Nasopharyngeal Carcinoma (NPC)

This Phase II study is a clinical trial exploring the efficacy and safety of BL-B01D1 with or without PD-1 monoclonal antibody in patients with high-risk locally advanced nasopharyngeal carcinoma.

This multicenter, prospective, observational cohort study aims to evaluate a previously developed dynamic risk prediction model for severe treatment-related myelosuppression in patients with nasopharyngeal carcinoma receiving systemic therapy. The model is designed to estimate the risk of grade 3 or higher anemia, thrombocytopenia, and leukopenia or neutropenia during treatment. Eligible adult patients with histologically confirmed nasopharyngeal carcinoma will be consecutively enrolled at participating centers. Before each cycle of systemic therapy, routinely available clinical and laboratory data will be collected and used to generate updated risk predictions. Patients will be followed throughout systemic therapy and for 28 days after the last treatment. This is an observational study. Treatment and supportive care will be determined by treating physicians according to routine clinical practice. Model predictions will be used only for research evaluation and will not be used to guide or modify patient treatment. The study will evaluate the predictive performance and clinical applicability of the model across multiple centers.

This trial is a registrational Phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of PD-1 monoclonal antibody combined with chemotherapy, followed by maintenance therapy with PD-1 monoclonal antibody with or without BL-B01D1, as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma.

This Phase Ib/II study is a clinical trial to evaluate the efficacy and safety of BL-M08D1 for Injection in patients with recurrent or metastatic nasopharyngeal carcinoma and other solid tumors.

The purpose of this study is to establish a comprehensive and integrated nasopharyngeal carcinoma screening cohort, which includes an epidemiological information database containing basic information, gender, age, ethnic and family history, dietary and lifestyle habits, and geographical environmental factors; a biobank of blood, tissue fluid, swabs, etc., for Epstein-Barr virus, tumors, and genetics; a clinical examination database including nasopharyngoscopy, imaging, pathology, and other examinations; and databases of Epstein-Barr virus and human genetic sequencing, etc.

To evaluate whether the 2-year local failure-free survival (LRFFS) in Cohort 1 patients with AJCC/UICC 8th edition stage IB-II nasopharyngeal carcinoma who achieved EBV-DNA = 0 after induction chemotherapy and had MRI assessment of complete response (CR) or partial response (PR) ≥50% is non-inferior when treated with reduced-dose IMRT (59.4 Gy/27 fractions) compared to standard-dose IMRT (66.0 Gy/30 fractions).

This is an observational cohort study designed to (1) evaluate whether Gallium-68 (68Ga)-labeled fibroblast activation protein inhibitor ligand LM3 (68Ga-FAPI-LM3) positron emission tomography/computed tomography (PET/CT) improves the accuracy of nasopharyngeal carcinoma (NPC) staging, and (2) determine whether Gallium-68-labeled programmed death-ligand 1 (68Ga-PD-L1) PET/CT imaging parameters can provide early prediction of response to neoadjuvant immunotherapy. The study will assess the sensitivity and specificity of each tracer for staging and for predicting therapeutic response, analyze changes in tumor uptake parameters on 68Ga-FAPI-LM3 and 68Ga-PD-L1 PET/CT before and after treatment, and compare treatment efficacy and survival outcomes between patients with different degrees of residual PET uptake and between those who did and did not receive neoadjuvant immunotherapy. The primary question it aims to answer is: Does 68Ga-FAPI-LM3 PET/CT improve the accuracy of NPC staging, and can 68Ga-PD-L1 PET/CT imaging parameters provide an early prediction of response to neoadjuvant immunotherapy? Participants will be patients with biopsy-proven nasopharyngeal carcinoma who undergo 68Ga-FAPI-LM3 and/or 68Ga-PD-L1 PET/CT as part of clinical care or a research protocol. Tumor uptake metrics (e.g., maximum standardized uptake value (SUVmax), mean standardized uptake value (SUVmean), metabolic/volumetric indices) will be measured pre- and post-treatment; diagnostic performance (sensitivity, specificity) and associations between uptake changes and clinical outcomes (response rates, progression-free and overall survival) will be calculated.

