Induction Chemotherapy Combined With Camrelizumab in Locoregionally Advanced Hypopharyngeal Cancer

Brief Title

Induction Chemotherapy Combined With Camrelizumab in Locoregionally Advanced Hypopharyngeal Cancer

Official Title

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

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Progression-free Survival, PFS

Secondary Outcome

 Objective Response Rate (ORR)

Condition

Hypopharyngeal Cancer

Intervention

Camrelizumab

Study Arms / Comparison Groups

 induction chemotherapy + anti-PD-1 antibody
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

23

Start Date

September 1, 2020

Completion Date

December 12, 2022

Primary Completion Date

July 31, 2022

Eligibility Criteria

        Inclusion Criteria:

          1. Age: 18-75 years;

          2. Hypopharyngeal squamous cell carcinoma confirmed by histopathology;

          3. No distant metastases, stage III-IV (According to the 8th UICC/AJCC TNM staging system
             );

          4. At least 1 measurable lesion (according to RECIST1.1), and the lesion has not been
             treated;

          5. Provide tissues for biomarker analysis;

          6. ECOG PS 0-1;

          7. 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;

          8. Contraception during the study;

          9. At least 12 weeks of life expectancy;

         10. Willing to join the study and sign informed consent.

        Exclusion Criteria:

          1. Allergic to any component of carrelizumab, cisplatin and other platinum drugs;

          2. Have received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or CTLA-4 antibody therapy
             in the past;

          3. Received biological treatment or participated in clinical trial of other drugs or
             devices within 4 weeks before enrollment;

          4. Have other malignant tumors within 5 years, except for fully treated basal
             cell/squamous cell skin cancer/cervical cancer;

          5. 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;

          6. Uncontrolled clinical symptoms or diseases of the heart, such as: heart failure above
             NYHA II, unstable angina, myocardial infarction within 1 year;

          7. Have severe infections (CTCAE> Grade 2) occurred within 4 weeks before the first use
             of the study drug;

          8. 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;

          9. 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;

         10. A history of interstitial lung disease (excluding radiation pneumonia that has not
             been treated with hormones) and a history of non-infectious pneumonia;

         11. Active tuberculosis, having antituberculosis therapy at present or within 1 year;

         12. Have active hepatitis B (HBV DNA ≥2000 IU/mL or 10~4 copies/mL) and hepatitis C;

         13. Have other uncontrollable comorbidities;

         14. Knowing a history of psychotropic drug abuse, alcohol or drug abuse;

         15. Pregnant or breastfeeding, or expect to become pregnant during the clinical trial
             period.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT04539600

Organization ID

hypopharyngeal SCC 002


Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University


Study Sponsor

, , 


Verification Date

September 2020