Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04778956
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : March 4, 2021
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Nanfang Hospital of Southern Medical University
First People's Hospital of Foshan
Zhongshan People's Hospital, Guangdong, China
Tenth Affiliated Hospital, Sun Yat-sen University
Information provided by (Responsible Party):
Ming-Yuan Chen, Sun Yat-sen University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with resectable locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma PD-1 Surgery Drug: Toripalimab Procedure: salvage surgery Phase 3

Detailed Description:
Through multicenter, open-label, randomised clinical trials, patients with resectable locally recurrent nasopharyngeal carcinoma are randomized into salvage surgery plus PD-1 treatment group and salvage surgery alone group. The efficacy and safety of patients between these two groups are compared.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma: a Prospecitve, Parallel, Multicenter, Phase III, Randomized Clinical Trial
Actual Study Start Date : March 3, 2021
Estimated Primary Completion Date : March 3, 2025
Estimated Study Completion Date : March 3, 2033

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Toripalimab plus salvage surgery
  1. Toripalimab: Toripalimab treatment before and after salvage surgery.
  2. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node.
 Drug: Toripalimab
Toripalimab: 240 mg, intravenous injection over 60 minutes (Q3W); Toripalimab should be completed for 2 cycles at 1-2 weeks before surgery, and continually applied since 1-2 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year.
Other Name: PD-1 antibody

Procedure: salvage surgery
Endoscopic nasopharyngectomy is used for recurrent nasopharyngeal tumor and selective neck dissection for recurrent regional lymph node.
Active Comparator: Salvage surgery alone
1. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node.
 Procedure: salvage surgery
Endoscopic nasopharyngectomy is used for recurrent nasopharyngeal tumor and selective neck dissection for recurrent regional lymph node.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 2 years ]
    Defined as the time interval from randomization to disease progression or death due to any cause, whichever come first.


Secondary Outcome Measures :
  1. Objective Response Rate [ Time Frame: 3-5 weeks ]
    Defined as the proportion of patients with radiologically confirmed complete or partial response according to RECIST 1.1.

  2. Major Pathological Response Rate [ Time Frame: 4-6 weeks ]
    Defined as the proportion of patients with no more than 10% viable tumor cells which is identified on routine hematoxylin and eosin staining within the recurrent nasopharyngeal tumor and/or regional lymph node after neoadjuvant PD-1 treatment.

  3. Overall Survival [ Time Frame: 2 years ]
    Defined as the time interval from randomization to death due to any cause.

  4. Distant Metastasis-Free Survival [ Time Frame: 2 years ]
    Defined as the time interval from randomisation to the date of first distant metastases.

  5. Locoregional Relapse-Free Survival [ Time Frame: 2 years ]
    Defined as the time from randomisation to the date of first locoregional relapse.

  6. Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) [ Time Frame: up to 2 years ]
    Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.

  7. Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) [ Time Frame: up to 2 years ]
    Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) before treatment, during treatment, after treatment.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The recurrence time is more than 6 months from the end of radiotherapy.
  2. Histologically confirmed recurrent nasopharyngeal carcinoma.
  3. Resectable nasopharyngeal diseases: recurrent T1 (the tumor is confined in nasopharynx, oropharynx and/or nasal cavity without parapharyngeal involvement); recurrent T2 (the tumor is confined in the superficial parapharyngeal spacer and is more than 0.5cm far from the internal carotid artery) and recurrent T3 (the tumor is confined in the base wall of the sphenoid sinus and is more than 0.5cm far from the internal carotid artery and cavernous sinus). (according to the 8th edition of American Joint Committee on Cancer (AJCC) staging system for nasopharyngeal carcinoma)
  4. Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement. (according to the 8th edition of AJCC staging system)
  5. Given written informed consent.

Exclusion Criteria:

  1. Karnofsky Performance Status (KPS) ≤70.
  2. Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness.
  3. Has known subjects with other malignant tumors.
  4. Has participated in other drug trials within 3 months of planned start of study treatment.
  5. Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.
  6. Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses.
  7. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) agent.
  8. Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.
  9. Has a known history of human immunodeficiency virus (HIV), has hepatitis B surface antigen (HBsAg) positive with hepatitis B virus (HBV) DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
  10. Has received a live vaccine within 4 weeks of planned start of study treatment.
  11. Pregnancy or breast feeding.
  12. Cannot complete regular follow-up.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04778956


Contacts
Layout table for location contacts
Contact: Ming-Yuan Chen, MD, PhD 86-20-87343624 chmingy@mail.sysu.edu.cn
Contact: You-Ping Liu, MD, PhD 86-20-87343379 liuyoup@sysucc.org.cn

Locations
Layout table for location information
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Ming-Yuan Chen, MD, PhD    86-20-8734-3624    chmingy@mail.sysu.edu.cn   
The First Affiliated Hospital, Sun Yat-Sen University Not yet recruiting
Guangzhou, Guangdong, China, 510080
Contact: Wei-Ping Wen, MD, PhD    86-13802966937    wenwp@mail.sysu.edu.cn   
Nanfang Hospital of Southern Medical University Not yet recruiting
Guangzhou, Guangdong, China, 510515
Contact: Hao-Cheng Tang, MD.PhD    86-15920115552    hctang2006@qq.com   
The Fifth Affiliated Hospital of Guangzhou Medical University Not yet recruiting
Guangzhou, Guangdong, China, 510700
Contact: Jian-Zhong Zhang, MD    86-15820279737    525567166@qq.com   
The First People's Hospital of Foshan Not yet recruiting
Guangzhou, Guangdong, China, 528000
Contact: Jun Tang, MD    86-18038860199    tjun@fsyyy.com   
Zhongshan People's Hospital Not yet recruiting
Zhongshan, Guangdong, China, 528403
Contact: Min-Yi Fu    86-13924933366    503498362@qq.com   
China, Jiangxi
The Tenth Affiliated Hospital, Sun Yat-Sen University Not yet recruiting
Nanchang, Jiangxi, China, 330008
Contact: Ming-Yuan Chen, MD, PhD    86-13903052650    chmingy@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-sen University
First Affiliated Hospital, Sun Yat-Sen University
Nanfang Hospital of Southern Medical University
First People's Hospital of Foshan
Zhongshan People's Hospital, Guangdong, China
Tenth Affiliated Hospital, Sun Yat-sen University
Investigators
Layout table for investigator information
Principal Investigator: Ming-Yuan Chen, MD, PhD Sun Yat-sen University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ming-Yuan Chen, Professor, Chief Doctor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04778956    
Other Study ID Numbers: SYSUCC-CMY-2020-2302
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ming-Yuan Chen, Sun Yat-sen University:
Nasopharyngeal carcinoma
Recurrent
Salvage surgery
Anti-programmed death-1 antibody
Disease free survival
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
 Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases