Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

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

Chemotherapy

Brigette Ma, MD, FRCP

The combination of pEBV DNA (half-life) and PET-CT following 1 course of chemotherapy allow earlier and more detection of drug response in advanced NPC than RECIST method, in patients with previously untreated advanced NPC who will receive platinum-based chemotherapy. This study will also determine if this new method can predict survival in these patients. This study may have far-reaching impact on drug development in NPC as it may offer a more optimal way of evaluating drug efficacy in clinical trials and also in clinical management.

New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer

Prospective Evaluation of Plasma EBV DNA Half-life and PET-CT Scanning as a New Tool in Assessing Early Response to Chemotherapy in Patients With Advanced Nasopharyngeal Carcinoma

Chinese University of Hong Kong

Comprehensive Clinical Trial Unit

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Docetaxel

Fluorouracil

Cisplatin

Test group: GP-induced chemotherapy (Gemcitabine 1000 mg/m2 d1, 8+Cisplatin 80 mg/m2 d1, once every 3 weeks, 4/6 course) + IMRT radiotherapy alone

Control group: TPF-induced chemotherapy (Docetaxel: 75 mg/m2d1, Cisplatin 75 mg/m2, d1\~d5, 5-fluorouracil 750 mg/m2/dd1\~d5, 4/6 course) + IMRT radiotherapy alone

Gemcitabine 1000 mg/m2 intravenously, d1\&d8 +Cisplatin 80 mg/m2 intravenously, d1 21\~28 days/cycle, 4 patients with oligometastasis, 6 cycles with multiple metastases

GP+IMRT

Docetaxel: 75mg/m2 intravenous drip, d1+Cisplatin75mg/m2 intravenous drip, d1\~d5+5-fluorouracil 750mg/m2/d intravenous drip, d1\~d521\~28 days/cycle, patients with oligometastasis take 4 cycles, moreTransfer patients for 6 cycles

TPF+IMRT

Feng Jin, Bachelor

Jinhua Long, Master

Feng Jin

Weili Wu

Yuanyuan Li

hong Tang

Xiuling Luo

Xiuyun Gong

Xiaoxiao Chen

Mainly compared with GP induction chemotherapy combined with IMRT and TPF induction chemotherapy combined with IMRT in the treatment of nasopharyngeal carcinoma, the cure rate, remission rate, treatment of distant metastases and lymph node metastasis, quality of life improvement rate, etc.

1. The main purpose: Whether the GP program can improve the efficiency of patients with nasopharyngeal carcinoma, especially overall survival (OS), in the TPF program. 2. Secondary purpose: To compare the progression-free survival (PFS) local failure-free survival (LR-FFS), the short-term remission rate of the tumor, the adverse chemotherapy response, and the treatment compliance Sex, as well as quality of life. 3. Significance of the research project Nasopharyngeal carcinoma is sensitive to radiotherapy and chemotherapy. Platinum-based chemotherapy is used in the treatment of distant metastasis and metastasis. It can effectively alleviate local symptoms and reduce local symptoms. The tumor volume thereby reduces the high dose area of the target area. Primary lesions and lymphatic drainage area radiotherapy can reduce tumor burden, relieve symptoms, and improve quality of life.

GP-induced Chemotherapy Combined With IMRT and TPF-induced Chemotherapy Combined With IMRT in the Treatment of Distant Metastatic Nasopharyngeal Carcinoma

Prospective Phase II Clinical Study of GP-induced Chemotherapy Combined With IMRT and TPF-induced Chemotherapy Combined With IMRT in the Treatment of Nasopharyngeal Carcinoma

Progress-free survival(year) is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up.

The OS(year) was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.

The LRFS(year) is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.

The DMFS(year) is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.

Tumour response(CR/PR/SD/PD) was classified according to RECIST v1.1

Incidence of acute toxicity（Grade1/2/3/4） is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria. 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

Guiyang Medical University

Head and neck cancer director, chief researcher, clinical professor

Central Nervous System Depressants

Other Dietary Supplements

Antibodies

Tislelizumab

Immunoglobulins

Benzocaine

Tannic Acid

SBRT: Metastases were treated with SBRT, GTV 45Gy/3F/3d, each course of radiotherapy only treated metastases within 1 organ.

Chemotherapy(GP or TP) was combined with tislelizumab for 4-6 cycles and tislelizumab was maintained until 2 years or disease progression or intolerable toxicity or death.

