- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04649476
Neoadjuvant PD-1 Blockade in Resectable Oral Squamous Cell Carcinoma (NEOPBOSCC)
August 17, 2022 updated by: Gang Chen, Hospital of Stomatology, Wuhan University
A Randomized Phase II Study of Neoadjuvant PD-1 Blockade Alone or Plus TPF Induction Chemotherapy for Resectable Local Advanced Oral Squamous Cell Carcinoma
The purpose of this study is to investigate the safety and feasibility of neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy in subjects with resectable local advanced oral squamous cell carcinoma.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to investigate the safety and feasibility of neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy in subjects with resectable local advanced OSCC.
And on this basis, we will explore the changes of the profiles and functions of immune cells within tumors, lymph nodes and peripheral blood after the experimental interventions, as well as their correlation with the patients' response and prognosis.
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Hubei
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Wuhan, Hubei, China, 430079
- Hospital of Stomatology, Wuhan University
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically documented oral squamous cell carcinoma (biopsy required).
- Local advanced oral squamous cell carcinoma (clinical stage T1-2N1-3M0, T3-4aN0-3M0) with resection option for potential cure, as assessed by a faculty surgeon at Hospital of Stomatology, Wuhan University.
- Distant metastasis is excluded by chest CT and emission computed tomograph.
- Adequate organ function as follows: 1) Leukocyte count ≥ 2,000/mm3; 2) Absolute neutrophil count ≥ 1,000/mm3; 3) Platelet count ≥ 100,000/mm3; 4) Hemoglobin ≥ 90 g/L; 5) Serum albumin ≥30 g/L; 6) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); 7) AST (SGOT) and ALT (SGPT) < 2.5 × ULN; 8) ALP ≤ 2.5 × ULN; 9) Prothrombin time-international normalized ratio ≤ 1.5; 10) Serum creatinine ≤ 1.5 × ULN; 11) INR/PT≤ 1.5; 12) TSH ≤ ULN.
- ECOG performance status 0-1.
- Female patient tested HCG negative in serum or urine within 7 days prior to the start of investigational product. Both patient and partner must agree to use contraception prior to study entry and for the duration of study participation and for up to 120 days after the last dose of PD-1 blockade.
- Patient understands the study regimen, its requirements, risks and discomforts and is able and willing to sign the informed consent form.
Exclusion Criteria:
- History of ≥ 3 grade immune related adverse events (irAEs) or have not recovered to ≤ 1 grade irAEs from previous treatment.
- History of other treatments for cancer, including surgery, chemotherapy, radiotherapy or molecular targeted therapy within past 5 years.
- Previous therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 or any other antibody targeting T cell co-regulatory pathways.
- Active autoimmune disease or history of refractory autoimmune disease.
- Active systemic infection requiring therapy.
- Patients who are receiving psychotropic drug or alcohol/drug abuse.
- Subjects with concurrent other active malignancies.
- HIV or untreated active HBV or HCV infections, or vaccinated (HBV, flu, varicella, etc) within 4 weeks before recruitment.
- Uncontrollable systemic diseases, including diabetes, hypertension, etc.
- History of stroke or transient ischemic attack within past 6 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neoadjuvant PD-1 blockade alone
The participants will receive 3 doses of neoadjuvant PD-1 blockade.
Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
|
The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery.
Other Names:
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Experimental: Neoadjuvant PD-1 blockade plus TPF induction chemotherapy
The participants will receive 3 doses of PD-1 blockade and 2 courses of TPF induction chemotherapy.
Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
|
The participants will receive camrelizumab (200 mg) through intravenous infusion each 2-week cycle, and docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2, 5-Fluorouracil (F) 750 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathologic response.
Time Frame: 8 weeks.
|
Pathologic response of resected tumors and lymph nodes to neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy.
The rate of major pathologic response, defined as <10% residual viable tumor cells in the resected specimen.
|
8 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiographic response.
Time Frame: 8 weeks.
|
Clinical response of tumors and lymph nodes to neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy, as evaluated by radiographic examinations and defined by RECIST 1.1.
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8 weeks.
|
Event-free survival (EFS) rate on each treatment arm.
Time Frame: 24 months.
|
EFS is the time from the date of randomization to the date of first record of disease progression as defined by RECIST 1.1.
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24 months.
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Overall survival (OS) on each treatment arm.
Time Frame: 24 months.
|
OS is the time from randomization to death due to any cause.
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24 months.
|
Adverse events (AEs).
Time Frame: 24 months.
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Number of participants experiencing any sign, symptom, disease, or worsening of preexisting conditions temporally associated with the experimental interventions or irrespective of the experimental interventions.
|
24 months.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the level of circualting exosomal PD-L1.
Time Frame: 24 months.
|
The level of circulating exosomal PD-L1 at serial time points pre- and on-treatment, as detected by enzyme-linked immunosorbent assay (ELISA).
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24 months.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Gang Chen, MD, Hospital of Stomatology, Wuhan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 22, 2021
Primary Completion (Actual)
August 10, 2022
Study Completion (Anticipated)
August 10, 2024
Study Registration Dates
First Submitted
November 18, 2020
First Submitted That Met QC Criteria
November 24, 2020
First Posted (Actual)
December 2, 2020
Study Record Updates
Last Update Posted (Actual)
August 19, 2022
Last Update Submitted That Met QC Criteria
August 17, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Head and Neck Neoplasms
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
- Cisplatin
- Fluorouracil
Other Study ID Numbers
- HStomatologyWuhan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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