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Nasopharyngeal Carcinoma

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

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Gemcitabine

Cisplatin

Immunoglobulins

HLX07

HLX10

placebo

gemcitabine 1000 mg/m2, D1,D8; cisplatin 80 mg/m2,D1；Q3W, up to 6 cycles

chemotherapy

Li Zhang

A Randomized, Double-Blind, Multi-Center Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) + Serplulimab (HLX10, Recombinant Anti-PD-1 Humanized Monoclonal Antibody) +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 + Serplulimab +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic NPC

A Randomized, Double-Blind, Multi-Center Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) + Serplulimab (HLX10, Recombinant Anti-PD-1 Humanized Monoclonal Antibody) +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

Objective response rate (ORR) (assessed by the IRRC according to the RECIST v1.1 criteria)

Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by the IRRC and INV according to the RECIST v1.1 criteria.

Shanghai Henlius Biotech

Patients with newly diagnosed, non-metastatic NPC was given New-mode reduce-volume target IMRT. The CTVp was defined as a subclinical disease consisting of 10 mm margin surrounding GTVnx (not including all nasopharyngeal mucosa)

Patients with newly diagnosed, non-metastatic NPC was given conventional reduce-volume target IMRT. The CTVp was defined as GTVnx + entire nasopharynx mucosa + 10 mm + corresponding anatomical structures.

The CTVp was defined as a subclinical disease consisting of 10 mm margin surrounding GTVnx (not including all nasopharyngeal mucosa)

New-mode reduce-volume target IMRT

This is a randomized, phase III, prospective, multi-center trial in newly diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. The aim of this study is to evaluate the efficacy and safety of new-mode reduced volume IMRT versus conventional IMRT, and compare the radiotherapy-related adverse events and quality of life in two groups.

New-mode Clinical Target Volume Delineation of Nasopharyngeal Carcinoma

New-mode Clinical Target Volume Delineation and Dosimetric Analysis in Nasopharyngeal Carcinoma Treated With Intensity-Modulated Radiotherapy

The duration of time to LFFS was calculated from the date of histological diagnosis until documented treatment local failure or death from any cause.

Fujian Cancer Hospital

The contralateral CTV1 was defined as a subclinical disease consisting of 5mm margin surrounding GTVnx.The CTV2 was defined as potentially involved regions consisting of 5mm margin surrounding CTV1, and contralateral CTV2 only included the pharyngeal recess.

The CTV1 was defined as GTVnx + 5 mm + entire nasopharynx mucosa .The CTV2 was defined as GTV1+ 5 mm + corresponding anatomical structures.

The contralateral CTV1 was defined as a subclinical disease consisting of 5mm margin surrounding GTVnx.The CTV2 was defined as a potentially involved regions consisting of 5mm margin surrounding CTV1, and contralateral CTV2 only included the pharyngeal recess.

CTV optimized IMRT

Yuwei Wang, M.M.

Ying Wang, Ph.D,M.D.

Ying Wang, Ph.D, M. D.

Ying Wang, Ph.D, M.D.

This is a prospective, single-center clinical trial in eccentric nasopharyngeal carcinoma (NPC) patients. The aim of this study is to evaluate the efficacy and safety of NBI combined with MRI-guided optimized CTV compared with conventional CTV, and to compare the radiotherapy-related adverse events and quality of life between the two groups.

All patients with eccentric nasopharyngeal carcinoma were selected on the basis of MRI findings and NBI endoscopy was performed in these patients. The patients were enrolled if both NBI endoscopy and MRI showed eccentric NPC. Patients with contralateral tissue mucosal abnormalities detected by NBI and confirmed by biopsy were excluded. Then the patients were randomly divided into an experimental group (Optimized CTV) or a control group (Conventional CTV) to evaluate the efficacy and safety of the two groups, as well as radiotherapy-related adverse events.

NBI Combined With MRI to Guide CTV Optimization in Eccentric Nasopharyngeal Carcinoma

Endoscopic NBI Combined With MRI to Guide the Optimization of Clinical Target Volume Delineation in Eccentric Nasopharyngeal Carcinoma

The acute adverse reactions of patients during or after radiotherapy were evaluated with the corresponding standard scales.

