- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05444673
A Prospective, Single-arm Clinical Study of Pabrolizumab in Combination With Cisplatin + 5-FU for the Neoadjuvant Treatment of Unresectable, Advanced Squamous Carcinoma of the Temporal Bone Single-arm Clinical Study
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Suijun CHEN, doctor
- Phone Number: 13609757219
- Email: Chensuijun1974@163.com
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510030
- Recruiting
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
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Contact:
- Suijun CHEN, doctor
- Phone Number: 13609757219
- Email: Chensuijun1974@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with advanced temporal bone carcinoma evaluated by an otolaryngologist as non-R0 resectable; CPS score > 20.
- Patients who had undergone surgery, chemotherapy, radiotherapy, etc.
- Patients with T4 advanced temporal bone cancer, Patients with nasopharyngeal carcinoma after radiotherapy
Hematology, biochemistry, and organ function:
- Hemoglobin ≥100 g/L (can be maintained or exceeded by transfusion);
- Neutrophil absolute count ≥2.0×109/L;
- Platelet count ≥100×109/L;
- Total bilirubin ≤1.5 times the upper limit of normal;
- Alt and ASPARTate aminotransferase ≤2.5 times the upper limit of normal value;
- Creatinine ≤1.25 times the upper limit of normal; The creatinine clearance rate was ≥60mL/min.
- Women of childbearing age (18-49 years) must exclude pregnancy.
General admission criteria:
- Obtain informed consent signed by the patient or his legal representative;
- Good patient compliance;
- Medications can be taken orally;
- Male or female aged ≥18 years and < 75 years;
- ECOG behavior status score 0-1, life expectancy > 12 weeks;
- Both men and women of reproductive age agreed to use a reliable method of contraception before entering the trial, during the study, and up to 8 weeks after stopping the drug.
Exclusion Criteria:
Patients who had cancer other than temporal bone cancer during the five years before the initiation of treatment in this study were excluded from: fully cured with surgery and disease-free survival of at least 5 years; carcinoma in situ of the cervix; cured basal cell carcinoma; bladder epithelial neoplasms (including Ta and Tis);
- Known allergy to carboplatin, 5-FU, or any of the ingredients in this product;
- Confirmed or suspected active immune disease. The following conditions can be included: the absence of a specific external stimulus will not develop; Systemic treatment is not required.
- systemic use of steroid hormones (> 10mg/ day equivalent of prednisone) or immunosuppressants within 14 days before first administration. Aerosolized inhalation or topical administration of steroid steroids may be used in the absence of active immune disease.
- Previous interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy, or any clinically proven active interstitial lung disease;
- Any unstable systemic disease, including: Active infection, uncontrolled hypertension, unstable angina, the onset of angina within the last 3 months, congestive heart failure (≥ New York Heart Association [NYHA] Class II), myocardial infarction (6 months before enrollment), severe arrhythmia requiring medication, liver, kidney, or metabolic disease;
- Known human immunodeficiency virus (HIV) infection, active hepatitis B or C;
- Patients with mixed small cell lung cancer components;
- Pregnant or lactating women;
- A clear history of neurological or psychiatric disorders, including epilepsy or dementia;
- Conditions deemed unsuitable for inclusion by other researchers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Paprizumab combined with cisplatin and 5-FU
Patients received four cycles of paprizumab (200mg iv, 21-day cycle) in combination with 5-fu (500mg/m2 iv) plus cisplatin (80mg/m2 iv, 21-day cycle).
Reassessment after completion of neoadjuvant chemotherapy was performed in operable patients.
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Patients with advanced temporal bone cancer were treated with pabulizumab combined with cisplatin and 5-FU
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The resectability rate of pablizumab in combination with cisplatin and 5-FU for unresectable temporal bone squamous carcinoma as neoadjuvant therapy
Time Frame: up to three months
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Resectability rate of tumors
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up to three months
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Collaborators and Investigators
Investigators
- Study Director: Suijun CHEN, doctor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-KY-068
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbCompletedStage IVA Oral Cavity Squamous Cell Carcinoma | Stage IV Hypopharyngeal Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage IVA Oropharyngeal Squamous Cell Carcinoma | Stage IVB Laryngeal Squamous Cell Carcinoma | Stage IVB Oropharyngeal Squamous Cell Carcinoma | Stage... and other conditionsUnited States
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UNC Lineberger Comprehensive Cancer CenterMayo Clinic; National Institute of Dental and Craniofacial Research (NIDCR)RecruitingCarcinoma, Squamous Cell | Head and Neck Squamous Cell Carcinoma | Oropharyngeal Squamous Cell Carcinoma | Oropharynx Squamous Cell CarcinomaUnited States
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Yonsei UniversityCompleted
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SanofiCompleted
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