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Camrelizumab Plus Stereotactic Body Radiotherapy vs Camrelizumab Alone For Oligometastatic Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
camrelizumab
stereotactic body radiotherapy
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 Oligometastatic Nasopharyngeal Carcinoma, Immunotherapy, Stereotactic Body Radiotherapy

Eligibility Criteria

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

Inclusion Criteria:

  1. Male or female; 18-70 years of age.
  2. Primary lesion and regional lymph nodes completed radical radiotherapy 3 months before stereotactic body radiotherapy and diseases well controlled.
  3. Underwent at least first-line systemic chemotherapy, regardless of regimen and curative effect.
  4. Imageological evidence for oligometastatic lesions (metastatic tissue biopsy preferred but not necessary). The number of total metastatic lesions no more than 5 and the number of metastatic lesions within a single organ no more than 3.
  5. ECOG performance status of 0 or 1.
  6. Stereotactic body radiotherapy applicable for all metastatic lesions according to MDT.
  7. If metastatic lesions have received local treatment (surgery, radiofrequency ablation, radiotherapy etc.):

    • Eligible if treated lesion is well controlled according to imageological examinations, and the lesion does not need stereotactic body radiotherapy.
    • If treated lesion is not controlled according to imageological examinations:

      • Eligible if the treatment is surgery and that stereotactic body radiotherapy is applicable for the treated lesion.
      • Ineligible if the treatment is radiofrequency ablation or radiotherapy.
  8. Maximum diameter of brain metastatic lesion no more than 3cm.
  9. Maximum diameter of metastatic lesion (brain excluded) no more than 5cm.

    • Maximum diameter of bone metastatic lesion no more than 6cm if attending doctor decides it is safe to apply the treatment.
  10. Life expectancy more than 12 weeks.

Exclusion Criteria:

  1. Immunotherapy (PD-1/PD-L1 or CTLA-4 monoclonal antibody) failure.
  2. CHD no less than grade 2, arrhythmia (QTc interval over 450ms for male and 470ms for female) or cardiac insufficiency.
  3. History of severe hypersensitivity to any ingredient of PD-1/PD-L1 or other monoclonal antibody.
  4. chemotherapy (cytotoxic or molecular targeted) within 4 weeks before stereotactic body radiotherapy.
  5. Imageological evidence for spinal cord compression, or tumor less than 3mm away from spinal cord.
  6. Patient with brain metastasis who needs decompression surgery.
  7. Other malignancy or malignant hydrothorax.
  8. Concurrent known or suspicious autoimmune disease, including dementia and epilepsy.
  9. Use of large dose corticosteroids within 4 weeks before study drug administration.
  10. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids.
  11. Active tuberculosis (TB), anti-TB treatment is ongoing or within 1 year prior to screening
  12. Subjects with any active autoimmune disease or history of autoimmune disease, or history of syndrome that requires systemic steroids or immunosuppressive medications, including but not limited to the following: rheumatoid arthritis, pneumonitis, colitis (inflammatory bowel disease), hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy.
  13. 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.
  14. Received any anti-infective vaccine (e.g. influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment.
  15. Pregnancy or lactation.
  16. Other ineligible patients according to attending doctor.

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Camrelizumab Plus Stereotactic Body Radiotherapy

Camrelizumab

Arm Description

Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks from 2 weeks before radiotherapy, and then receive stereotactic body radiotherapy until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision or the upper limit of treatment duration of 1 year.

Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision or the upper limit of treatment duration of 1 year.

Outcomes

Primary Outcome Measures

Median progression-free survival (PFS)
Progression-free survival is calculated from the date of randomization to the date of death of any cause or the first progress at any site, censored on the last date of tumor evaluation if no progress has happened.

Secondary Outcome Measures

Objective response rate (ORR)
Objective response rate is the rate of patients achieving complete response or partial response for a certain period of time after intervention.
Disease control rate (DCR)
Disease control rate is the rate of patients achieving complete response, partial response or stable disease for at least 4 weeks after intervention.
Clinical benefit rate (CBR)
Clinical benefit rate is the rate of patients achieving complete response, partial response or stable disease for at least 6 months after intervention.
Median overall survival (OS)
Overall survival is calculated from the date of randomization to the date of death of any cause, censored on the last date of known survival if no death has happened.
Adverse events
NCI-CTC5.0 and RTOG standards are adopted, and acute subjective toxicity, acute objective toxicity and late subjective toxicity are included.
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
June 28, 2021
Last Updated
June 28, 2021
Sponsor
Sun Yat-sen University
Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Zhongshan People's Hospital, Guangdong, China, Guangdong Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04944914
Brief Title
Camrelizumab Plus Stereotactic Body Radiotherapy vs Camrelizumab Alone For Oligometastatic Nasopharyngeal Carcinoma
Official Title
Camrelizumab Plus Stereotactic Body Radiotherapy vs Camrelizumab Alone For Oligometastatic Nasopharyngeal Carcinoma: A Multicenter Randomized Clinical Phase 3 Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Zhongshan People's Hospital, Guangdong, China, Guangdong Provincial People's Hospital

