Pembrolizumab in Combination with Flutamide Treatment for Recurrence / Metastasis HNSCC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-85
SponsorZhejiang Provincial People's Hospital
About this trial
This study is a single center, single arm clinical trial for newly diagnosed patients with locally advanced head and neck squamous cell carcinoma. The main purpose is to evaluate the efficacy and safety of flutamide combined with standard immunotherapy for advanced / recurrent head and neck squamous cell carcinoma.
In our previous study, we found that AR can affect the occurrence and development of tumors by regulating the differentiation of cd8+t cells. We used three different castration drugs (flutamide, goserelin and abiraterone) in animal models to treat primary and tumor bearing head and neck squamous cell carcinoma mice respectively, and found that castration treatment could significantly inhibit the tumor growth of head and neck squamous cell carcinoma. In addition, in animal models, we compared the efficacy of the combination of castration therapy and low-dose cisplatin with that of the existing first-line chemotherapy drug cisplatin, and found that the combination of castration therapy and low-dose cisplatin can significantly improve the treatment effect of head and neck squamous cell carcinoma and reduce the adverse reactions brought by the drug. Therefore, we infer that flutamide combined with standard immunotherapy can fully inhibit the growth of HNSCC and improve the prognosis of HNSCC patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old, ≤ 85 years old
Histologically or cytologically proven squamous cell carcinoma of the head and neck; Patients diagnosed with head and neck squamous cell carcinoma with stage III and IV A without distant metastasis according to AJCC staging (8th editon), including squamous cell carcinoma of oropharyngeal (P16-), oral cavity, hypopharyngeal and larynx
Measurable primary lesions per RECIST 1.1 criteria
Treatment-naive patients without any previous disease-related therapy (except for diagnostic biopsies on primary lesions)
Disqualifiers
Patients who are suitable for local treatment and have the intention of local treatment
Received systemic treatment with Chinese patent drugs with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin) within 2 weeks before the first administration
Patients with tumor progression after previous treatment with flutamide analogues (antiandrogens)
Other malignant tumors occurred within 5 years or suffered from at the same time in the current period, except for cured non melanoma skin cancer or other tumors / cancers that have undergone radical treatment and have no signs of disease for at least 5 years;
Trial design
Design model
Single group
Treatments tested in this trial
Pembrolizumab+Flutamide
DrugPembrolizumab 200mg ivgtt once +Flutamide 250mg，Q8h
Treatment groups
54 Participants
are divided into 1 treatment groupGroup A: Pembrolizumab+FlutamideExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PFS
The Progression-Free-Survival of Interventions group
Time frame
Up to 4 yearsSecondary outcomes
1
ORR
The Objective Response Rate of Intervention group
Time frame
Up to 4 years2
DOR
The Disease Control Rate of intervention group
Time frame
Up to 4 years3
OS
The overall survival of paticipated patients
Time frame
Up to 4 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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