A Phase II, Single-center, Open-label, Single-arm Study of Induction Chemotherapy Combined With Immunotherapy for Locally Advanced Hypopharyngeal Carcinoma

Eye & ENT Hospital of Fudan University1 site in 1 country51 target enrollmentMay 21, 2020

ConditionsHypopharyngeal Carcinoma Immunotherapy Chemotherapy

InterventionsDocetaxel Cisplatin Capecitabine Camrelizumab

DrugsDocetaxel Cisplatin Capecitabine Camrelizumab

Overview

Phase: Phase 2
Intervention: Docetaxel
Conditions: Hypopharyngeal Carcinoma
Sponsor: Eye & ENT Hospital of Fudan University
Enrollment: 51
Locations: 1
Primary Endpoint: Overall Response Rate
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-center, multidisciplinary, open-label, single-arm prospective clinical study.

Detailed Description

In this study, 51 patients with hypohparyngeal carcinoma will be enrolled, These patients who have locally advanced-stage disease, including TNM stage cT3-4aN0-2M0 (AJCC 7th) and require a total laryngectomy as an initial therapy. Patients who achieved a CR or PR at the primary site after three cycles of TPF-regimen chemotherapy combined with immuotherapy will be referred for definitive RT and immuotherapy, while patients who received an evaluation of PD or SD at the primary site were referred for surgery followed by adjuvant RT/CRT.

Registry

clinicaltrials.gov

Start Date

May 21, 2020

End Date

January 16, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eye & ENT Hospital of Fudan University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients have histologically confirmed hypopharyngeal squamous cell carcinoma and require total laryngectomy, including the piriform fossa, postcricoid region, and posterior pharyngeal wall with TNM stage cT3-4aN0-2M0(AJCC 7th).
•Able to understand and willing to sign a written informed consent document.
•Age≥ 18 and≤ 70 years.
•Male or female.
•Performance status of ECOG 0-
•Expected lifetime \> 6 months.
•Normal blood test, hepatic and renal functions. Normal hearing. Blood test: WBC≥4.0×109/L，ANC≥2.0×109/L，PLT≥100×109/L，HGB≥100g/L；Hepatic function: ALT、AST\< upper limit of normal. Kidney function: Serum creatinine \< upper limit of normal value, and creatinine clearance rate ≥ 60 ml/min（Cockcroft-Gault formula）. Cardiac ultrasonography left ventricular ejection fraction \>50%.
•No prior allergic reaction to biological agents and/or ingredient in the drug.
•No drug abuse.
•Good compliance.

Exclusion Criteria

•Patients with cervical lymph node cN
•Have a history of other cancers in the past five years, radical or untreated prostate cancer (Gleason score ≤ 6), or complete treatment of breast ductal carcinoma in situ, except for patients with cured skin basal cell carcinoma or squamous cell skin cancer.
•Patients with target lesions who have received radiation therapy or surgery (except biopsy).
•Patients who have previously used chemotherapy, immunotherapy, or biological targeted therapy for primary tumors
•Patients who have participated in other clinical trials within 4 weeks before the test.
•Any of the following conditions in the first 6 months of random grouping: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, patients with transient ischemic attack or symptomatic pulmonary embolism.
•Patients with hypertension who cannot control well through single antihypertensive medication (systolic blood pressure \>140 mmHg, diastolic blood pressure \>90 mmHg);
•Patients with grade I or above coronary heart disease, arrhythmia (including men with a QTc interval \>450 ms, women \>470 ms), and cardiac insufficiency.
•Urinary protein was greater than ++ and 24-hour urinary protein quantification \>1.0 g.
•Many factors that affect oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction).

Arms & Interventions

Camrelizumab (PD-1 inhibitor) group

Induction chemotherapy combined with immunotherapy (TPF + Camrelizumab), q3w, 3 cycles in total: Docetaxel (domestic) 75 mg/m2 i.v. d1, Cisplatin 25 mg/m2 i.v. d1-3, Capecitabine 800 mg/m2 po bid d1-d14, Camrelizumab 200mg i.v. d1; Radical radiotherapy plus concurrent immunotherapy (CR or PR): Radiotherapy: Using intensity-modulated radiation therapy (IMRT). Primary site: GTV dose 66 (2.2Gy / fraction)-70 Gy (2Gy / fraction)；CTV 1.6-1.9 Gy / fraction. Cervical lymph nodes: Radiotherapy plan is the same as the radiotherapy plan of original site; Concurrent immunotherapy : Camrelizumab 200mg i.v. d1, d22; Maintenance period: After completing concurrent chemoradiotherapy combined with immunotherapy, Camrelizumab 200 mg q3w will be given up to 12 months (calculated from the time of the first dose of PD-1 immunotherapy).

Intervention: Docetaxel