Maintain: (1) For newly diagnosed metastatic patients, nasopharyngeal and metastatic lymph node irradiation was started 4 weeks after systemic therapy, using IMRT technique, only radiating the GTV of the nasopharyngeal and cervical region, DT 66 Gy/30 F/6 weeks was recommended. Tislelizumab was continued during radiotherapy and tislelizumab was used during maintenance.

SBRT was added to systematic treatment (chemo+ PD-1 antibody)

SBRT

Feng Jiang, MD

feng Jiang, MD

Radiotherapy and immunotherapy have achieved good survival benefit in advanced nasopharyngeal carcinoma. A number of clinical studies of immunotherapy combined with radiotherapy for nasopharyngeal carcinoma are also ongoing. This study preliminarily explored the efficacy and safety of SBRT combined with tislelizumab and chemotherapy in metastatic nasopharyngeal carcinoma. Hypofractionated radiotherapy combine with systemic chemotherapy and immunotherapy in advanced nasopharyngeal carcinoma. Not only it can achieve rapid response of distant metastases, but also to achieve long-term survival benefit for patients, which provides the reference for subsequent studies.

SBRT for metastatic diseases combined with systemic therapy with GP chemotherapy plus PD-1 antibody

SBRT Combined With Chemotherapy and Tislelizumab in Metastatic NPC

Stereotactic Body Radiotherapy (SBRT) Combined With Chemotherapy and Tislelizumab in Metastatic Nasopharyngeal Carcinoma: A Single-arm, Phase Ⅱ Study

target lesion objective response rate after SBRT and 4-6 cycle chemo +immunotherapy

Zhejiang Cancer Hospital

Paclitaxel

Albumin-Bound Paclitaxel

ABX 140 mg/m2 day 1,8 + DDP 75mg/m2 day 1

ABX 100 mg/m2 day 1,8,15 + DDP 75mg/m2 day 1

ABX + DDP

Li Zhang, MD

This is a single center, non-randomized phase IIa study to determine the tolerance and safety of Abraxane (ABX) in combination with cisplatin (DDP) in patients with advanced nasopharyngeal carcinoma (NPC). Patients in whom the standard therapy had failed or had been infeasible will be eligible.The safety and efficacy will be evaluated according to NCI-CTCAE V4.0 and RECIST 1.1 respectively.

Nasopharyngeal carcinoma (NPC) is most commonly seen in Southeast Asia, especially in southern and southeastern China, where the incidence rate has been documented between 10 and 150 cases per 100,000 population per year. For advanced or metastatic NPC, chemotherapy remain the mainstay of treatment. The 130-nm albumin-bound formulation of paclitaxel (\[Abraxane, ABX \];Celgene,Summit,NJ) is a promising new agent with more efficient entry to the tumor microenvironment via caveolae-mediated transcytosis and preferential uptake by cancer cells. Superior activity of ABX-based regimens without the necessity for antianaphylactic pretreatments been shown in various solid tumors compared with the traditional solvent-based paclitaxel-based ones. However, the safety and efficacy of combination of ABX and cisplatin (DDP) has not been determined in patients with advanced NPC. In this single center, non-randomized phase IIa study, investigators seek to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of ABX-DDP, and perform an exploratory study of its efficacy as measured by tumor response.

Dose-finding Study of Abraxane in Combination With Cisplatin to Treat Advanced Nasopharyngeal Carcinoma

A Single Center Phase IIa Study of Nanoparticle Albumin-bound Paclitaxel in Combination With Cisplatin in Advanced Nasopharyngeal Carcinoma

Sun Yat-sen University

Professor

Symptoms and General Pathology

Recurrence

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

gemcitabine 1,000 mg/m2 over 30 to 60 minutes on days 1, 8, and plus cisplatin 80 mg/m2 on day 1, every 3 weeks.

5-Fluorouracil 4,000 mg/m2 CIV over 96 hours and plus cisplatin 80 mg/m2 on day 1, every 3 weeks.