This study plans to enroll patients with histologically or cytologically confirmed locally recurrent nasopharyngeal carcinoma. After signing informed consent, eligible subjects will receive three cycles of standard-dose becotatug vedotin combined with a PD-1 inhibitor. Following treatment, imaging assessment and surgical evaluation will be performed. Subjects deemed operable will undergo endoscopic nasal surgery, after which the MDT (multidisciplinary team) will discuss and determine a maintenance treatment plan. For subjects who are not eligible for surgery, the MDT will decide on either maintenance therapy or a switch to an alternative treatment regimen.

This multicenter, randomized controlled trial is designed to determine whether omitting prophylactic extraction of impacted teeth before radiotherapy leads to an unacceptably higher risk of jaw osteoradionecrosis (JORN) compared with conventional prophylactic extraction in patients with non-metastatic nasopharyngeal carcinoma (NPC). JORN is a condition in which jawbone tissue is damaged and fails to heal properly after radiotherapy. A total of 536 eligible participants with at least one impacted tooth will be randomly assigned to either omit prophylactic extraction of impacted teeth before radiotherapy or undergo conventional prophylactic extraction before radiotherapy. All participants will receive standard curative-intent intensity-modulated radiotherapy (IMRT), with chemotherapy administered when indicated according to the study protocol. Participants will be followed for up to 5 years. The primary outcome is the incidence of JORN within 2 years after completion of radiotherapy. Secondary outcomes include longer-term incidence of JORN, overall survival, locoregional relapse-free survival, distant metastasis-free survival, quality of life, and treatment-related toxicities.

This study aims to explore the efficacy and safety of risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI in nasopharyngeal carcinoma patients.

The RADIANCE trial plans to enroll patients with chemotherapy-ineligible de novo metastatic nasopharyngeal carcinoma (AJCC 9th edition, TxNxM1). Participants will receive Radscopal radiotherapy, consisting of low-dose radiotherapy to the primary lesions and stereotactic body radiotherapy to distant metastatic lesions, in combination with sintilimab and ipilimumab. The study will evaluate the objective response rate of the primary lesions, systemic disease control as measured by progression-free survival and overall survival, and the safety and tolerability of this treatment regimen. The main questions this study aims to answer are: Does this treatment improve efficacy with acceptable safety in chemotherapy-ineligible patients? Does Radscopal radiotherapy enhance systemic antitumor immunity, and what is the Radscopal Response Rate? What clinical and immunological factors are associated with the Radscopal effect, and what mechanisms may underlie this effect?

Immunotherapy combined with chemoradiotherapy has become standard care for locally advanced nasopharyngeal carcinoma, yet radiotherapy-induced lymphopenia may impair the efficacy of concurrent PD-1 blockade. Existing evidence supports synergistic anti-tumor activity between the anti-EGFR antibody nimotuzumab and toripalimab. This multicenter, open-label, non-inferiority Phase III trial randomizes eligible stage III-IVA LA-NPC patients 1:1 to two arms. The experimental group receives an "immune sandwich" regimen: TPC induction plus nimotuzumab and toripalimab, concurrent radiotherapy with weekly nimotuzumab only, followed by toripalimab maintenance. The control arm adopts full-course toripalimab throughout induction, concurrent radiotherapy and adjuvant phases. The primary endpoint is 3-year event-free survival, with secondary endpoints covering overall survival, local/distant control rates, objective response rate and treatment-related toxicities. A total of 566 subjects will be enrolled to verify whether the simplified sandwich strategy delivers non-inferior survival with better safety profiles.

This trial aims to study the role of Ivonescimab combined with chemoradiotherapy in high-Risk locoregionally advanced nasopharyngeal carcinoma.

Proton therapy for nasopharyngeal carcinoma can reduce radiotherapy-related toxic reactions, and some retrospective studies have found that proton therapy improves the survival of patients with nasopharyngeal carcinoma. However, high-level prospective clinical evidence is still lacking. This study aims to investigate the efficacy and side effects of proton therapy compared with photon intensity-modulated radiotherapy for nasopharyngeal carcinoma through a multicenter, prospective, phase III clinical trial, providing more high-quality evidence-based medical evidence for proton therapy of nasopharyngeal carcinoma.

