Induction Chemotherapy Combined With Camrelizumab in Locoregionally Advanced Hypopharyngeal Cancer

NCT ID: NCT04539600

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2022-12-12

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: DRUG

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

Interventions

Camrelizumab

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhen-Wei Peng

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shuang Wu, doctor

Role: CONTACT

wush77@mail.sysu.edu.cn

+862087755766

Facility Contacts

Shuang Wu

Role: primary

wush77@mail.sysu.edu.cn

+862087755766

Other Identifiers

hypopharyngeal SCC 002

Identifier Type: -

Identifier Source: org_study_id