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Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable HNSCC

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Penpulimab injection
cisplatin
albumin-paclitaxel
Sponsored by
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients voluntarily joined the study, signed the informed consent, and had good compliance; Patients with 18 Years to 75 Years(at the time of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-1; Patients with untreated head and neck squamous cell carcinoma who were pathologically confirmed and determined to be suitable for surgical treatment were classified as stage III, IVa according to AJCC (8th Edition), including oral, oropharyngeal, hypopharyngeal, and laryngeal cancers Female patients of reproductive age should agree that birth control (such as intrauterine device, birth control pills, or condoms) must be used during the study period and for six months after completion; Having a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study. Exclusion Criteria: Patients who have previously used PD-1/PD-L1/CTLA-4 antibody therapy; Patients who require systemic treatment with corticosteroids (> 10mg daily prednisone equivalent) or other immunosuppressive drugs within 14 days prior to administration or during treatmentIn the absence of active autoimmune disease, inhaled or topical steroids and adrenocortical hormone at doses >10mg/ day equivalent to prednisone and adrenocortical hormone replacement at therapeutic doses not exceeding 10mg/ day prednisone are permitted; A history of any active immune or autoimmune disease, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Active or uncontrolled severe infection within 4 weeks prior to enrollment (CTCAE grade 2 infection); Abnormal function of major organs Patients with concomitant diseases that, in the investigator's judgment, may seriously endanger patients' safety or may interfere with the completion of the study, or are deemed unsuitable for inclusion for other reasons.

Sites / Locations

  • Shanghai Ninth People's Hostipal, Shanghai Jiao Tong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Penpulimab combined with cisplatin and albumin-paclitaxel neoadjuvant therapy

Arm Description

Penpulimab injection combined with cis-platinum and albumin-bound paclitaxel before surgery, 21 days as a treatment cycle. Adjuvant therapy was started within 6 weeks after surgery:Patients who achieved MPR after surgery were randomized 1:1 with standard adjuvant therapy(RT alone or combined with cisplatin) and Alternative adjuvant therapy(RT alone or combined with Penpulimab). Non-MPR patients receive standard adjuvant therapy

Outcomes

Primary Outcome Measures

Major pathological response(MPR)
Major pathologic response is based on the pathological examination on the post-operative specimens.

Secondary Outcome Measures

Disease-control Rate(DCR)
The proportion of subjects response of CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥4 weeks).
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Disease-free survival at 2 years(DFS at 2 years)
The proportion of subjects disease-free survival at 2 years
Overall Response Rate (ORR)
The proportion of subjects who achieves a best overall response of CR or PR.
Local recurrence-free survival at 2years(LRFS at 2 years)
The proportion of subjects local recurrence-free survival at 2years
distant metastasis-free survival at 2 years(DMFS at 2 years)
The proportion of subjects distant metastasis-free survival at 2years
OS at 2 years
The overall survival time refers to the time from initiating inductive therapy to death due to any cause.
pathologic complete response(pCR)
Pathological examination showed the presence of 0% active tumor in the tissue specimen

Full Information

First Posted
September 25, 2023
Last Updated
October 7, 2023
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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1. Study Identification

Unique Protocol Identification Number
NCT06081673
Brief Title
Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable HNSCC
Official Title
A Phase II Clinical Study of Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable Head and Neck Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2023 (Anticipated)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
October 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study aims to observe and explore the efficacy and safety of Penpulimab combined with chemotherapy for neoadjuvant and adjuvant therapy in patients with resectable head and neck squamous cell carcinoma.

