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Pembrolizumab in Combination With Low-dose PFas Neoadjuvant Treatment for Locally Advanced HNSCC

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

pembrolizumab+cisplatin + 5-FU

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years old, ≤ 85 years old
Histologically or cytologically proven squamous cell carcinoma of the head and neck(except T4b stage patients)
Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx. (Although they are admittedly of squamous cell types, the following tumors will be excluded because of the Y responsiveness to chemotherapy: tumors of the nasal and paranasal cavities, larynx and of the nasopharynx.)
At least one measurable lesion.
No previous chemotherapy, radiotherapy or surgery (other than biopsy) for SSCHN.
ECOG performance status of 0 or 1.
No active autoimmune disease
No concurrent malignancy
Life expectancy of greater than 12 weeks.
Adequate bone marrow, hepatic and renal functions.
Available for treatment and follow-up.

Exclusion Criteria:

Multiple organs failure.
distant metastases HNSCC.
HPV p16 positive oropharyngeal cancer
T4B advanced head and neck squamous cell carcinoma
Current severe, uncontrolled systemic disease.
Hepatitis B or active hepatitis C
Mental illness.
Peripheral neuropathy with CTCAE V5.0 ≥ level 2.
History of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic antibodies that required discontinuation of therapy.
Malignancies other than SCCHN within 5 years prior to enrollment.
Nasopharyngeal cancer.
Pregnant or lactating women.

Sites / Locations

Zhejiang Provincial People's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pembrolizumab+cisplatin + 5-fluorouracil

Arm Description

Use pembrolizumab+cisplatin + 5-fluorouracil

Outcomes

Primary Outcome Measures

Primary site CR rate after neoadjuvant therapy

Measure the primary site CR rate after neoadjuvant therapy

Secondary Outcome Measures

pfs

progression-free survival of all patients

dfs

disease free survival of all patients

Descending stage of tumor

Descending stage of primary lesion

One year local control rate

Incidence of adverse reactions

safety of neoadjuvant therapy

survival rates

Primary site pCR rate after neoadjuvant therapy

Full Information

NCT ID

NCT05446467

First Posted

June 30, 2022

Last Updated

December 26, 2022

Sponsor

Zhejiang Provincial People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05446467

Brief Title

Pembrolizumab in Combination With Low-dose PFas Neoadjuvant Treatment for Locally Advanced HNSCC

Official Title

Safety and Efficacy of Pembrolizumab in Combination With Low-dose PF (Cisplatin and 5-Fluorouracil) as Neoadjuvant Treatment for Locally Advanced Head and Neck Squamous Cell Carcinoma: a Multi-center, Single-arm Clinical Study Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 30, 2022 (Actual)

Primary Completion Date

May 1, 2024 (Anticipated)

Study Completion Date

August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

A phase Ⅱ open label multi-cencter clinical trail to evaluate the efficacy and safety of pembrolizumab combined with low-dose PF (cisplatin + 5-fluorouracil) in the neoadjuvant treatment of locally advanced head and neck squamous cell carcinoma

Detailed Description

The investigatorsdesigned a multi-center, single-arm, small sample clinical pilot study. In the clinical trial, patients were given regimes of induction therapy with PLPF (Pembrolizumab + Low dose- P (Platinum) F (5-Fluorouracil)): 6 cycles of Pembrolizumab treatment. Herein, the investigators describe eight consecutive unselected LA SCCHN (Locally Advanced Head and Neck Squamous Cell Carcinoma) patients based on 6 completed cycles of PLPF induction therapy.

6. Conditions and Keywords

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

Head and Neck Squamous Cell Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pembrolizumab+cisplatin + 5-fluorouracil

Arm Type

Experimental

Arm Description

Use pembrolizumab+cisplatin + 5-fluorouracil

Intervention Type

Drug

Intervention Name(s)

pembrolizumab+cisplatin + 5-FU

Intervention Description

ivgtt, pembrolizumab 200mg d1+cisplatin20 mg/m2 qd d1-d3 + 5-fluorouracil 3000mg/m last for 120hours , six circles

Primary Outcome Measure Information:

Title

Primary site CR rate after neoadjuvant therapy

Description

Measure the primary site CR rate after neoadjuvant therapy

Time Frame

Up to 6 months

Secondary Outcome Measure Information:

Title

pfs

Description

progression-free survival of all patients

Time Frame

up to 2 years

Title

dfs

Description

disease free survival of all patients

Time Frame

up to 2 years

Title

Descending stage of tumor

Description

Descending stage of primary lesion

Time Frame

up to 6 months

Title

One year local control rate

Description

One year local control rate

Time Frame

up to 6 months

Title

Incidence of adverse reactions

Description

safety of neoadjuvant therapy

Time Frame

up to 2 years

Title

Description

survival rates

Time Frame

2 years

Title

Primary site pCR rate after neoadjuvant therapy

Description

Primary site pCR rate after neoadjuvant therapy

Time Frame

Up to 6 months

Other Pre-specified Outcome Measures:

Title

Exploratory Outcome：biomarkers and single-cell sequencing

Description

Immune cell flow analysis, blood MRD detection analysis, single-cell sequencing analysis before and after immune neoadjuvant therapy.

Time Frame

up to 2 years

Title

Exploratory Outcome2

Description

Pembrolizumab in combination with low-dose PF (cisplatin + 5-fluorouracil) stratified by CPS PD-L1 status (CPS PD-L1<1, CPS PD-L1>1, and CPS PD-L1 not evaluable/uncertain) ) for the primary CR rate of stage 1 neoadjuvant therapy for locally advanced HNSCC

Time Frame

Up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years old, ≤ 85 years old Histologically or cytologically proven squamous cell carcinoma of the head and neck(except T4b stage patients) Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx. (Although they are admittedly of squamous cell types, the following tumors will be excluded because of the Y responsiveness to chemotherapy: tumors of the nasal and paranasal cavities, larynx and of the nasopharynx.) At least one measurable lesion. No previous chemotherapy, radiotherapy or surgery (other than biopsy) for SSCHN. ECOG performance status of 0 or 1. No active autoimmune disease No concurrent malignancy Life expectancy of greater than 12 weeks. Adequate bone marrow, hepatic and renal functions. Available for treatment and follow-up. Exclusion Criteria: Multiple organs failure. distant metastases HNSCC. HPV p16 positive oropharyngeal cancer T4B advanced head and neck squamous cell carcinoma Current severe, uncontrolled systemic disease. Hepatitis B or active hepatitis C Mental illness. Peripheral neuropathy with CTCAE V5.0 ≥ level 2. History of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic antibodies that required discontinuation of therapy. Malignancies other than SCCHN within 5 years prior to enrollment. Nasopharyngeal cancer. Pregnant or lactating women.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiao Ye, PhD

Phone

+86 18258107007

semper_fi@foxmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Minghua Ge, PhD

Organizational Affiliation

Zhejiang Provincial People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhejiang Provincial People's Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310014

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sisi Lin

Phone

18806532023

lsslzzlfll@126.com

12. IPD Sharing Statement

Learn more about this trial

Pembrolizumab in Combination With Low-dose PFas Neoadjuvant Treatment for Locally Advanced HNSCC

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