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Combining RT With Toripalimab and Chemotherapy in Metastatic Nasopharyngeal Carcinoma

Primary Purpose

Metastatic Nasopharyngeal Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Radiotherapy
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Nasopharyngeal Cancer focused on measuring Metastatic Nasopharyngeal Cancer, PD-1, Radiotherapy, Chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age:18-75 years, male or female.
  • ECOG 0-2
  • Histologically or cytologically confirmed de novo metastatic nasopharyngeal carcinoma.(stage IVb, AJCC 8th)
  • Complete response or partial response after at least 3 cycles (no more than 6 cycles) of Gemcitabine plus cisplatin combined with Toripalimab
  • Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
  • Adequate organ function.
  • Patient has given written informed consent.

Exclusion Criteria:

  • Unwilling or unable to provide informed consent
  • Intolerance to radiotherapy or immunotherapy
  • Patients who have head and neck radiotherapy history.
  • previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
  • women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
  • in other clinical trials within 30 days
  • Patients with autoimmune disorder, including but not limited to systemic lupus erythematosus or multiple sclerosis;
  • History of primary immunodeficiency
  • History of active tuberculosis, drug-induced interstitial lung disease, or ≥ Grade 2 pulmonitis;
  • Patients with human immunodeficiency virus (HIV) positive;
  • Comorbidities that cannot be controlled by concomitant treatment, including but not limited to: ongoing or active infection, unexplained fever > 38.5°C (subjects with neoplastic fever are judged by the investigator to be included), symptomatic congestive heart failure ≥ Grade 2 according to New York Heart Association (NYHA) functional classification, LVEF (left ventricular ejection fraction) < 50%, hypertension poorly controlled by drugs, unstable angina, arrhythmia, active peptic ulcer disease or gastritis;
  • not suitable for this study judged by researchers

Sites / Locations

  • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RT group

Arm Description

Outcomes

Primary Outcome Measures

Progression free survival (PFS)

Secondary Outcome Measures

Overall survival (OS)
Objective response rate (ORR)
Local-regional free survival (LRFS)
Distant metastasis free survival (DMFS)
Treatment-emergent adverse events
Incidence of treatment-emergent adverse events would be assessed based on the common toxicity criteria for adverse events version 5.0 (CTCAE v5.0)

Full Information

First Posted
May 14, 2022
Last Updated
May 21, 2022
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05385926
Brief Title
Combining RT With Toripalimab and Chemotherapy in Metastatic Nasopharyngeal Carcinoma
Official Title
A Phase II Study: Safety and Efficacy of Combining Radiation Therapy With Toripalimab and Chemotherapy in de Novo Metastatic Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

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
Incidences of de novo metastatic nasopharyngeal carcinoma range from 6% to 8% at the time of presentation. For the initial diagnosis of metastatic NPC, PD-1 plus chemotherapy yields a satisfactory outcome with1year PFS of 40%. Previous study demonstrated the benefit of adding radiotherapy to chemotherapy in metastatic NPC, however there is no evidence whether radiotherapy can further improve PFS based on chemotherapy plus PD-1 . The purpose of this study is to evaluate the safety and effectiveness of first-line immunochemotherapy combined with radiotherapy for initial diagnosed metastatic NPC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Nasopharyngeal Cancer
Keywords
Metastatic Nasopharyngeal Cancer, PD-1, Radiotherapy, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RT group
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
Patients who had complete response or partial response after at least 3 cycles (no more than 6 cycles) of Gemcitabine plus cisplatin combined with Toripalimab receive local radiotherapy 21 days. For those non-CR oligo-metastatic disease or symptomatic lesion, SBRT or conventional RT delivered. Maintenance therapy of Toripalimab for 2 years.
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Time Frame
1year
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
1year
Title
Objective response rate (ORR)
Time Frame
4-8 weeks
Title
Local-regional free survival (LRFS)
Time Frame
1 year
Title
Distant metastasis free survival (DMFS)
Time Frame
1 year
Title
Treatment-emergent adverse events
Description
Incidence of treatment-emergent adverse events would be assessed based on the common toxicity criteria for adverse events version 5.0 (CTCAE v5.0)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age:18-75 years, male or female. ECOG 0-2 Histologically or cytologically confirmed de novo metastatic nasopharyngeal carcinoma.(stage IVb, AJCC 8th) Complete response or partial response after at least 3 cycles (no more than 6 cycles) of Gemcitabine plus cisplatin combined with Toripalimab Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Adequate organ function. Patient has given written informed consent. Exclusion Criteria: Unwilling or unable to provide informed consent Intolerance to radiotherapy or immunotherapy Patients who have head and neck radiotherapy history. previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose in other clinical trials within 30 days Patients with autoimmune disorder, including but not limited to systemic lupus erythematosus or multiple sclerosis; History of primary immunodeficiency History of active tuberculosis, drug-induced interstitial lung disease, or ≥ Grade 2 pulmonitis; Patients with human immunodeficiency virus (HIV) positive; Comorbidities that cannot be controlled by concomitant treatment, including but not limited to: ongoing or active infection, unexplained fever > 38.5°C (subjects with neoplastic fever are judged by the investigator to be included), symptomatic congestive heart failure ≥ Grade 2 according to New York Heart Association (NYHA) functional classification, LVEF (left ventricular ejection fraction) < 50%, hypertension poorly controlled by drugs, unstable angina, arrhythmia, active peptic ulcer disease or gastritis; not suitable for this study judged by researchers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Ma, MD
Phone
+8675566618168
Email
ml_1990@126.com
Facility Information:
Facility Name
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Shenzhen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Ma, MD
Phone
+8675566618168
Email
ml_1990@126.com
First Name & Middle Initial & Last Name & Degree
Runye Wu, PhD
First Name & Middle Initial & Last Name & Degree
Li Ma, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Combining RT With Toripalimab and Chemotherapy in Metastatic Nasopharyngeal Carcinoma

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