Induction Chemotherapy Combined With Immunotherapy for Locally Advanced Hypopharyngeal Carcinoma

NCT04156698 | Unknown Phase 2

• 1 other identifier: zhouliang
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypopharyngeal Carcinoma; Immunotherapy; Chemotherapy

Keywords

Locally advanced hypopharyngeal squamous cell carcinoma; Programmed death protein - 1 inhibitor; Camrelizumab; Objective response rate; Safety profiles

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  The proportion of patients with partial and complete response as defined by RECIST 1.1 after induction therapy

  9 weeks

Secondary Outcomes (4)

• LPR

  3 years

• PFS

  3 years

• MFS

  3 years

• OS

  3 years

Study Arms (1)

Camrelizumab (PD-1 inhibitor) group

EXPERIMENTAL

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).

Drug: Docetaxel; Drug: Cisplatin; Drug: Capecitabine; Drug: Camrelizumab

Interventions

Docetaxel DRUG

Docetaxel is a chemotherapy drug.

Also known as: Docetaxel (domestic)

Camrelizumab (PD-1 inhibitor) group

Cisplatin DRUG

Cisplatin is a chemotherapy drug.

Also known as: chemotherapy drug

Camrelizumab (PD-1 inhibitor) group

Capecitabine DRUG

Capecitabine is a chemotherapy drug.

Also known as: chemotherapy drug

Camrelizumab (PD-1 inhibitor) group

Camrelizumab DRUG

Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.

Also known as: Anti-PD-1 Antibody (Jiangsu Hengrui)

Camrelizumab (PD-1 inhibitor) group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 0-2.
• 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.
• No other important related diseases (such as other tumors, severe heart, lung and central nervous system diseases, etc.).
• Negative pregnancy test (for female patients with fertility).
• Male patients with fertility and female patients with fertility and pregnancy risk must agree to use contraceptive methods throughout the study period, and continued until at least 6 months after the last dose of cisplatin and 30 days after the last dose of PD-1 antibody/placebo (whichever occurs later). Female patients who do not have fertility (ie meet at least one of the following criteria): Have undergone hysterectomy and/or bilateral oophorectomy with archival records, medically confirmed ovarian function decline; In postmenopausal state. It is defined as: At least 12 months of continuous menstruation without other pathological or physiological reasons, and the status confirmed by serum follicle stimulating hormone (FSH) levels is consistent with postmenopausal status.

You may not qualify if:

• Patients with cervical lymph node cN3.
• 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).
• Patients with abnormal coagulation function（INR\>1.5、APTT\>1.5 ULN）and bleeding tendency.
• Patients with a history of psychotropic substance abuse that is active or has a mental disorder.
• Patients who required systemic treatment with corticosteroids (\>10 mg prednisone equivalent daily) or other immunosuppressive agents within 2 weeks prior to the first use of the study drug.
• Patients with a history of severe allergies or allergies; patients with active autoimmune diseases that may worsen when receiving immunostimulants; patients with type 1 diabetes, vitiligo, psoriasis, or hypothyroidism or hyperthyroidism who do not require immunosuppressive therapy are eligible to participate in the study.
• Patients who have previously been diagnosed with immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related diseases. Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (HBV) surface antigen is positive at screening, or patients with positive HCV RNA \[ribonucleic acid\] when positive for anti-HCV antibody screening test.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Eye & ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Conditions

Hypopharyngeal Neoplasms

Interventions

Docetaxel; Home Environment; Cisplatin; Capecitabine; camrelizumab

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Residence Characteristics; Demography; Population Characteristics; Family Characteristics; Socioeconomic Factors; Environment; Environment and Public Health; Epidemiologic Measurements; Public Health; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Liang Zhou, PhD.

  Eye & ENT Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 7, 2019
• Study Start: May 21, 2020
• Primary Completion: April 16, 2023
• Study Completion: January 16, 2026
• Last Updated: August 9, 2023

Record last verified: 2023-08

Locations

CN (1)