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

Temporal bone cancer accounts for 0.2% of head and neck cancers. Advanced temporal bone cancer often involves structures such as apices, internal carotid artery canals, and dura mater, and negative margins cannot be obtained during surgery. The recurrence rate after surgery is as high as 70%, and the 2-year survival rate is only 11%. Crestor, or paprolizumab, is a monoclonal antibody to PD1 that blocks the interaction between PD1 and the dura mater. The NCCN guidelines recommend that paprolizumab be used in combination with platinum-based anti-tumor agents. The NCCN guidelines recommend pablizumab in combination with platinum and 5-FU for the first-line treatment of recurrent, unresectable head and neck squamous carcinoma, but this regimen is not recommended for the treatment of recurrent, unresectable head and neck squamous carcinoma. This study is intended to investigate the use of pablizumab in combination with platinum and 5-FU for the first-line treatment of recurrent unresectable squamous head and neck cancer. This study investigates the effectiveness of pablizumab in combination with cisplatin and 5-FU for the adjuvant treatment of recurrent, unresectable temporal bone cancer. temporal bone cancer.

Study Overview

• Status: Recruiting
• Conditions: Temporal Bone Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Paprizumab combined with cisplatin and 5-FU

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Suijun CHEN, doctor; Phone Number: 13609757219; Email: Chensuijun1974@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510030
      • Recruiting
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Contact: Suijun CHEN, doctor; Phone Number: 13609757219; Email: Chensuijun1974@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with advanced temporal bone carcinoma evaluated by an otolaryngologist as non-R0 resectable; CPS score > 20.
2. Patients who had undergone surgery, chemotherapy, radiotherapy, etc.
3. Patients with T4 advanced temporal bone cancer, Patients with nasopharyngeal carcinoma after radiotherapy

4. 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.

5. 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)

Number of Arms

1

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.	Drug: Paprizumab combined with cisplatin and 5-FU; Patients with advanced temporal bone cancer were treated with pabulizumab combined with cisplatin and 5-FU

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	Resectability rate of tumors	up to three months

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• 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): June 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: June 26, 2022
• First Submitted That Met QC Criteria: July 5, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Antineoplastic Agents; Cisplatin
• Other Study ID Numbers: 2022-KY-068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No