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AK112 Plus AP Regimen for Operable Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT06537011 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-08-06

No results posted yet for this study

Summary

This exploratory phase II study is designed to enroll patients with operable locally advanced head and neck squamous cell carcinoma, to observe the efficacy and safety of AK112 combined with chemotherapy as neoadjuvant therapy on them.

Conditions

  • Neoadjuvant Therapy of Operable Locally Advanced Head and Neck Squamous Cell Carcinoma

Interventions

DRUG

AK112

1. The patients are given AK112 combined with AP regimen every 3 weeks for 3 cycles before operation. 2. After the neoadjuvant therapy ,the patients will be assessed and be commanded surgery. 3.4-6 weeks after the surgery, the patients will be given chemoradiotherapy or radiotherapy alone decided on the conditon after surgery. 4.The participants will receive AK112 for 14 cycles after surgery.

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    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
2024-08-01
Primary Completion
2027-07-15
Completion
2028-07-30

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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 NCT06537011 on ClinicalTrials.gov