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Neoadjuvant PD-1 Blockade in Resectable Oral Squamous Cell Carcinoma (NEOPBOSCC)

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ClinicalTrials.gov Identifier: NCT04649476
Recruitment Status : Not yet recruiting
First Posted : December 2, 2020
Last Update Posted : February 10, 2021
Sponsor:
Collaborator:
Jiangsu HengRui Medicine Co., Ltd.
Information provided by (Responsible Party):
Gang Chen, Hospital of Stomatology, Wuhan University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Oral Squamous Cell Carcinoma Drug: Camrelizumab Drug: Camrelizumanb plus TPF Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Neoadjuvant PD-1 Blockade Alone or Plus TPF Induction Chemotherapy for Resectable Local Advanced Oral Squamous Cell Carcinoma
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine


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.
Drug: Camrelizumab
The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery.
Other Name: SHR-1210

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.
Drug: Camrelizumanb plus TPF
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 Name: Docetaxel, Cisplatin, 5-Fluorouracil




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. Overall survival (OS) on each treatment arm. [ Time Frame: 24 months. ]
    OS is the time from randomization to death due to any cause.

  3. Adverse events (AEs). [ Time Frame: 24 months. ]
    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.


Other Outcome Measures:
  1. 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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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically documented oral squamous cell carcinoma (biopsy required).
  2. 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.
  3. Distant metastasis is excluded by chest CT and emission computed tomograph.
  4. 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.
  5. ECOG performance status 0-1.
  6. 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.
  7. Patient understands the study regimen, its requirements, risks and discomforts and is able and willing to sign the informed consent form.

Exclusion Criteria:

  1. History of ≥ 3 grade immune related adverse events (irAEs) or have not recovered to ≤ 1 grade irAEs from previous treatment.
  2. History of other treatments for cancer, including surgery, chemotherapy, radiotherapy or molecular targeted therapy within past 5 years.
  3. 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.
  4. Active autoimmune disease or history of refractory autoimmune disease.
  5. Active systemic infection requiring therapy.
  6. Patients who are receiving psychotropic drug or alcohol/drug abuse.
  7. Subjects with concurrent other active malignancies.
  8. HIV or untreated active HBV or HCV infections, or vaccinated (HBV, flu, varicella, etc) within 4 weeks before recruitment.
  9. Uncontrollable systemic diseases, including diabetes, hypertension, etc.
  10. History of stroke or transient ischemic attack within past 6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04649476


Contacts
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Contact: Gang Chen, M.D. +86 02787686215 geraldchan@whu.edu.cn

Locations
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China, Hubei
Hospital of Stomatology, Wuhan University
Wuhan, Hubei, China, 430079
Contact: Gang Chen, M.D.    +86 02787686215    geraldchan@whu.edu.cn   
Sponsors and Collaborators
Hospital of Stomatology, Wuhan University
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Gang Chen, MD Hospital of Stomatology, Wuhan University
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Responsible Party: Gang Chen, Chief physician, Professor, Hospital of Stomatology, Wuhan University
ClinicalTrials.gov Identifier: NCT04649476    
Other Study ID Numbers: HStomatologyWuhan
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Gang Chen, Hospital of Stomatology, Wuhan University:
Neoadjuvant
Oral squamous cell carcinoma
PD-1 blockade
Camrelizumab
TPF induction chemotherapy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Cisplatin
Docetaxel
Fluorouracil
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs