Induction Chemotherapy Combined With Camrelizumab Followed by Chemoradiotherapy in Locoregionally Advanced Hypopharyngeal Cancer

Sun Yat-sen University1 site in 1 country23 target enrollmentNovember 1, 2020

ConditionsHypopharyngeal Cancer Immunotherapy Induction Chemotherapy

InterventionsCamrelizumab

DrugsCamrelizumab

Overview

Phase: Phase 2
Intervention: Camrelizumab
Conditions: Hypopharyngeal Cancer
Sponsor: Sun Yat-sen University
Enrollment: 23
Locations: 1
Primary Endpoint: Progression-free Survival, PFS
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is a single center phase II trial. The purpose is to investigate both the efficacy and safety of chemotherapy combined with anti-PD-1 antibody Followed by chemoradiotherapy in locoregionally advanced hypopharyngeal cancer.

Registry

clinicaltrials.gov

Start Date

November 1, 2020

End Date

December 12, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Zhen-Wei Peng

Associate Professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Age: 18-75 years;
•Hypopharyngeal squamous cell carcinoma confirmed by histopathology;
•No distant metastases, stage III-IV (According to the 8th UICC/AJCC TNM staging system );
•At least 1 measurable lesion (according to RECIST1.1), and the lesion has not been treated;
•Provide tissues for biomarker analysis;
•ECOG PS 0-1;
•Adequate hematologic, hepatic and renal function: ANC ≥ 1.5x10\^9/L, Hb ≥ 90g/L, PLT ≥ 100 x10\^9/L, albumin ≥ 28g/L, total bilirubin \< 1.5×ULN at diagnosis or after biliary drainage, ALT and AST \< 5×ULN, BUN、CREA\<1.5×ULN, creatinine clearance rate ≥ 45ml/min;
•Contraception during the study;
•At least 12 weeks of life expectancy;
•Willing to join the study and sign informed consent.

Exclusion Criteria

•Allergic to any component of carrelizumab, cisplatin and other platinum drugs;
•Have received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or CTLA-4 antibody therapy in the past;
•Received biological treatment or participated in clinical trial of other drugs or devices within 4 weeks before enrollment;
•Have other malignant tumors within 5 years, except for fully treated basal cell/squamous cell skin cancer/cervical cancer;
•Have corticosteroids (\>10 mg prednisone equivalent dose per day) or other immunosuppressive agents for systemic treatment within 2 weeks before the first use of the study drug, except for local inflammation and prevention of allergies, nausea or vomiting;
•Uncontrolled clinical symptoms or diseases of the heart, such as: heart failure above NYHA II, unstable angina, myocardial infarction within 1 year；
•Have severe infections (CTCAE\> Grade 2) occurred within 4 weeks before the first use of the study drug;
•Have active autoimmune diseases, autoimmune diseases, but not including autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; type 1 diabetes with stable doses of insulin; vitiligo or cured childhood asthma/allergies;
•A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation;
•A history of interstitial lung disease (excluding radiation pneumonia that has not been treated with hormones) and a history of non-infectious pneumonia;

Arms & Interventions

induction chemotherapy + anti-PD-1 antibody

Camrelizumab (200 mg, Q3w, 2 cycles in total) combined with induction chemotherapy (taxane-containing regimen, Q3w, 2 cycles in total) followed by concurrent radiotherapy and chemotherapy.

Intervention: Camrelizumab

Outcomes

Primary Outcomes

Progression-free Survival, PFS

Time Frame: 1 year

Defined as the time from randomization until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.