Camrelizumab Plus Stereotactic Body Radiotherapy vs Camrelizumab Alone For Oligometastatic Nasopharyngeal Carcinoma
NCT ID: NCT04944914
Last Updated: 2021-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
188 participants
INTERVENTIONAL
2021-06-01
2026-06-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Camrelizumab Plus Stereotactic Body Radiotherapy
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.
camrelizumab
Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks from 2 weeks before radiotherapy
stereotactic body radiotherapy
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.
Camrelizumab
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.
camrelizumab
Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks from 2 weeks before radiotherapy
Interventions
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camrelizumab
Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks from 2 weeks before radiotherapy
stereotactic body radiotherapy
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Affiliated Cancer Hospital & Institute of Guangzhou Medical University
OTHER
Zhongshan People's Hospital, Guangdong, China
OTHER
Guangdong Provincial People's Hospital
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Ming-Yuan Chen
professor & chief physician
Principal Investigators
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Ming-Yuan Chen, MD, PhD
Role: STUDY_CHAIR
Sun Yat-sen University
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Ming-Yuan Chen, MD, PhD
Role: primary
Other Identifiers
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SYSUCC-CMY-2021-
Identifier Type: -
Identifier Source: org_study_id