Clinical Research Directory

Reduced-dose vs Standard-dose Irradiation for Low-risk Clinical Target Volume in Nasopharyngeal Carcinoma.

To evaluate the locoregional control, survival rate, toxicity, and quality of life in patients with nasopharyngeal carcinoma treated with reduced prophylactic irradiation doses to the Low-Risk Clinical Target Volume (CTV).

LDRT and Chemoimmunotherapy in NPC With Liver Metastasis

This study aims to evaluate the efficacy and toxicity of adding low-dose radiotherapy to chemoimmunotherapy as a first-line treatment for nasopharyngeal carcinoma patients with liver metastasis.

Becotatug Vedotin for LA-NPC With a Suboptimal Response to Induction Chemotherapy Combined With Immunotherapy

Based on the short-term efficacy and plasma EBV DNA levels following immuno-induction chemotherapy, patients with locally advanced nasopharyngeal carcinoma who derive different benefits from this treatment can be identified. For high-risk patients who do not respond to immuno-induction chemotherapy (defined as EBV DNA \>0 copies/mL or imaging response evaluation showing SD/PD after immuno-induction chemotherapy), the addition of becotatug vedotin, which has a different mechanism of action, during concurrent radiotherapy and the adjuvant phase may improve patient survival. Based on the above research and background, the investigators plan to conduct the first prospective, single-arm, phase II clinical study of becotatug vedotin in patients with locally advanced nasopharyngeal carcinoma who are suboptimal responsive to immuno-induction chemotherapy, aiming to obtain sufficient evidence-based medical data to provide an additional treatment option for the concurrent and adjuvant phases of nasopharyngeal carcinoma.

Toripalimab Combined With Different Platinum-Based Induction Chemotherapy Regimens for Locally Advanced Nasopharyngeal Carcinoma

This phase II randomized trial compares the efficacy and safety of Toripalimab combined with three different platinum-based induction chemotherapy regimens, sequentially followed by standard concurrent chemoradiotherapy, for the treatment of locally advanced nasopharyngeal carcinoma (NPC). The study is aimed to pick up the most effective platinum-based induction chemotherapy regimen plus Toripalimab for these patients which provides the most survival benefit.

MRG003 Combined With Immunotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial

This study was designed to compare the efficacy and safety of Becotatug Vedotin (MRG003) combined with Pucotenlimab as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma.

Anlotinib Plus Immunotherapy and Chemoradiotherapy for High-Risk Nasopharyngeal Carcinoma

This trial aimed to evaluate the efficacy of anlotinib hydrochloride combined with benmelstobart, induction chemotherapy, and concurrent chemoradiotherapy (IC+CCRT), versus a regimen of benmelstobart plus IC+CCRT, in patients with high-risk locoregionally advanced nasopharyngeal carcinoma (LANPC).

IMRT Alone for Stage IB Nasopharyngeal Carcinoma Without High-Risk Features

This observational study aims to evaluate the efficacy and safety of intensity-modulated radiotherapy (IMRT) alone in patients with stage IB nasopharyngeal carcinoma (NPC) without high-risk features. The primary objective is to determine the therapeutic effectiveness of this approach

Short-course Tislelizumab Combined With Chemoradiotherapy for Nasopharyngeal Carcinoma

This trial aim to explore whether short-course tislelizumab (3 cycles of 200 mg q3w in the induction phase and 3 cycles of 400 mg q6w in the consolidation phase) yields non-inferior event-free survival compared to long-course tislelizumab (3 cycles of 200 mg q3w in the induction phase and 5 cycles of 400 mg q6w in the consolidation phase) in patients with locoregionally advanced nasopharyngeal carcinoma.

LDRT Combined With Toripalimab and Chemotherapy for Recurrent/Metastatic NPC

This study aims to evaluate the efficacy and safety of LDRT combined with toripalimab and GP chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma through a prospective, open-label, single-arm Phase II clinical trial.

Prevention and Treatment of Radiation-Induced Oral Mucositis in NPC With Houyanqing Oral Liquid

To explore the efficacy of Houyanqing Oral Liquid combined with conventional treatment in preventing and treating radiation-induced oral mucositis, so as to improve the quality of life of nasopharyngeal carcinoma patients received radiotherapy.

Phase 3 Trial Comparing IMRT or IMPT Plus CIRT for Patients With NPC

The goal of this phase 3 non-inferiority trial is to compare the efficacy and toxicity of proton or photon radiation therapy plus carbon ion radiation therapy for newly diagnosed nasopharyngeal carcinoma. The main question it aims to answer is that if proton radiation therapy plus carbon ion radiation therapy is non-inferior to photon radiation therapy plus carbon ion radiation therapy in terms of therapeutic efficacy. Participants will be randomized to receive either proton radiation therapy (arm 1) or photon radiation therapy (arm 2), in addition to carbon ion radiation therapy (for both arms).

