Induction Chemotherapy Combined With Camrelizumab in Locoregionally Advanced Hypopharyngeal Cancer

Phase 2

• Conditions: Induction Chemotherapy; Hypopharyngeal Cancer; Immunotherapy
• Interventions: Drug: Camrelizumab

• Registration Number: NCT04539600
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-07
• Study Start: 2020-11-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-14
• Last Update Posted: 2021-08-19
• Primary Completion: 2022-07-31
• Study Completion: 2022-12-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
induction chemotherapy + anti-PD-1 antibody	Camrelizumab	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.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival, PFS	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.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	1 year	Defined as the portion of patients with a tumor size reduction of a predefined amount for a minimum time period. Tumor response will be measured according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1.
Duration of Response（DoR）	1 year	Response duration is measured from the time of initial response until documented tumor progression.
Disease Control Rate (DCR)	1 year	Refers to the proportion of patients whose tumors have shrunk or been stable for a certain period of time, including cases of complete response (CR), partial response (PR), or stable disease (SD).
Overall Survival (OS)	1 year	Defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.
Adverse events (AE)	1 year	Adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China