Induction Chemotherapy Combined With Camrelizumab in Locoregionally Advanced Hypopharyngeal Cancer
Induction Chemotherapy Combined With Camrelizumab Followed by Chemoradiotherapy in Locoregionally Advanced Hypopharyngeal Cancer
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510080
- Recruiting
- The First Affiliated Hospital of Sun Yat-Sen University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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.
|
Camrelizumab is a type of anti-PD-1 antibody that could enhance the immune system of the patient to fight cancer.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 year
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 year
|
|
Duration of Response(DoR)
Time Frame: 1 year
|
Response duration is measured from the time of initial response until documented tumor progression.
|
1 year
|
|
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).
|
1 year
|
|
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.
|
1 year
|
|
Adverse events (AE)
Time Frame: 1 year
|
Adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0).
|
1 year
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ANTICIPATED)
Primary Completion
Study Completion (ANTICIPATED)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- hypopharyngeal SCC 002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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