Tislelizumab Plus Chemotherapy With Response-Adapted Radiotherapy for de Novo Metastatic Nasopharyngeal Carcinoma: A Prospective, Phase II Trial

This study is aimed to evaluate the efficacy and safety of tislelizumab combined with chemotherapy and response-adapted radiotherapy in patients with de novo metastatic nasopharyngeal carcinoma

Concurrent Chemoradiotherapy With or Without Metronomic Capecitabine in High-Risk T1-2N1M0 NPC

This Phase III multicenter trial investigates treatment intensification for high-risk, stage T1-2N1M0 nasopharyngeal carcinoma. Patients with high-risk features (\>3 metastatic lymph nodes, necrosis, or confluence) receive concurrent chemoradiotherapy. Those with detectable EBV DNA during radiotherapy are randomized 1:1 to adjuvant capecitabine or observation alone to assess efficacy and safety

Adaptive Immunotherapy for Nasopharyngeal Carcinoma

1. To assess whether radiotherapy alone is non-inferior to concurrent chemoradiotherapy with respect to event-free survival and superior in reducing treatment-related nausea in low-risk locoregionally advanced nasopharyngeal carcinoma patients who achieve complete or partial response and undetectable serum EBV-DNA following induction chemoimmunotherapy. 2. To evaluate whether adjuvant capecitabine and immunotherapy after concurrent chemoradiotherapy improves event-free survival compared to adjuvant immunotherapy in high-risk locoregionally advanced nasopharyngeal carcinoma patients with stable disease or detectable serum EBV-DNA after induction chemoimmunotherapy.

Prospective Immuno-Radiomic Profiling in Nasopharyngeal Carcinoma Treated With Proton or Photon Chemoradiotherapy

To prospectively investigate and integrate radiomic and immunologic signatures in patients with nasopharyngeal carcinoma (NPC) treated with either proton or photon radiotherapy, with the aim of identifying biomarkers associated with treatment response, toxicity, and long-term outcomes.

Phase III Trial of EBV-DNA-Guided Adaptive Immunotherapy for Advanced Nasopharyngeal Carcinoma

This trial evaluated the efficacy of two adjuvant regimens following identical induction and concurrent chemoradiotherapy (IC+CCRT) in locoregionally advanced nasopharyngeal carcinoma (LANPC) patients with persistent EBV DNA positivity or stable disease after three IC cycles. The control arm received adjuvant adebrelimab, while the experimental arm received adebrelimab plus capecitabine.

Perioperative Chemotherapy and Immunotherapy for Locally Recurrent Nasopharyngeal Carcinoma

Nasopharyngeal carcinoma (NPC) is an endemic malignancy in Southern China and southeast Asia. Despite intensive radical therapy, between 15% and 30% of NPC patients develop relapse. Recent phase III randomized-controlled trials conducted in China demonstrated an improvement of progression-free survival with combinational therapy immune checkpoint inhibitors (ICI) (camrelizumab, toripalimab, and tislelizumab, respective) and chemotherapy gemcitabine (G) and cisplatin (P) compared with chemotherapy GP alone for recurrent or metastatic NPC. However, none of these studies have described in details the treatment outcomes of those subjects with locally recurrent NPC only, and whether any of these patients would undergo radical surgery to remove the residual locally recurrent NPC after ICI and chemotherapy. Continuation of the same ICI as maintenance therapy may only be the treatment option for these patients who were recruited into these phase III trials, unless if they withdrew from the study and opted for radical resection. While continuing the same ICI may still lead to persistent objective response and disease control, there is a possibility of tumor recurrence leading to unresectable disease and a worse survival outcome, or unexpected, rare but recognized immune-related emergent adverse events with ICI. Radical resection after maximal response to ICI and chemotherapy for patients with locally recurrent NPC only may provide a chance of cure of the disease and these patients may be obviated from continuous exposure to ICI therapy. In view of the above, we are now proposing a phase II single-arm study on perioperative pembrolizumab and chemotherapy followed by radical surgery for locally recurrent NPC. As a collateral study, we will also perform single-cell DNA and RNA sequencing and proteomics study to observe the tumor and immune microenvironment which certainly helps us decipher the mechanisms of tumor response at genomic, transcriptomic and proteomic levels.

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

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.

