Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in HNSCC Patients
NCT ID: NCT04164238
Last Updated: 2019-11-15
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
90 participants
INTERVENTIONAL
2019-11-07
2021-11-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Toripalimab 240mg IV, every 3 weeks;
Toripalimab
Toripalimab Injection
Arm B
Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m\^2, IV, Q3W; Carboplatin AUC 5, IV, Q3W
Toripalimab
Toripalimab Injection
Paclitaxel
Paclitaxel Injection
Carboplatin
Carboplatin Injection
Arm C
Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m\^2, IV, Q3W; Cisplatin 25mg/m\^2 IV,d1-d3, Q3W; 5-FU 3000mg/m\^2 CIV 72h, Q3W
Toripalimab
Toripalimab Injection
Paclitaxel
Paclitaxel Injection
Cisplatin
Cisplatin injection
5-fu
5-fu injection
Interventions
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Toripalimab
Toripalimab Injection
Paclitaxel
Paclitaxel Injection
Carboplatin
Carboplatin Injection
Cisplatin
Cisplatin injection
5-fu
5-fu injection
Eligibility Criteria
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Inclusion Criteria
* Resectable or potentially resectable lesion;
* ECOG PS 0-1;
* Age \>18 years old;
* At least one target lesion according to RECIST 1.1;
* Proper function of the cardiovascular system, liver, kidney and bone marrow for receiving chemotherapy and surgery;
Exclusion Criteria
* Second malignancy within 5 years;
* Nasopharyngeal carcinoma;
* Active autoimmune diseases;
* HIV infected;
* Required prednisone dose \>=10mg daily;
* Heart attack within 6 months;
* Stroke within 6 months;
* Other conditions that investigators consider the patients are not suitable for PD-1antibody;
18 Years
ALL
No
Sponsors
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First Affiliated Hospital of Zhejiang University
OTHER
Responsible Party
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Yulong Zheng
Principal Investigator
Principal Investigators
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Nong Xu, MD
Role: STUDY_CHAIR
Zhejiang University
Locations
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Department of Medical Onocology, First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZJU20191451
Identifier Type: -
Identifier Source: org_study_id
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