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Nasopharyngeal Carcinoma clinical trials

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NCT ID: NCT06445088 Recruiting - Clinical trials for Nasopharyngeal Carcinoma

Diagnostic Accuracy of EBV C Promoter Methylation Kit in Nasopharyngeal Carcinoma

Start date: May 29, 2024
Phase:
Study type: Observational [Patient Registry]

This clinical study aims to evaluate the diagnostic performance of a new Epstein-Barr virus (EBV) C promoter methylation detection kit. All participants will undergo a series of diagnostic tests including VCA-IgA, EBNA1-IgA, and EBV-DNA assays. Additionally, nasopharyngeal swabs will be analyzed for EBV C promoter methylation. Confirmatory biopsy will be performed on all patients to establish a definitive diagnosis. This comprehensive approach seeks to assess the effectiveness of the methylation detection kit in a clinical setting.

NCT ID: NCT06383780 Recruiting - Clinical trials for Nasopharyngeal Carcinoma

Tislelizumab in Combination With GP or TPC Regimen for the Treatment of Nasopharyngeal Carcinoma With Bone Metastasis.

Start date: May 15, 2024
Phase: Phase 3
Study type: Interventional

This is a prospective, open-label phase III clinical trial evaluating the efficacy and safety of the GP(Gemcitabine combined with cisplatin) regimen in combination with Tislelizumab versus the TPC(cisplatin, nab-paclitaxel and capecitabine)regimen in combination with Tislelizumab for the first-line treatment of Nasopharyngeal Carcinoma patients With Bone Metastasis.

NCT ID: NCT06321939 Recruiting - Clinical trials for Nasopharyngeal Carcinoma

Sequencing-based Counting of Plasma Epstein-Barr Virus DNA in Non-metastatic Nasopharyngeal Carcinoma

Start date: January 11, 2024
Phase:
Study type: Observational

The investigators aim to explore a new EBV DNA surveillance method with both high sensitivity and specificity in nasopharyngeal carcinoma (NPC) patients. the investigators aim to conduct plasma EBV DNA counting by next generation sequencing (NGS) in non-metastatic NPC patients on their diagnose, after two cycles of induction chemotherapy (IC), and 4-8 weeks after definitive radiotherapy. The investigators aim to explore whether sequencing-based counting is better than PCR analysis in plasma EBV-DNA surveillance, so as to monitoring tumor responses to treatment and for guiding individualized treatment adaptation in the future.

NCT ID: NCT06313450 Recruiting - Clinical trials for Nasopharyngeal Carcinoma

De-escalated Radiotherapy for Primary Tumor After Neoadjuvant Therapy With Toripalimab Plus Chemotherapy for Nasopharyngeal Carcinoma

Start date: March 4, 2024
Phase: N/A
Study type: Interventional

In the IMRT era, patients with stage II-III (AJCC8th) nasopharyngeal carcinoma achieve high local control. However, survivors are increasingly experiencing late radiation-induced toxicities. A previous study found that reducing the radiation dose to the primary site to 60Gy for patients who achieved partial or complete response to induction chemotherapy resulted in a lower rate of late toxicities and an inferior local control rate. The investigators aim to reduce the radiation dose to the primary site for patients after immunochemotherapy, given the potential of neoadjuvant chemotherapy and immunotherapy to increase response rates and long-term survival. The protocol includes participants with stage II-III (AJCC8th), except T2N0M0, to receive three courses of neoadjuvant gemcitabine plus cisplatin and Toripalimab. If the primary tumour regresses by over 75%, de-escalated radiotherapy with 60Gy will be administered, and participants will receive two cycles of cisplatin and three cycles of Toripalimab during the radiotherapy course. Otherwise, participants will receive conventional radiotherapy and concurrent chemotherapy with cisplatin for two cycles as usual. The aim of this study is to investigate the 3-year local control rate and toxicities of de-escalated radiotherapy.

NCT ID: NCT06308328 Recruiting - Clinical trials for Swallowing-induced Breakthrough Pain

A Real-world Observational Study of a Mucosal Contouring Method for Radiation-induced Oropharyngeal Mucositis

Start date: April 1, 2024
Phase:
Study type: Observational

The performance of the predictive models for the occurrence and severity of oropharyngeal mucositis established using either oral cavity contouring method or mucosa surface contouring method was unsatisfactory in nasopharyngeal carcinoma (NPC). Whereas the predictive model of a mucosal contouring method based on swallowing-induced breakthrough pain exhibited better overall performance in locally advanced NPC. Therefore, the investigators aimed to conduct a prospective, multicenter, real-world observational study to further assess the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC.