The GP regimen consists of gemcitabine at a dose of 1,000 mg/m2 by intravenous (i.v.) infusion over 30 min on day 1 and day 8, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1 only

gemcitabine and cisplatin

The FP regimen consists of 5-Fluorouracil 1,000 mg/m2/day which was administered as a continuous intravenous infusion for 96 hours after completion of the cisplatin on days 1( 80 mg/m2 i.v. infusion for 4 h)

5-Fluorouracil and cisplatin

li zhang, doctor

The present study will be a randomized, control, multicenter phase III study of recurrent or metastatic (R/M) nasopharyngeal carcinoma (NPC) treated with Gemcitabine (Gemzar, Lilly) and cisplatin regimen (GP) or 5-Fluorouracil plus cisplatin regimen (FP). The population consists of recurrent or metastatic nasopharyngeal carcinoma (NPC) that failed the radical radiotherapy or chemotherapy-naïve advanced NPC (stage IV). The effectiveness and side effects will be evaluated according to Standard WHO response criteria and NCI-CTC AE V3.0.

Nasopharyngeal carcinoma (NPC) is most commonly seen in Southeast Asia, especially in southern and southeastern China ,where the incidence rate has been documented between 10 and 150 cases per 100,000 population per year. NPC is a radiosensitive tumor, and radiotherapy is considered to be the treatment of choice for most cases. The 5-year survival rate (all stages) is around 50% .In other words, more than half of the NPC cases will eventually fail radiotherapy and reasons of the failure are both local relapse and remote metastasis.

For these advanced or metastatic NPC, chemotherapy is the most important therapeutics,and they are relatively responsive to chemotherapy compared to other head and neck cancers. The backbone of the treatment for recurrent/metastatic (R/M) NPC is cisplatin containing regimen, which is also regarded as the standard regimen for other squamous cell carcinoma of head and neck (SCCHN). The FP regimen is widely used in R/M NPC patients now and its response rate is around 40%-65%,but the response period is usually short and the adverse reaction is frequent and badly tolerant, which influent the treatment compliance seriously. What's more, the catheters and pumps are necessary for continuous infusion of 5-Fluorouracil, which add to the cost, immobility and inconvenience of the treatment.

Preclinical and clinical data show synergistic activity between gemcitabine and cisplatin without overlapping toxicity. Several clinical trials enrolling a minority of advanced NPC patients suggest GP regimen has promising effectiveness and well tolerated side effects, and they indicated a potential possibility that the GP regimen comes to the standard first line choice instead of the FP regimen

Effect and Safety Study of GP/FP Regimens in Advanced Nasopharyngeal Carcinoma

A Randomized, Multicenter Phase III Clinical Trial Comparing Gemcitabine and Cisplatin With 5-Fluorouracil and Cisplatin in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer	NCT01365208	Advanced Nasoph...	Chemotherapy	18 Years -	Chinese University of Hong Kong
GP-induced Chemotherapy Combined With IMRT and TPF-induced Chemotherapy Combined With IMRT in the Treatment of Distant Metastatic Nasopharyngeal Carcinoma	NCT03723343	Advanced Nasoph...	GP+IMRT TPF+IMRT	18 Years - 65 Years	Guiyang Medical University
New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer	NCT01365208	Advanced Nasoph...	Chemotherapy	18 Years -	Chinese University of Hong Kong
SBRT Combined With Chemotherapy and Tislelizumab in Metastatic NPC	NCT05652192	Advanced Nasoph...	SBRT	18 Years - 75 Years	Zhejiang Cancer Hospital
GP-induced Chemotherapy Combined With IMRT and TPF-induced Chemotherapy Combined With IMRT in the Treatment of Distant Metastatic Nasopharyngeal Carcinoma	NCT03723343	Advanced Nasoph...	GP+IMRT TPF+IMRT	18 Years - 65 Years	Guiyang Medical University
Dose-finding Study of Abraxane in Combination With Cisplatin to Treat Advanced Nasopharyngeal Carcinoma	NCT01735409	Nasopharyngeal ...	ABX + DDP ABX + DDP ABX + DDP	18 Years -	Sun Yat-sen University
SBRT Combined With Chemotherapy and Tislelizumab in Metastatic NPC	NCT05652192	Advanced Nasoph...	SBRT	18 Years - 75 Years	Zhejiang Cancer Hospital
Effect and Safety Study of GP/FP Regimens in Advanced Nasopharyngeal Carcinoma	NCT01528618	Nasopharyngeal ...	gemcitabine and... 5-Fluorouracil ...	18 Years -	Sun Yat-sen University
New Approach of Assessing Drug Response for Treatment of Nasopharyngeal Cancer	NCT01365208	Advanced Nasoph...	Chemotherapy	18 Years -	Chinese University of Hong Kong

Spots Global Cancer Trial Database for advanced nasopharyngeal carcinoma