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Neoadjuvant Adebrelimab Plus Dalpiciclib in Head and Neck Squamous Cell Carcinoma

NCT06199271 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-01-22

No results posted yet for this study

Summary

This study is a single arm phase II trial including 30 patients with III-IVB (according to the 8th edition of UICC/AJCC staging) locally advanced head and neck squamous cell carcinoma (HNSCC) eligible for resection, who receive Adebrelimab plus Dalpiciclib as neoadjuvant regimen before surgery.

This proposed study will evaluate the efficacy and safety of preoperative administration of Adebrelimab plus Dalpiciclib in HNSCC who are eligible for resection.

Conditions

Interventions

DRUG

Adebrelimab and dalpiciclib

Before surgery, the eligible patients received 3 cycles of adebrelimab (1200 mg intravenously every 3 weeks, Day 1, 22 and 43) and 2 cycles of dalpiciclib (150 mg, po, every 4 weeks, day 1-21 and 29-49). Administration dose adjustments were permitted according to the haematological or non-haematological toxicity.

Sponsors & Collaborators

  • Zhongzheng Xiang

    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
Yes

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2026-12-31
Completion
2026-12-31

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Entities

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 NCT06199271 on ClinicalTrials.gov