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

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Capecitabine

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

TPC induction chemotherapy regimen followed by concurrent chemoraditherapy (cisplatin 100 mg/m2, every 3 weeks for 3 cycles) and IMRT (PTVnx 70Gy/33f; PTVnd 70Gy/33f; PTV1 60Gy/33f; PTV2 54Gy/33f)

GP induction chemotherapy regimen followed by concurrent chemoraditherapy (cisplatin 100 mg/m2, every 3 weeks for 3 cycles) and IMRT (PTVnx 70Gy/33f; PTVnd 70Gy/33f; PTV1 60Gy/33f; PTV2 54Gy/33f)

TPC induction chemotherapy regimen contains Polymeric micellar paclitaxel, which is a novel Cremophor EL-free, nanoparticle micellar formulation of paclitaxel, cisplatin and capecitabine. TPC induction chemotherapy regimen (polymeric micellar paclitaxel 200 mg/m2 D1, cisplatin 75 mg/m2 D1, capecitabine 1000 mg/m2/day D1-14, every 3 weeks for 3 cycles).

TPC induction chemotherapy

GP induction chemotherapy regimen (gemcitabine 1000 mg/m2 D1/8, cisplatin 80 mg/m2 D1, every 3 weeks for 3 cycles)

GP induction chemotherapy

Hai-Qiang Mai

Hai-Qiang Mai, MD,PhD

Weijun Zhang

Shoumin Bai

Jiancong Sun

Zhigang Liu

Ning Zhang

Yajie Liu, MD

Kunyu Yang

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.

TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma

TPC Versus GP Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma, a Multi-center Phase II Randomized Trial

Defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.

Defined as the time from random assignment to death from any cause.

Defined as the time from random assignment to the occurrence of a distant progression. Cumulative incidence of distant progression will be calculated within a competing risk framework (Fine and Gray 1999).

Defined as the time from random assignment to the occurrence of a locoregional progression. Cumulative incidence of locoregional progression will be calculated within a competing risk framework (Fine and Gray 1999).

Tumour response was classified according to RECIST, version 1.1

Incidence of acute toxicity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 5.0 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. Acute adverse events, occurring during study treatment, and radiation-related late adverse events, occurring from 3 months after completion of radiotherapy, and chemotherapy-induced late adverse events, occurring from 3 months after completion of chemotherapy until end of follow up).

Sun Yat-sen University

Professor

Symptoms and General Pathology

Recurrence

Disease Attributes

Antibodies

Immunoglobulins

Antibodies, Blocking

Immunologic Factors

Patients randomized to this arm will receive three cycles of PD-1 antibody (JS001, 240mg every three weeks) combined with GP chemotherapy, then receive IMRT and PD-1 antibody maintenance for eight cycles.

Patients randomized to this arm will receive three cycles of GP chemotherapy, then receive IMRT alone.

Toripalimab 240mg, D1, every 3 weeks per cycle

PD-1 blocking antibody

Gemcitabine 1.0g/m2, D1 and D8; Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles

IMRT

Jingjing Miao

Chong Zhao

Chong Zhao, M.D

Suqing Tian

Shun Lu

Shaojun Lin

Feng Jin

Xiaozhong Chen

Jingao Li

Rengshen Wang

Chaosu Hu

Conghua Xie

Mei Shi

Qin Lin

This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.

PD-1 Antibody Combined With Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients

PD-1 Antibody Combined With Chemoradiotheapy vs. Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients: a Multicenter, Randomised Controlled, Phase III Clinical Trial

From date of randomisation to disease progression

Evaluating with questionnaire of EuroQoL 5 dimension, 5 level health state utility index (EQ-5D-5L)

Prof.

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

PD-1 inhibitor plus GP chemotherapy as Neoadjuvant Therapy followed by IMRT combined with cisplatin concurrent chemotherapy

GP chemotherapy as Neoadjuvant Therapy chemotherapy followed by IMRT combined with cisplatin concurrent chemotherapy

PD-1 inhibitor (200-240mg), gemcitabine (1000mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1) every three weeks for three cycles as neoadjuvant therapy, then followed by IMRT and cisplatin (100mg/m2, d1, 22, 43 of RT) during concurrent chemoradiotherapy.

PD-1 inhibitor+GP

Gemcitabine (1000mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1) every three weeks for three cycles as neoadjuvant therapy, then followed by IMRT and cisplatin (100mg/m2, d1, 22, 43 of RT) during concurrent chemoradiotherapy.

KAI HU, MD

RENSHENG WANG, MD

The purpose of this Phase II, Multicenter, Randomized Controlled Clinical Trial is to evaluate the efficacy and safety of PD-1 inhibitor Plus GP chemotherapy as Neoadjuvant Therapy in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma.

Induction chemotherapy plus concurrent chemoradiotherapy has the IIA evidence and the gemcitabine plus cisplatin (GP) regimen has the I evidence in the National Comprehensive Cancer Network (NCCN) guidelines for the treatment of locoregionally advanced nasopharyngeal carcinoma (NPC). More and more evidence shows that immunotherapy combined with chemotherapy has a synergistic effect in treating tumors. GP chemotherapy combined with PD-1 inhibitor has achieved the initial effect in NPC. With the development of radiotherapeutic techniques and equipment as well as advances in treatment modalities, the 5-year overall survival of patients with non-disseminated NPC has exceeded 80%. But there are still about 20-30% of NPC patients who experienced recurrence or metastasis after radical chemoradiotherapy, especially locoregionally advanced patients. In order to improve their survival, we conduct this clinical trial to determine whether GP chemotherapy combined with PD-1 inhibitor as neoadjuvant therapy can improve the failure-free survival rate of locoregionally advanced NPC patients and provide new evidence for their neoadjuvant therapy of them.