While existing data supports the use of acupuncture to reduce radiation-induced xerostomia, the optimal timing of acupuncture for managing chemoradiation-induced xerostomia remains an area of active investigation. Prior studies have administered acupuncture either in patients who developed xerostomia 12 months after radiation 10 or during the radiation therapy itself 9. The hypothesis is that acupuncture may be more effective in preventing and reducing xerostomia when administered early during CRT, rather than after chronic xerostomia has already set in. Yet, oncologists have concerns about the potentially higher risk of complications, such as infection, associated with acupuncture, especially if administered concurrently with chemoradiotherapy. Therefore, this study aims to conduct this randomised trial to evaluate the impact of early versus delayed acupuncture on patient-reported and objective measures of xerostomia, as well as the safety and tolerability of acupuncture in this setting. To our knowledge, this will be the first randomised clinical trial evaluating the optimal timing for incorporating acupuncture to reduce xerostomia in patients undergoing chemoradiation for head and neck cancers. It is also the first study conducted in Singapore to study the role of acupuncture in reducing CRT-induced xerostomia.

This is a phase 2, multicentre, open-label, randomised, controlled trial with a parallel-group design. The study aims to evaluate the efficacy and safety of single-agent Becotatug Vedotin as adjuvant therapy in patients with high-risk locoregionally advanced nasopharyngeal carcinoma (NPC).

This study aims to evaluate a personalized approach for treating patients with locoregionally advanced nasopharyngeal carcinoma (NPC). Currently, many high-risk patients receive additional treatment (adjuvant therapy) after standard chemoradiotherapy to prevent the cancer from returning. However, some patients may not actually need this extra treatment and could safely avoid its side effects. This trial uses a novel risk prediction model called the Response-Adapted Individualized Risk Index (RAIRI). The RAIRI model evaluates how a patient's tumor and blood markers (such as Epstein-Barr Virus DNA) respond during and immediately after their initial chemoradiotherapy. In this study, patients will be randomly assigned to one of two groups: 1. Standard Treatment Group: All patients will receive standard adjuvant therapy (either a PD-1 inhibitor or capecitabine) after completing their initial chemoradiotherapy. 2. RAIRI-Guided Group (Experimental): Patients will be evaluated using the RAIRI model after initial chemoradiotherapy. Only those identified as "high-risk" by the model will receive adjuvant therapy. Those identified as "low-risk" will be exempted from adjuvant therapy and will undergo regular observation. The main goal of this study is to determine if using the RAIRI model to exempt low-risk patients from adjuvant therapy is as safe and effective as giving adjuvant therapy to everyone, measured by how long patients live without the disease returning or progressing.

This prospective, multicenter, real-world observational study aims to evaluate whether a response-adapted individualized risk index, the RAIRI model, can identify patients with non-metastatic nasopharyngeal carcinoma who may or may not benefit from adjuvant therapy after standard chemoradiotherapy. Patients will receive standard treatment according to routine clinical practice. After completion of chemoradiotherapy and assessment at approximately 1 month after radiotherapy, longitudinal multimodal response data, including plasma cfEBV DNA dynamics and MRI-based tumor response, will be incorporated into the RAIRI model to estimate the predicted 5-year progression-free survival. Patients will be stratified into a RAIRI low-risk group, defined as predicted 5-year PFS ≥85%, and a RAIRI high-risk group, defined as predicted 5-year PFS \<85%. Within each RAIRI risk stratum, outcomes will be compared between patients who receive adjuvant systemic therapy, mainly PD-1 inhibitor-based adjuvant immunotherapy, and those who undergo routine surveillance without adjuvant systemic therapy. The primary endpoint is 3-year failure-free survival. Secondary endpoints include overall survival, locoregional relapse-free survival, distant metastasis-free survival, complete response rate after chemoradiotherapy, distribution of RAIRI risk groups, adverse events, late toxicities, and longitudinal health-related quality of life.

This clinical trial aims to understand whether taurine can prevent and reduce severe radiation-induced oral mucositis in patients with nasopharyngeal carcinoma undergoing radiotherapy.

