Endostatin in Combination With Chemotherapy for Metastatic Nasopharyngeal Carcinoma

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A Study of a PD-1/CTLA-4 Bispecific Antibody AK104 in Patients With Metastatic Nasopharyngeal Carcinoma Study of LMP1- and LMP2- Specific Cytotoxic T-Lymphocytes (CTL) Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage Nimotuzumab Combined With VMAT in Elderly Patients With Nasopharyngeal Carcinoma Bintrafusp Alfa in Previously Treated Patients With Recurrent and Metastatic (R/M) Non-keratinizing Nasopharyngeal Carcinoma (NPC) Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma Weekly Plasma EBV DNA for Non-metastatic Nasopharyngeal Carcinoma Carboplatin and Docetaxel Followed by Epstein-Barr Virus Cytotoxic T Lymphocytes Intensity-modulated Radiation Therapy Combined With Cisplatin or Nedaplatin Chemotherapy in Nasopharyngeal Carcinoma MK-2206 in Recurrent Nasopharyngeal Carcinoma Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma Prospective Comparisons of Clinical Trial and Real-world Outcomes in Nasopharyngeal Carcinoma Serial Plasma EBV DNA for Nasopharyngeal Carcinoma Apatinib in Treating Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Induction Chemotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study for the Treatment of N2-3 Nasopharyngeal Carcinoma Patients Phase 2 Trial of Ipilimumab and Nivolumab in Nasopharyngeal Carcinoma A Trial On 4 Cycles Of Neoadjuvant Chemotherapy Plus Concurrent Chemoradiation In N2-3 Nasopharyngeal Carcinoma Effect of Oral Supplements on the Nutritional Status of Locally Advanced Nasopharyngeal Carcinoma Patients Endostar for Locally Recurrent Nasopharyngeal Carcinoma Prospective Study for Prognostic Biomarkers of Nasopharyngeal Carcinoma A Phase II Study of Icotinib in Treating Patients With Advanced Nasopharyngeal Carcinoma Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) for Locally Recurrent Nasopharyngeal Carcinoma Intestinal Flora Sequencing for Nasopharyngeal Carcinoma Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy Molecular Genetics Study of Nasopharyngeal Carcinoma: Characterization of NCP Susceptibility Gene(s) Induction Chemotherapy of TPX in Nomogram-predicted High Risk Locoregionally Advanced Nasopharyngeal Carcinoma Apatinib Combined With PD-1 in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma Induction Chemotherapy With GP Versus TPF in the Treatment of Advanced Nasopharyngeal Carcinoma Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma Induction Chemotherapy With Nab-paclitaxel, Cisplatin and Fluorouracil for Locoregionally Advanced Nasopharyngeal Carcinoma Phase III Study of Camrelizumab in Combination With Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma Docetaxal & Cisplatin vs LDFRT + Docetaxal & Cisplatin in Locally Advanced NPC Aspirin Improve Survival of N2-3 Nasopharyngeal Carcinoma Patients GC Regimen Chemotherapy Plus CIK Cells for Metastatic Nasopharyngeal Carcinoma A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients A Phase III Study of Radiotherapy With or Without Adjuvant C/T in Advanced Stage Nasopharyngeal Carcinoma Patients The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma Induction Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma Trail Evaluating Carbon Ion Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma The Value of Single-cycle TPF Induction Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma Effect of Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Locoregionally Advanced,Low-risk Nasopharyngeal Carcinoma Endostar Combined With Induction Chemotherapy and Concurrent Chemoradiotherapy for Locoregional Nasopharyngeal Carcinoma Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma Induction Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma A Study of Anti-PD-1 AK105 in Patients With Metastatic Nasopharyngeal Carcinoma Induction Gemcitabine and Cisplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma Hypofractionated Versus Conventionally Fractionated Radiotherapy for Initial Distant Metastases Nasopharyngeal Carcinoma Foscan®-Mediated Photodynamic Therapy Versus Brachytherapy in Patients With Nasopharyngeal Carcinoma The Influence of Anxiety and Depression on Survival in Nasopharyngeal Carcinoma Patients A Multicenter Trial Evaluating the Efficacy of Nedaplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma Concurrent Chemoradiotherapy With Nimotuzumab for High Risk Nasopharyngeal Carcinoma Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT Reduced-dose Radiotherapy for Low-risk Stage III Patients With Nasopharyngeal Carcinoma Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma Post-treatment Ultrasensitive Positron Emission Tomography in Nasopharyngeal Carcinoma Patients Single-agent Capecitabine as Adjuvant Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma Late Sequelae of Childhood and Adolescent Nasopharyngeal Carcinoma Survivors After Radiotherapy Photon/Proton Radiation Therapy for Carcinoma of the Nasopharynx Chemotherapy Plus Subsequent Loco-regional Radiotherapy Combined With Toripalimab in the De Novo Metastatic Nasopharyngeal Carcinoma The Role of Concurrent Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma(NPC) in the Era of IMRT Chemotherapy Combined With Radiotherapy vs Chemotherapy Alone for Distant Metastatic Nasopharyngeal Carcinoma LMP1- and LMP2-Specific CTLs to Patients With EBV-Positive NPC (NATELLA) Hippocampus Avoidance During Intensity Modulated Radiotherapy for T4 Nasopharyngeal Carcinoma Patients Endostar Combined With Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma Administration of Epstein Barr Virus – Specific Cytotoxic T-Lymphocytes to Metastatic EBV-Positive Nasopharygneal Cancer Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma Effect of the Plasma EBV DNA Change During Chemoradiotherapy in Nasopharyngeal Carcinoma Reduced Target Delineation and Radiation Doses Chemoradiotherapy for Patients With Locoregionally Advanced Nasopharyngeal 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Brief Title