PD-1 Inhibitor Plus GP as Neoadjuvant Therapy for Locoregionally Advanced Nasopharyngeal Carcinoma

PD-1 Inhibitor Plus GP Chemotherapy as Neoadjuvant Therapy for Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase II, Multicenter, Randomized Controlled Clinical Trial

the time from registration to treatment failure or death from any cause, whichever is first.

the complete disappearance of the target and non-target lesion identified at baseline after radiological evaluation by MRI. Disease response was evaluated after the completion of the neoadjuvant therapy, according to RECIST 1.1.

the time from registration to death due to any cause, or censored at date last known alive.

the time from registration to the first locoregional relapse or death from any cause.

the time from registration to the first distant metastasis or death from any cause.

Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) and immune-related AEs (irAEs), and all-grade AEs and grade 3-4 AEs. AEs are evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0

Assessed by European Organization for Research and Treatment of Cancer's quality of life questionnaire(QLQ)-C30

Afﬁliated Hospital of North Sichuan Medical College

Hainan People's Hospital

Wuzhou Red Cross Hospital

First People's Hospital of Yulin

Fourth Affiliated Hospital of Guangxi Medical University

Guigang People's Hospital

Wuhan Union Hospital, China

Yunnan Cancer Hospital

LiuZhou People's Hospital

Guangxi Medical University

professor

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Oculocerebral Syndrome With Hypopigmentation

Irinotecan

Antimetabolites

Gemcitabine (1250 mg/m2) IV on D 1, 8. Cisplatin (75 mg/m2) IV on D1 every 3 weeks.

Irinotecan (65 mg/m2) IV on day1 , 8 Cisplatin (30 mg/m2) IV on day 1 , 8 every 3 weeks

JI-YOUN HAN, M.D.

The primary objective of this randomized phase II study is to compare the Response Rate of each sequence of treatment approach in patients with advanced NSCLC. Additionally, development of gene expression profiles and genotypes that can predict response to commonly used chemotherapy may provide a unique opportunity to better utilize drugs shown to be effective in first- or second-line therapy. Here, the investigators will conduct a pharmacogenomic study to provide rational approach to the treatment of NSCLC by developing predictors of cisplatin (first-line agent) and pemetrexed or docetaxel (second-line agents) sensitivity and demonstrating the clinical value of identifying the most appropriate drug on the basis of sensitivity profile for the treatment regimen of each individual patient. Such an approach is likely to maximize response to chemotherapy and may change the current empirical paradigm of NSCLC therapy.

Cisplatin-based chemotherapy is currently considered to be the standard treatment in advanced non-small cell lung cancer (NSCLC). However, overall response is only 30-40%, suggesting that a majority of the patients do not respond to platinum. Subsequently, those patients who experience treatment failure with platinum-based therapy typically received pemetrexed or docetaxel as second-line treatment, with response rate of approximately 7% to 10%. The primary objective of this randomized phase II study is to compare the Response Rate of each sequence of treatment approach in patients with advanced NSCLC. Additionally, development of gene expression profiles and genotypes that can predict response to commonly used chemotherapy may provide a unique opportunity to better utilize drugs shown to be effective in first- or second-line therapy. Here, we will conduct a pharmacogenomic study to provide rational approach to the treatment of NSCLC by developing predictors of cisplatin (first-line agent) and pemetrexed or docetaxel (second-line agents) sensitivity and demonstrating the clinical value of identifying the most appropriate drug on the basis of sensitivity profile for the treatment regimen of each individual patient. Such an approach is likely to maximize response to chemotherapy and may change the current empirical paradigm of NSCLC therapy.

Pharmacogenomic Study for Providing Personalized Strategy to the Treatment of Non-small Cell Lung Cancer (NSCLC) IIIB/IV

Randomized phase2 Study of IP vs. GP as the First-line Therapy Followed by Two Different Sequences as the 2nd or 3rd-line Therapy for Patients With Advanced NSCLC;

as the period between the day of the treatment and the date of progression or death

from C1D1 to 30 days after the last dose administration

at baseline and time to disease progression

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma	NCT06301165	Nasopharyngeal ...	TPC induction c... GP induction ch...	18 Years - 65 Years	Sun Yat-sen University
PD-1 Antibody Combined With Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients	NCT03907826	Recurrent Nasop...	PD-1 blocking a... GP IMRT	18 Years - 70 Years	Sun Yat-sen University
PD-1 Inhibitor Plus GP as Neoadjuvant Therapy for Locoregionally Advanced Nasopharyngeal Carcinoma	NCT05340270	Nasopharyngeal ... Neoadjuvant The... PD-1 Inhibitor	PD-1 inhibitor+... GP	18 Years - 65 Years	Guangxi Medical University
Pharmacogenomic Study for Providing Personalized Strategy to the Treatment of Non-small Cell Lung Cancer (NSCLC) IIIB/IV	NCT01003964	Non Small Cell ...	IP GP	18 Years -	National Cancer Center, Korea
PD-1 Inhibitor Plus GP as Neoadjuvant Therapy for Locoregionally Advanced Nasopharyngeal Carcinoma	NCT05340270	Nasopharyngeal ... Neoadjuvant The... PD-1 Inhibitor	PD-1 inhibitor+... GP	18 Years - 65 Years	Guangxi Medical University
PD-1 Inhibitor Plus GP as Neoadjuvant Therapy for Locoregionally Advanced Nasopharyngeal Carcinoma	NCT05340270	Nasopharyngeal ... Neoadjuvant The... PD-1 Inhibitor	PD-1 inhibitor+... GP	18 Years - 65 Years	Guangxi Medical University

Spots Global Cancer Trial Database for gp

Every month we try and update this database with for gp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gp

Every month we try and update this database with for gp cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gp cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.