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
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Penpulimab combined with cisplatin and albumin-paclitaxel neoadjuvant therapy
Arm Type
Experimental
Arm Description
Penpulimab injection combined with cis-platinum and albumin-bound paclitaxel before surgery, 21 days as a treatment cycle. Adjuvant therapy was started within 6 weeks after surgery:Patients who achieved MPR after surgery were randomized 1:1 with standard adjuvant therapy(RT alone or combined with cisplatin) and Alternative adjuvant therapy(RT alone or combined with Penpulimab). Non-MPR patients receive standard adjuvant therapy
Intervention Type
Drug
Intervention Name(s)
Penpulimab injection
Intervention Description
Penpulimab is a human immunoglobulin G1(IgG1) monoclonal antibody (mAb) directly programmed cell death-1 (PD-1). AK105 can effectively prevent human PD-1 binds to programmed cell death-1 ligand 1(PD-L1) and programmed cell death-1 ligand 2(PD-L2); 200mg,D1, IV(21 days/cycle).
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
Cisplatin :75mg/m2, D1, IV(21 days/cycle)
Intervention Type
Drug
Intervention Name(s)
albumin-paclitaxel
Intervention Description
albumin-paclitaxel :260mg/m2,IVgtt,D1(21 days/cycle)
Primary Outcome Measure Information:
Title
Major pathological response(MPR)
Description
Major pathologic response is based on the pathological examination on the post-operative specimens.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Disease-control Rate(DCR)
Description
The proportion of subjects response of CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥4 weeks).
Time Frame
Baseline up to 3 years.
Title
Adverse event rate
Description
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time Frame
Baseline up to 3 years.
Title
Disease-free survival at 2 years(DFS at 2 years)
Description
The proportion of subjects disease-free survival at 2 years
Time Frame
Baseline up to 2 years.
Title
Overall Response Rate (ORR)
Description
The proportion of subjects who achieves a best overall response of CR or PR.
Time Frame
Baseline up to 3 years.
Title
Local recurrence-free survival at 2years(LRFS at 2 years)
Description
The proportion of subjects local recurrence-free survival at 2years
Time Frame
Baseline up to 2 years.
Title
distant metastasis-free survival at 2 years(DMFS at 2 years)
Description
The proportion of subjects distant metastasis-free survival at 2years
Time Frame
Baseline up to 2 years.
Title
OS at 2 years
Description
The overall survival time refers to the time from initiating inductive therapy to death due to any cause.
Time Frame
Baseline up to 2 years.
Title
pathologic complete response(pCR)
Description
Pathological examination showed the presence of 0% active tumor in the tissue specimen
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients voluntarily joined the study, signed the informed consent, and had good compliance; Patients with 18 Years to 75 Years(at the time of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-1; Patients with untreated head and neck squamous cell carcinoma who were pathologically confirmed and determined to be suitable for surgical treatment were classified as stage III, IVa according to AJCC (8th Edition), including oral, oropharyngeal, hypopharyngeal, and laryngeal cancers Female patients of reproductive age should agree that birth control (such as intrauterine device, birth control pills, or condoms) must be used during the study period and for six months after completion; Having a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study. Exclusion Criteria: Patients who have previously used PD-1/PD-L1/CTLA-4 antibody therapy; Patients who require systemic treatment with corticosteroids (> 10mg daily prednisone equivalent) or other immunosuppressive drugs within 14 days prior to administration or during treatmentIn the absence of active autoimmune disease, inhaled or topical steroids and adrenocortical hormone at doses >10mg/ day equivalent to prednisone and adrenocortical hormone replacement at therapeutic doses not exceeding 10mg/ day prednisone are permitted; A history of any active immune or autoimmune disease, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Active or uncontrolled severe infection within 4 weeks prior to enrollment (CTCAE grade 2 infection); Abnormal function of major organs Patients with concomitant diseases that, in the investigator's judgment, may seriously endanger patients' safety or may interfere with the completion of the study, or are deemed unsuitable for inclusion for other reasons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Ruan, PhD
Phone
18019790370
Email
doctorruanmin@situ.edu.cn
Facility Information:
Facility Name
Shanghai Ninth People's Hostipal, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Ruan, PhD
Phone
18019790370
Email
doctorruanmin@situ.edu.cn
First Name & Middle Initial & Last Name & Degree
Min Ruan, PhD

12. IPD Sharing Statement

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Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable HNSCC

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