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
Official title: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Temporal Bone Squamous Cell Carcinoma
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The resectability rate of pablizumab in combination with cisplatin and 5-FU for unresectable temporal bone squamous carcinoma as neoadjuvant therapy
timeFrame: up to three months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Suijun CHEN, doctor
role: STUDY_DIRECTOR
References: