Induction Chemotherapy Combined With Camrelizumab in Locoregionally Advanced Hypopharyngeal Cancer

NCT04539600 | Unknown Phase 2

• 1 other identifier: hypopharyngeal SCC 002
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypopharyngeal Cancer; Immunotherapy; Induction Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival, PFS

  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.

  1 year

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  1 year

• Duration of Response（DoR）

  1 year

• Disease Control Rate (DCR)

  1 year

• Overall Survival (OS)

  1 year

• Adverse events (AE)

  1 year

Study Arms (1)

induction chemotherapy + anti-PD-1 antibody

EXPERIMENTAL

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.

Drug: Camrelizumab

Interventions

Camrelizumab DRUG

Camrelizumab is a type of anti-PD-1 antibody that could enhance the immune system of the patient to fight cancer.

induction chemotherapy + anti-PD-1 antibody

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Active tuberculosis, having antituberculosis therapy at present or within 1 year;
• Have active hepatitis B (HBV DNA ≥2000 IU/mL or 10\~4 copies/mL) and hepatitis C;
• Have other uncontrollable comorbidities;
• Knowing a history of psychotropic drug abuse, alcohol or drug abuse;
• Pregnant or breastfeeding, or expect to become pregnant during the clinical trial period.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Hypopharyngeal Neoplasms

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Shuang Wu, doctor

CONTACT

+862087755766; wush77@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 7, 2020
• Study Start: November 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: December 12, 2022
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

CN (1)