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Neoadjuvant Cadonilimab in Combination With Cisplatin and Nab-paclitaxel in Resectable Head and Neck Squamous Cell Carcinoma

NCT06023875 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-09-05

No results posted yet for this study

Summary

This study is a single arm phase ll trial including 30 patients with T2N2-3M0、T3-4N0-3M0 (lll-V) head and neck squamous cell carcinoma (HNSCC) eligible forresection, who receive neo-adjvuant Cadonilimab combined with cisplatin and Nab.paclitaxel.This proposed study will evaluate the efficacy and safety of preoperativeadministration of Cadonilimab combined with chemotherapy in Head and Neck Squamous Cell Carcinoma (HNSCC) who are about to undergo surgery.

Conditions

Interventions

DRUG

Cadonilimab

Cadonilimab 10mg/kg. The drug was administered every 3 weeks (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

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
2023-07-19
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

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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 NCT06023875 on ClinicalTrials.gov