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

NCT06081673 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-10-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Penpulimab injection

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).

DRUG

cisplatin

Cisplatin :75mg/m2, D1, IV(21 days/cycle)

DRUG

albumin-paclitaxel

albumin-paclitaxel :260mg/m2,IVgtt,D1(21 days/cycle)

Sponsors & Collaborators

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2024-12-30
Completion
2026-10-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06081673 on ClinicalTrials.gov