This study is designed as a single-arm, open-label, phase II trial to evaluate the efficacy and safety of ivonescimab in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have progressed on prior an immune checkpoint inhibitor and platinum-based chemotherapy.

This study aims to evaluate the effectiveness and safety of endoscopic nasopharyngeal pseudomembrane removal in reducing radiation-induced nasopharyngeal necrosis in patients with recurrent nasopharyngeal carcinoma who have received re-irradiation. This is a prospective, single-arm, multicenter interventional study. Participants with recurrent nasopharyngeal carcinoma who develop pseudomembrane reaction during or after re-irradiation will receive endoscopic pseudomembrane removal. Based on published literature, the 2-year incidence of radiation-induced nasopharyngeal necrosis after re-irradiation is approximately 40%. This study expects to reduce the incidence to 20%. The primary outcome measure is the 2-year incidence of nasopharyngeal necrosis after re-irradiation. Secondary outcome measures include: necrosis-free survival, overall survival, progression-free survival, local regional recurrence-free survival, distant metastasis-free survival, as well as safety and adverse events. A total of 40 participants will be enrolled from multiple hospitals in China.

This clinical trial aims to determine whether Natural Killer (NK) cell therapy administered in combination with concurrent chemoradiotherapy (CRT) can reduce recurrence in patients with advanced nasopharyngeal cancer (NPC), and to identify the highest safe and tolerable dose of allogeneic NK cells. Allogeneic NK cells, derived from healthy donors, have demonstrated good tolerability in cancer patients. The primary research questions are: 1. What is the maximum tolerated dose (MTD) of allogeneic NK cells when administered with CRT in NPC patients? 2. Can the addition of allogeneic NK cells to standard CRT reduce the proportion of NPC patients with detectable plasma EBV-DNA from 30% to 10%? Phase 1: Participants will receive one of five escalating doses of allogeneic NK cells with CRT to determine the MTD. Phase 2: Participants will receive the established MTD NK dose together with CRT. Participants will undergo regular safety monitoring, side-effect assessment, measurement of plasma EBV-DNA levels, and surveillance for disease recurrence.

This study is a multicenter, randomized, controlled phase III clinical trial aiming to investigate the efficacy and safety of Becotatug Vedotin induction therapy followed by concurrent chemoradiotherapy (CCRT) combined with neoadjuvant and adjuvant sintilimab, versus gemcitabine plus cisplatin (GP) induction chemotherapy followed by CCRT, in the treatment of high-risk locally advanced nasopharyngeal carcinoma (LANPC). The study plans to enroll 266 patients with high-risk NPC (AJCC 9th edition, anyT N2-3M0 or T4N1M0), who will be randomly assigned to the experimental group or the control group at a 1:1 ratio.The primary endpoint is 3-year event-free survival (EFS), and the secondary endpoints include overall survival (OS), local-regional failure-free survival (LRFFS), distant metastasis-free survival (DMFS), objective response rate (ORR), adverse events, and quality of life.

Radiation therapy is the main treatment for nasopharyngeal carcinoma (NPC), and standard care for advanced NPC often includes combination chemotherapy and radiation (CCRT). However, many patients experience serious side effects, such as painful mouth sores (Radiation-Induced Oral Mucositis, RTOM). These side effects can be so severe that they lower a patient's ability to adhere to treatment, potentially making the CCRT less effective. Studies have shown that a significant number of patients stop treatment early due to this toxicity. Current clinical guidelines from organizations like MASCC/ISOO and ESMO agree that preventing RTOM is crucial, but there is currently no specific drug that works for everyone. This study aims to investigate a new approach: using Sapylin, a biological immune regulator, delivered through an atomized inhaler. Preliminary research suggests Sapylin delivered this way may enhance the effectiveness of chemotherapy and boost the body's immunity. The main purpose of this study is to determine the effect of Sapylin inhalation on the incidence and severity of RTOM, and to evaluate its safety and impact on the overall success of CCRT. By participating, you will help researchers find a high-efficiency, low-toxicity method to improve CCRT outcomes and manage RTOM for future NPC patients and specialists.

This study aims to explore the efficacy and safety of scipibaimab combined with tislelizumab in patients with recurrent or metastatic nasopharyngeal carcinoma who have progressed after first-line therapy.