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

Primary Purpose

Oral Squamous Cell Carcinoma

Status

Active

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Camrelizumab

Camrelizumanb plus TPF

About this trial

This is an interventional treatment trial for Oral Squamous Cell Carcinoma focused on measuring Neoadjuvant, Oral squamous cell carcinoma, PD-1 blockade, Camrelizumab, TPF induction chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital of Stomatology, Wuhan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Neoadjuvant PD-1 blockade alone

Neoadjuvant PD-1 blockade plus TPF induction chemotherapy

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Pathologic response.

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.

Secondary Outcome Measures

Radiographic response.

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.

Event-free survival (EFS) rate on each treatment arm.

EFS is the time from the date of randomization to the date of first record of disease progression as defined by RECIST 1.1.

Overall survival (OS) on each treatment arm.

OS is the time from randomization to death due to any cause.

Adverse events (AEs).

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.

Full Information

NCT ID

NCT04649476

First Posted

November 18, 2020

Last Updated

August 17, 2022

Sponsor

Hospital of Stomatology, Wuhan University

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04649476

Brief Title

Neoadjuvant PD-1 Blockade in Resectable Oral Squamous Cell Carcinoma

Acronym

NEOPBOSCC

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 22, 2021 (Actual)

Primary Completion Date

August 10, 2022 (Actual)

Study Completion Date

August 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital of Stomatology, Wuhan University

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Squamous Cell Carcinoma

Keywords

Neoadjuvant, Oral squamous cell carcinoma, PD-1 blockade, Camrelizumab, TPF induction chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Neoadjuvant PD-1 blockade alone

Arm Type

Experimental

Arm Description

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.

Arm Title

Neoadjuvant PD-1 blockade plus TPF induction chemotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Camrelizumab

Other Intervention Name(s)

SHR-1210

Intervention Description

The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery.

Intervention Type

Drug

Intervention Name(s)

Camrelizumanb plus TPF

Other Intervention Name(s)

Docetaxel, Cisplatin, 5-Fluorouracil

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pathologic response.

Description

Time Frame

8 weeks.

Secondary Outcome Measure Information:

Title

Radiographic response.

Description

Time Frame

8 weeks.

Title

Event-free survival (EFS) rate on each treatment arm.

Description

EFS is the time from the date of randomization to the date of first record of disease progression as defined by RECIST 1.1.

Time Frame

24 months.

Title

Overall survival (OS) on each treatment arm.

Description

OS is the time from randomization to death due to any cause.

Time Frame

24 months.

Title

Adverse events (AEs).

Description

Time Frame

24 months.

Other Pre-specified Outcome Measures:

Title

Changes in the level of circualting exosomal PD-L1.

Description

The level of circulating exosomal PD-L1 at serial time points pre- and on-treatment, as detected by enzyme-linked immunosorbent assay (ELISA).

Time Frame

24 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gang Chen, MD

Organizational Affiliation

Hospital of Stomatology, Wuhan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital of Stomatology, Wuhan University

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430079

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Neoadjuvant PD-1 Blockade in Resectable Oral Squamous Cell Carcinoma

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