Endostatin in Combination With Chemotherapy for Metastatic Nasopharyngeal Carcinoma

Official Title

A Prospective,Randomized,Controlled,Multicenter,Phase III Study of Stage Ⅲ Study of Gemcitabine Plus Cisplatin With or Without Endostatin to the Metastatic Nasopharyngeal Carcinoma

Brief Summary

      The investigators designed this study to evaluate the efficiency and the acute toxicities of
      recombinant human endostatin (endostar) combined with chemotherapy in the metastatic
      nasopharyngeal carcinoma (NPC).

Detailed Description

      To evaluate the progression free survival (PFS), overall survival (OS), Acute adverse
      reaction of recombinant human endostatin (endostar) combined with chemotherapy to the
      metastatic nasopharyngeal carcinoma (NPC).

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

progress free survival(PFS)

Secondary Outcome

 overall survival(OS)

Condition

Effects of Chemotherapy

Intervention

Recombinant Human Endostatin plus gemcitabine and cisplatin

Study Arms / Comparison Groups

 EGP group
Description:  the group of participants who undergoing Recombinant Human Endostatin plus Gemcitabine and cisplatin chemotherapy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

362

Start Date

August 2013

Completion Date

December 2016

Primary Completion Date

January 2016

Eligibility Criteria

        Inclusion Criteria:

          -  metastatic nasopharyngeal carcinoma 6 months after first treatment,never receive any
             anticancer treatment except local radiotherapy to the bone metastasis，at least one
             measurable metastatic lesions，ECOG PS 0-1，Electrocardiogram (ecg) no special
             abnormal，comply with the test requirements, cooperate with regular follow-up.

        Exclusion Criteria:

          -  To give local treatment,clinical severe infection(>grade 2),with the central nervous
             system metastases,ECOG PS≥2,patients with pregnancy or breastfeeding,has a history of
             peripheral nerve disease,concomitant with other serious diseases,ever or concomitant
             with other serious diseases except for Cervical carcinoma in situ,cure of basal cell
             carcinoma,bladder surface tumor,any cancer 3 years after curation.

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Xiaozhong Chen, 86-571-88122098, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT01915134

Organization ID

ZhejaingCH-npc-03

Responsible Party

Sponsor

Study Sponsor

Zhejiang Cancer Hospital

Collaborators

 Zhejiang University

Study Sponsor

Xiaozhong Chen, Principal Investigator, Zhejiang Cancer Hospital

Verification Date

July 2013