NCT ID: NCT06307314 Recruiting - Clinical trials for Head and Neck Cancer

Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis

Start date: February 1, 2024
Phase:
Study type: Observational

Head and neck squamous cell carcinoma (SCC) is the sixth most common cancer worldwide, with more than 700,000 new cases and more than 350,000 deaths each year. At present, radiotherapy is an important measure to control the recurrence of head and neck tumors, but almost all patients with head and neck squamous cell carcinoma will have acute inflammatory reactions such as radiotherapy-induced oral mucositis (RIOM) after radiotherapy, which seriously affects the quality of life and radiotherapy efficacy of patients. Serum amyloid A1 (SAA1) is an acute phase protein associated with inflammation. Our previous basic research found that serum SAA1 expression levels can be used as biomarkers to assess the dose received by the receptor in the early stages of radiation damage. At the same time, we confirmed that the serum level of SAA1 in patients with nasopharyngeal carcinoma increased after radiotherapy. Therefore, we intend to conduct a prospective, multicenter, observational study to further explore the predictive power of plasma SAA1 levels for radiotherapy-induced oral mucositis, with a view to early screening and prevention of RIOM patients.

NCT ID: NCT06301165 Recruiting - Clinical trials for Nasopharyngeal Carcinoma

TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma

Start date: March 19, 2024
Phase: Phase 2
Study type: Interventional

The NCCN guidelines recommend induction chemotherapy followed by concurrent chemoradiotherapy as the standard treatment for locoregionally advanced nasopharyngeal carcinoma (NPC). However, meta-analyses have shown significant survival differences between different induction chemotherapy regimens. How to choose an induction chemotherapy regimen and treatment course that ensures definitive therapeutic effects and low incidence of toxic side effects remains a hot spot in clinical research. Polymeric micellar paclitaxel are an innovative form of paclitaxel drugs, with high penetration and long retention effects, which can enter the vascularly disordered tumor microenvironment through passive targeting and form higher concentrations in tumor tissue. It remains to be investigated whether the TPC (paclitaxel, cisplatin and capecitabine) regimen based on polymeric micellar paclitaxel compared to the current standard first-line induction chemotherapy GP (gemcitabine, cisplatin) regimen can further improve therapeutic effects in high-risk patients with locally advanced disease. There is still a lack of head-to-head studies for comparison. This study aims to compare, through a prospective, parallel-controlled, randomized, open-label, multicenter phase II clinical trial, the TPC induction chemotherapy vs. the GP induction chemotherapy combined with concurrent chemoradiotherapy for the treatment of high-risk locoregionally advanced NPC (T4 or N2-3) in terms of 2-year progression-free survival, overall survival, overall response rate, toxic side effects, etc.

NCT ID: NCT06287788 Recruiting - Clinical trials for Swallowing-induced Breakthrough Pain

A Mucosal Contouring Method Based on Swallowing-induced Breakthrough Pain for Radiation-induced Oropharyngeal Mucositis

Start date: March 1, 2024
Phase:
Study type: Observational

The performance of the predictive models for severe oropharyngeal mucositis established using current oral mucosal contouring method was unsatisfactory in nasopharyngeal carcinoma (NPC). Whereas the predictive model of a mucosal contouring method based on swallowing-induced breakthrough pain exhibited better overall performance. The aim of this prospective, multicenter, observational study was to further explore the predictive efficacy of this mucosal delineation method for radiation-induced oropharyngeal mucositis in NPC.

NCT ID: NCT06282497 Recruiting - Clinical trials for Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy

Xerostomia-optimised IMRT Versus Standard IMRT in NPC

Start date: October 23, 2023
Phase: N/A
Study type: Interventional

This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in NPC patients

NCT ID: NCT06277050 Recruiting - Clinical trials for Nasopharyngeal Carcinoma

Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma

Start date: March 7, 2024
Phase: Phase 3
Study type: Interventional

N3 classification, rENE positivity is a high-risk type of locally advanced nasopharyngeal carcinoma. EBV DNA remaining at detectable levels after induction chemotherapy is also a characteristic of high-risk nasopharyngeal carcinoma. Based on the available evidence, patients with high-risk nasopharyngeal carcinoma are recommended to receive oral maintenance therapy to reduce the risk of failure. The purpose of this study was to conduct a prospective, multicenter, randomized phase III clinical trial to determine whether maintenance therapy with triprilimab combined with capecitabine is better than maintenance therapy with capecitabine alone in high-risk nasopharyngeal carcinoma (N3+, rENE+, Detectable EBV DNA after 2 cycles of induction chemotherapy).