Concurrent Chemoradiotherapy With Toripalimab for Local-regional Recurrent Nasopharyngeal Carcinoma: a Prospective, Single-arm, Phase II Trial
NCT ID: NCT04992988
Last Updated: 2021-08-20
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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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2020-06-28
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Toripalimab+CCRT
Cisplatin 100mg/m2(every three weeks),D1,D22,D43 of intensity modulated radiotherapy.
Toripalimab 240mg every 3 weeks with a total of 3 cycles as concurrent anti-PD-1 immunotherapy; Toripalimab240mg every 3 weeks with a total of 9 cycles as adjuvant anti-PD-1 immunotherapy 3 weeks after CCRT
Toripalimab
Toripalimab 240mg every 3 weeks with a total of 3 cycles as concurrent anti-PD-1 immunotherapy; Toripalimab240mg every 3 weeks with a total of 9 cycles as adjuvant anti-PD-1 immunotherapy 2 weeks after CCRT
Interventions
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Toripalimab
Toripalimab 240mg every 3 weeks with a total of 3 cycles as concurrent anti-PD-1 immunotherapy; Toripalimab240mg every 3 weeks with a total of 9 cycles as adjuvant anti-PD-1 immunotherapy 2 weeks after CCRT
Eligibility Criteria
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Inclusion Criteria
2. staged as rT3-4N0-1M0或rT1-4N2-3M0 （according to the 8th AJCC edition）
3. Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
4. Neutrophil ≥ 1.5×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
5. With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 1.5×ULN)
6. With normal renal function test ( creatinine clearance ≥60 ml/min)
7. sign an "informed consent form
8. Male and no pregnant female
Exclusion Criteria
2. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥200IU/ml, or 1000cps/ml.
3. Patients with positive HCV antibody.
4. Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, and skin disease (leukoderma, psoriasis, alopecia et al) who don't need systemic therapy can recruit.
5. History of interstitial lung disease
6. Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent.
7. Receive or will receive live vaccine within 30 days prior to signing the informed consent.
8. Women of child-bearing potential who are pregnant or breastfeeding.
9. Suffered from malignant tumors, except the carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years.
10. Hypersensitivity to macromolecular protein, or to any component of triplezumab.
11. HIV positive.
12. Severe, uncontrolled medical conditions and infections.
13. Other diseases which may influence the safety or compliance of the clinical trial, such as heart failure with symptom, unstable angina, myocardial infarction, active infections those need systemic therapy, mental illness, or their family and society factors.
18 Years
70 Years
ALL
No
Sponsors
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Cancer Hospital of Guangxi Medical University
OTHER
Responsible Party
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Song Qu
Principal Investigator
Locations
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Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Countries
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Facility Contacts
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References
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Other Identifiers
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KY2020163
Identifier Type: -
Identifier Source: org_study_id
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