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
We intend to compare the efficacy and safety of immunotherapy plus stereotactic body radiotherapy at oligometastatic lesions and immunotherapy alone among patients with oligometastatic nasopharyngeal carcinoma whose primary lesion has been well controlled after radical local-regional treatment through this multicenter randomized phase 3 trial.
Detailed Description
We intend to apply camrelizumab plus stereotactic body radiotherapy at oligometastatic lesions to patients with oligometastatic nasopharyngeal carcinoma whose primary lesion has been well controlled after radical treatment through this multicenter randomized phase 3 trial to investigate whether stereotactic body radiotherapy at oligometastatic lesions on the basis of immunotherapy can achieve clinical cure among a part of patients with distant metastasis and improve their overall survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Oligometastatic Nasopharyngeal Carcinoma, Immunotherapy, Stereotactic Body Radiotherapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Camrelizumab Plus Stereotactic Body Radiotherapy
Arm Type
Experimental
Arm Description
Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks from 2 weeks before radiotherapy, and then receive stereotactic body radiotherapy until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision or the upper limit of treatment duration of 1 year.
Arm Title
Camrelizumab
Arm Type
Active Comparator
Arm Description
Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision or the upper limit of treatment duration of 1 year.
Intervention Type
Drug
Intervention Name(s)
camrelizumab
Intervention Description
Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks from 2 weeks before radiotherapy
Intervention Type
Radiation
Intervention Name(s)
stereotactic body radiotherapy
Other Intervention Name(s)
SBRT
Intervention Description
Patients receive stereotactic body radiotherapy for all oligometastatic lesions as radical therapy to control the disease and reduce any potential adverse impact to living quality. The dosage is based on published clinical studies.
Primary Outcome Measure Information:
Title
Median progression-free survival (PFS)
Description
Progression-free survival is calculated from the date of randomization to the date of death of any cause or the first progress at any site, censored on the last date of tumor evaluation if no progress has happened.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Objective response rate is the rate of patients achieving complete response or partial response for a certain period of time after intervention.
Time Frame
2 years
Title
Disease control rate (DCR)
Description
Disease control rate is the rate of patients achieving complete response, partial response or stable disease for at least 4 weeks after intervention.
Time Frame
2 years
Title
Clinical benefit rate (CBR)
Description
Clinical benefit rate is the rate of patients achieving complete response, partial response or stable disease for at least 6 months after intervention.
Time Frame
2 years
Title
Median overall survival (OS)
Description
Overall survival is calculated from the date of randomization to the date of death of any cause, censored on the last date of known survival if no death has happened.
Time Frame
2 years
Title
Adverse events
Description
NCI-CTC5.0 and RTOG standards are adopted, and acute subjective toxicity, acute objective toxicity and late subjective toxicity are included.
Time Frame
2 year
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
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
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: Male or female; 18-70 years of age. Primary lesion and regional lymph nodes completed radical radiotherapy 3 months before stereotactic body radiotherapy and diseases well controlled. Underwent at least first-line systemic chemotherapy, regardless of regimen and curative effect. Imageological evidence for oligometastatic lesions (metastatic tissue biopsy preferred but not necessary). The number of total metastatic lesions no more than 5 and the number of metastatic lesions within a single organ no more than 3. ECOG performance status of 0 or 1. Stereotactic body radiotherapy applicable for all metastatic lesions according to MDT. If metastatic lesions have received local treatment (surgery, radiofrequency ablation, radiotherapy etc.): Eligible if treated lesion is well controlled according to imageological examinations, and the lesion does not need stereotactic body radiotherapy. If treated lesion is not controlled according to imageological examinations: Eligible if the treatment is surgery and that stereotactic body radiotherapy is applicable for the treated lesion. Ineligible if the treatment is radiofrequency ablation or radiotherapy. Maximum diameter of brain metastatic lesion no more than 3cm. Maximum diameter of metastatic lesion (brain excluded) no more than 5cm. Maximum diameter of bone metastatic lesion no more than 6cm if attending doctor decides it is safe to apply the treatment. Life expectancy more than 12 weeks. Exclusion Criteria: Immunotherapy (PD-1/PD-L1 or CTLA-4 monoclonal antibody) failure. CHD no less than grade 2, arrhythmia (QTc interval over 450ms for male and 470ms for female) or cardiac insufficiency. History of severe hypersensitivity to any ingredient of PD-1/PD-L1 or other monoclonal antibody. chemotherapy (cytotoxic or molecular targeted) within 4 weeks before stereotactic body radiotherapy. Imageological evidence for spinal cord compression, or tumor less than 3mm away from spinal cord. Patient with brain metastasis who needs decompression surgery. Other malignancy or malignant hydrothorax. Concurrent known or suspicious autoimmune disease, including dementia and epilepsy. Use of large dose corticosteroids within 4 weeks before study drug administration. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Active tuberculosis (TB), anti-TB treatment is ongoing or within 1 year prior to screening Subjects with any active autoimmune disease or history of autoimmune disease, or history of syndrome that requires systemic steroids or immunosuppressive medications, including but not limited to the following: rheumatoid arthritis, pneumonitis, colitis (inflammatory bowel disease), hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. 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. Received any anti-infective vaccine (e.g. influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment. Pregnancy or lactation. Other ineligible patients according to attending doctor.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Yuan Chen, MD, PhD
Phone
86-20-8734-3361
Email
chmingy@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Rui You, MD, PhD
Phone
86-13580439820
Email
yourui@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
Study Chair
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
First Name & Middle Initial & Last Name & Degree
Ming-Yuan Chen, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Camrelizumab Plus Stereotactic Body Radiotherapy vs Camrelizumab Alone For Oligometastatic Nasopharyngeal Carcinoma

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