Radiotherapy Omitting Prophylactic Neck Irradiation With Neoadjuvant and Adjuvant Toripalimab in Nasopharyngeal Carcinoma

This single-arm, phase 2 trial evaluates the efficacy and safety of de-escalated radiotherapy (restricted to the primary tumor, omitting prophylactic neck irradiation) combined with neoadjuvant and adjuvant toripalimab immunotherapy, and concurrent chemotherapy in patients with nasopharyngeal carcinoma staged N0 or N1, where nodal involvement is strictly confined to the retropharyngeal lymph nodes.

Shrinking the Anterior Border of CTV2 for Nasopharyngeal Carcinoma to Reduce the Radiation of Nasal Cavity

This is a an open-label, non-inferiority, multicenter, randomized phase III trial aimed to explore the efficacy and safety of shrinking the anterior border of CTV2 in nasopharyngeal carcinoma patients without tumor invasion into the posterior nasal aperture.

Tislelizumab Combined With Capecitabine for Nasopharyngeal Carcinoma With Residual EBV DNA After Radiotherapy

This study aims to explore the efficacy and safety of tislelizumab combined with capecitabine in nasopharyngeal carcinoma patients with residual plasma EBV DNA after radiotherapy.

SBRT Combined With Nimotuzumab and Tislelizumab for Oligoprogressive Recurrent/Metastatic Nasopharyngeal Carcinoma After Failure of Immunotherapy

This study is a single-arm, open-label, prospective, and exploratory investigation aimed at examining the short-term efficacy, specifically the objective response rate (ORR), of SBRT combined with Nimotuzumab followed by Tislelizumab in patients with recurrent/metastatic nasopharyngeal carcinoma who have experienced oligoprogression (1-5 metastatic lesions) after immunotherapy.

Impact of Vitamin D on Therapeutic Respons in NPC Chemoradiated Patients

Nasopharyngeal cancer is the sixth most common cancer and the sixth leading cause of death in Indonesia. NPC is a radiosensitive cancer so radiotherapy is the basic therapy for NPC. Concurrent chemoradiotherapy (CCRT) with Intensity modulated radiotherapy (IMRT) is the standard therapy for locally advanced NPC. Vitamin D deficiency is common in patients with head and neck cancer including NPC. Several studies have shown better outcomes and fewer complications of therapy in patients with higher vitamin D levels. Inflammation plays an important role in tumor development and progression. The effect of vitamin D supplementation on cancerous and precancerous lesions shows that there is a potential for major changes in IL-6 levels. By supplementing vitamin D in NPC patients with vitamin D deficiency before undergoing chemoradiation, it will increase the therapeutic response and reduce IL-6 levels (proinflammatory cytokines). Until now, there have been no studies evaluating the administration of vitamin D supplementation in NPC patients with vitamin D deficiency undergoing chemoradiation in Indonesia.

International Collaborative Study on AJCC/UICC TNM-10 for Nasopharyngeal Cancer

The goal of this international, multicenter, prospective observational study is to improve prognostication and prediction of failure pattern for nasopharyngeal carcinoma (NPC), in order to provide more accurate guidance for personalized treatment decision. Firstly, we aim to improve the fundamental TNM staging system (current AJCC/UICC TNM Version-Nine) based on universally assessable anatomical parameters. Secondly, we aim to further refine prognostication for individual patients by integrating anatomical TNM parameters with non-anatomical factors and molecular biomarkers. In addition to the core group of participating centers from China (including Hong Kong) where NPC is most prevalent, the study will enrol patients from multiple countries/regions including those from non-endemic areas to provide global data. Patients treated with contemplary treatment methods during October 2025 to September 2026 will be recruited and they will be followed up for 5 years to generate detailed records for robust evaluation. Key Questions: * To achieve optimal improvement of anatomically based AJCC/UICC TNM Classification for global application * To achieve precise prediction of failure pattern for individual patients by integration of TNM system and non-anatomical prognostic factors/molecular biomarkers Recruited patients with confirmed histological diagnosis of NPC will undergo standard clinical evaluations and receive treatment per institutional guidelines. The anatomical extent of disease at presentation will be evaluated by experienced radiologists and oncologists. The patient will be followed up for 5 years and clinical outcome will be recorded for analyses on correlation with prognostic factors. This study will be another important milestone for NPC staging because firstly, this is the first time that the data are based on prospective data to ensure comprehensive coverage of all essential evidence; and secondly, this is the first time that centers from non-endemic countries/regions will also participate to ensure that the final recommendations are globally applicable. The findings will provide valuable evidence for the development of the AJCC/UICC TNM Version-Ten staging system and prognostic system to improve risk stratification for designing personalized treatment strategy, ultimately leading to improvement of patient outcome and patient selection for future research worldwide.