Induction Chemotherapy Combined With Camrelizumab in Locoregionally Advanced Hypopharyngeal Cancer

• ClinicalTrials.gov Identifier: NCT04539600
• Recruitment Status: Recruiting
• First Posted: September 7, 2020
• Last Update Posted: August 19, 2021
• Sponsor: Sun Yat-sen University
• Information provided by (Responsible Party): Zhen-Wei Peng, Sun Yat-sen University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypopharyngeal Cancer; Immunotherapy; Induction Chemotherapy	Drug: Camrelizumab	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Induction Chemotherapy Combined With Camrelizumab Followed by Chemoradiotherapy in Locoregionally Advanced Hypopharyngeal Cancer
• Actual Study Start Date: November 1, 2020
• Estimated Primary Completion Date: July 31, 2022
• Estimated Study Completion Date: December 12, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Camrelizumab; Camrelizumab is a type of anti-PD-1 antibody that could enhance the immune system of the patient to fight cancer.

Outcome Measures

Primary Outcome Measures :

1. Progression-free Survival, PFS [ Time Frame: 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 :

1. Objective Response Rate (ORR) [ Time Frame: 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.
2. Duration of Response（DoR） [ Time Frame: 1 year ]
   Response duration is measured from the time of initial response until documented tumor progression.
3. Disease Control Rate (DCR) [ Time Frame: 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).
4. Overall Survival (OS) [ Time Frame: 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.
5. Adverse events (AE) [ Time Frame: 1 year ]
   Adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Shuang Wu, doctor; +862087755766; wush77@mail.sysu.edu.cn

Locations

China, Guangdong

The First Affiliated Hospital of Sun Yat-sen University; Recruiting

Guangzhou, Guangdong, China, 510080

Contact: Shuang Wu +862087755766 wush77@mail.sysu.edu.cn

Sponsors and Collaborators

Sun Yat-sen University

More Information

• Responsible Party: Zhen-Wei Peng, Associate Professor, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT04539600
• Other Study ID Numbers: hypopharyngeal SCC 002
• First Posted: September 7, 2020
• Last Update Posted: August 19, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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