Clinical trial NCT04539600: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hypopharyngeal Cancer
Immunotherapy
Induction Chemotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression-free Survival, PFS
timeFrame: 1 year
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 1 year
measure: Duration of Response（DoR）
timeFrame: 1 year
measure: Disease Control Rate (DCR)
timeFrame: 1 year
measure: Overall Survival (OS)
timeFrame: 1 year
measure: Adverse events (AE)
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References: