MedTrace Logo

Cetuximab+Zimberelimab in Combination With Cisplatin and Nab-paclitaxel in Resctable Head and Neck Squamous Cell Carcinoma

NCT06107114 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-11-22

No results posted yet for this study

Summary

This study is a single arm phase ll trial including 52 patients with T2N2-3M0#T3-4N0-3M0 (III-V) head and neck squamous cell carcinoma(HNSCC) eligible forresection, who receive Cetuximab+ Zimberelimab combined with cisplatin and Nab.paclitaxel.This proposed study will evaluate the efficacy and safety of preoperative administration of Cetuximab+ Zimberelimab combined with chemotherapy in Head and Neck Squamous Cell Carcinoma(HNSCC) who are about to undergo surgery.

Conditions

  • Hend and Neck Squamous Cell Carcinoma Locally Advanced Operable

Interventions

DRUG

Cetuximab

Cetuximab 400mg/m2 (The first week), 250mg/m2(Follow-up weekly) The drug was administered every week (QW). The treatment regimen is recommended for three cycles until the researchers determine that the subjects cannot continue to benefit, until the disease progression (PD), the toxicity cannot be tolerated, the treatment is delayed by more than 14 days, or the patient withdraws the informed consent form or dies.

DRUG

Zimberelimab

Zimberelimab 240 mg, The drug was administered every week (Q3W), and 21 days (Q3W) was a treatment cycle. The treatment regimen is recommended for three cycles until the researchers determine that the subjects cannot continue to benefit, until the disease progression (PD), the toxicity cannot be tolerated, the treatment is delayed by more than 14 days, or the patient withdraws the informed consent form or dies.

DRUG

Docetaxel

Docetaxel 75mg/m2. Intravenous infusion was given every 3 weeks (Q3W), and 21 days (Q3W) was a treatment cycle. Treatment regimen is recommended for 3 cycles.

DRUG

Cisplatin

Cisplatin 60mg/m2. Intravenous infusion was given every 3 weeks (Q3W), and 21 days (Q3W) was a treatment cycle. Treatment regimen is recommended for 3 cycles.

Sponsors & Collaborators

  • Xuekui Liu

    lead OTHER

Principal Investigators

  • Xuekui Liu · Sun Yat Sun University Cancer Center, 651 Dongfeng East Road

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-11-01
Completion
2024-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06107114 on ClinicalTrials.gov