Years	National Cancer Centre, Singapore
A Trial of Adjuvant Chemotherapy in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy	NCT00370890	Nasopharyngeal ...	Adjuvant chemot...	18 Years -	Chinese University of Hong Kong
Epstein-Barr Virus Antibody and Epstein-Barr Virus DNA for Nasopharyngeal Carcinoma Screening	NCT05447169	Nasopharyngeal ...	EBV antibodies ... EBV DNA test	30 Years - 62 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for ebv dna

Every month we try and update this database with for ebv dna cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ebv dna

Every month we try and update this database with for ebv dna cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ebv dna cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.