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Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma, PD-1, Surgery

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Toripalimab
salvage surgery
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal carcinoma, Recurrent, Salvage surgery, Anti-programmed death-1 antibody, Disease free survival

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting
  • The First Affiliated Hospital, Sun Yat-Sen University
  • Nanfang Hospital of Southern Medical University
  • The Fifth Affiliated Hospital of Guangzhou Medical University
  • The First People's Hospital of Foshan
  • Zhongshan People's Hospital
  • The Tenth Affiliated Hospital, Sun Yat-Sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Toripalimab plus salvage surgery

Salvage surgery alone

Arm Description

Toripalimab: Toripalimab treatment before and after salvage surgery. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node.

1. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node.

Outcomes

Primary Outcome Measures

Disease-free survival
Defined as the time interval from randomization to disease progression or death due to any cause, whichever come first.

Secondary Outcome Measures

Objective Response Rate
Defined as the proportion of patients with radiologically confirmed complete or partial response according to RECIST 1.1.
Major Pathological Response Rate
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.
Overall Survival
Defined as the time interval from randomization to death due to any cause.
Distant Metastasis-Free Survival
Defined as the time interval from randomisation to the date of first distant metastases.
Locoregional Relapse-Free Survival
Defined as the time from randomisation to the date of first locoregional relapse.
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
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.

Full Information

First Posted
February 25, 2021
Last Updated
March 3, 2021
Sponsor
Sun Yat-sen University
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, First People's Hospital of Foshan, Zhongshan People's Hospital, Guangdong, China, Tenth Affiliated Hospital, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04778956
Brief Title
Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma
Official Title
Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma: a Prospecitve, Parallel, Multicenter, Phase III, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
March 3, 2025 (Anticipated)
Study Completion Date
March 3, 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, First People's Hospital of Foshan, Zhongshan People's Hospital, Guangdong, China, Tenth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma, PD-1, Surgery
Keywords
Nasopharyngeal carcinoma, Recurrent, Salvage surgery, Anti-programmed death-1 antibody, Disease free survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Toripalimab plus salvage surgery
Arm Type
Experimental
Arm Description
Toripalimab: Toripalimab treatment before and after salvage surgery. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node.
Arm Title
Salvage surgery alone
Arm Type
Active Comparator
Arm Description
1. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node.
Intervention Type
Drug
Intervention Name(s)
Toripalimab
Other Intervention Name(s)
PD-1 antibody
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
salvage surgery
Intervention Description
Endoscopic nasopharyngectomy is used for recurrent nasopharyngeal tumor and selective neck dissection for recurrent regional lymph node.
Primary Outcome Measure Information:
Title
Disease-free survival
Description
Defined as the time interval from randomization to disease progression or death due to any cause, whichever come first.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
Defined as the proportion of patients with radiologically confirmed complete or partial response according to RECIST 1.1.
Time Frame
3-5 weeks
Title
Major Pathological Response Rate
Description
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.
Time Frame
4-6 weeks
Title
Overall Survival
Description
Defined as the time interval from randomization to death due to any cause.
Time Frame
2 years
Title
Distant Metastasis-Free Survival
Description
Defined as the time interval from randomisation to the date of first distant metastases.
Time Frame
2 years
Title
Locoregional Relapse-Free Survival
Description
Defined as the time from randomisation to the date of first locoregional relapse.
Time Frame
2 years
Title
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Description
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
Time Frame
up to 2 years
Title
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Description
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.
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The recurrence time is more than 6 months from the end of radiotherapy. Histologically confirmed recurrent nasopharyngeal carcinoma. 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) 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) Given written informed consent. Exclusion Criteria: Karnofsky Performance Status (KPS) ≤70. Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness. Has known subjects with other malignant tumors. Has participated in other drug trials within 3 months of planned start of study treatment. Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment. Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) agent. 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. 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. Has received a live vaccine within 4 weeks of planned start of study treatment. Pregnancy or breast feeding. Cannot complete regular follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Yuan Chen, MD, PhD
Phone
86-20-87343624
Email
chmingy@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
You-Ping Liu, MD, PhD
Phone
86-20-87343379
Email
liuyoup@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Yuan Chen, MD, PhD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming-Yuan Chen, MD, PhD
Phone
86-20-8734-3624
Email
chmingy@mail.sysu.edu.cn
Facility Name
The First Affiliated Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei-Ping Wen, MD, PhD
Phone
86-13802966937
Email
wenwp@mail.sysu.edu.cn
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao-Cheng Tang, MD.PhD
Phone
86-15920115552
Email
hctang2006@qq.com
Facility Name
The Fifth Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510700
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian-Zhong Zhang, MD
Phone
86-15820279737
Email
525567166@qq.com
Facility Name
The First People's Hospital of Foshan
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Tang, MD
Phone
86-18038860199
Email
tjun@fsyyy.com
Facility Name
Zhongshan People's Hospital
City
Zhongshan
State/Province
Guangdong
ZIP/Postal Code
528403
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min-Yi Fu
Phone
86-13924933366
Email
503498362@qq.com
Facility Name
The Tenth Affiliated Hospital, Sun Yat-Sen University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330008
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming-Yuan Chen, MD, PhD
Phone
86-13903052650
Email
chmingy@mail.sysu.edu.cn

12. IPD Sharing Statement

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Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma

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