The duration of time to LRFS was calculated from the date of histological diagnosis until documented treatment local failure or death from any cause.

Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.

Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.

Chongqing University Cancer Hospital

Associate Director of Chongqing University Cancer Hospital

Digestive System Diseases

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Acute Graft Versus Host Disease

This group aims to develop an artificial intelligence model using a retrospective cohort to predict severe RIOM in patients diagnosed with LA-NPC and evaluate risk factors for severe RIOM and further validate the effectiveness of this risk factor in reducing the risk of severe RIOM on risk factors for severe RIOM identified by the predictive model.The oral evaluation of all patients was conducted by the same senior dentist, who evaluated the oral mucosal radiation toxicity weekly at baseline (before RT) and after RT, and performed RIOM scores.RIOM is classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0) .

Intervention based on key factors identified by the severe RIOM prediction model

Yu Zeng, Dr.

Exploring effective risk prediction models for severe Radiation-Induced Oral Mucositis (RIOM/RTOM), providing a research basis for mitigating oral radiation toxicity, and effectively improving the sensitivity of dentists in predicting the risk of severe RIOM in locally advanced nasopharyngeal carcinoma patients.Based on precise radiotherapy, it is proposed to extract OAR using the contour of local oral areas. Explore more accurate RIOM dose-response relationships.Exploring a new type of fusion classifier, by complementing the information between each base classifier, helps to maximize the utilization of the information contained in different factors to build a more objective, reliable, and efficient multi criteria decision-making based risk prediction model for severe RIOM. It use predictive models to identify key risk factors for severe RIOM and further validate the effectiveness of this risk factor in reducing the risk of severe RIOM on risk factors for severe RIOM identified by the predictive mode.

This study investigates the prediction and management of Radiation-Induced Oral Mucositis (RIOM/RTOM) in patients with locally advanced nasopharyngeal carcinoma undergoing radiotherapy. RIOM is a significant concern due to its impact on the quality of life for patients and its potential to disrupt radiotherapy courses, affecting local tumor control rates. We systematically analyzed multifaceted data, including dosimetric parameters, clinical factors, and oral variables, to develop a predictive model for severe RIOM. The effectiveness of key risk factors in mitigating the risk of severe RIOM was further validated to predict and potentially prevent severe RIOM.

Predictive Study on Acute Radiation Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients

Risk Prediction of Severe Radiation-induced Oral Mucositis in Locally Advanced Nasopharyngeal Carcinoma

According to the Clinical oral dryness score(CODS),A total of 10 features were used to obtain the total CODS. A high total score indicates increased oral dryness.

Evaluation of salivary PH using pH indicator paper

The evaluation of pain is based on the Numerical Rating Scale (NRS), with a numerical score of 0-10. A score of less than 5 is considered mild pain, a score of 5-7 is moderate pain, and a score of 8 or above is severe pain.

According to the CTCAE V5.0 ，Grade 3 and Grade 4 is considered severe RTOM

Patient factors, disease factors, and treatment related factors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 + Serplulimab +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic NPC	NCT05513573	Nasopharyngeal ...	HLX07 HLX10 placebo chemotherapy	18 Years -	Shanghai Henlius Biotech
New-mode Clinical Target Volume Delineation of Nasopharyngeal Carcinoma	NCT06095154	Nasopharyngeal ...	New-mode reduce...	-	Fujian Cancer Hospital
NBI Combined With MRI to Guide CTV Optimization in Eccentric Nasopharyngeal Carcinoma	NCT06167109	Nasopharyngeal ...	CTV optimized I...	18 Years -	Chongqing University Cancer Hospital
Predictive Study on Acute Radiation Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients	NCT05858385	Nasopharyngeal ... Radiation Induc...	Intervention ba...	18 Years - 75 Years	Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Predictive Study on Acute Radiation Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients	NCT05858385	Nasopharyngeal ... Radiation Induc...	Intervention ba...	18 Years - 75 Years	Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Spots Global Cancer Trial Database for nasopharyngeal carcinoma by ajcc v8 stage