RecruitingPhase 1NCT06109207

Neoadjuvant Camrelizumab With Dalpiciclib for Resectable Head and Neck Squamous Cell Carcinomas

The Safety and Feasibility of Neoadjuvant Camrelizumab With Dalpiciclib for the Treatment of Resectable Head and Neck Squamous Cell Carcinoma:A Phase 1 Trial


Sponsor

West China Hospital

Enrollment

6 participants

Start Date

Oct 31, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to explore the safety and feasibility of anti-programmed cell death protein 1(PD-1) immunotherapy, Camrelizumab, combined with cyclin-dependent kinase 4/6 blockade, Dalpiciclib, as a new neoadjuvant treatment regimen for patients with resectable head and neck squamous cell carcinoma(HNSCC).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two drugs — camrelizumab (an immunotherapy) and dalpiciclib (a targeted therapy) — given before surgery (neoadjuvant treatment) in patients with head and neck squamous cell carcinoma that can be surgically removed. **You may be eligible if...** - You are 18 or older with a newly diagnosed, surgically removable head and neck squamous cell carcinoma (not nasopharyngeal cancer) - Your cancer has not spread to distant parts of the body - You are willing to undergo surgery - Your blood counts and organ function are in acceptable range **You may NOT be eligible if...** - You have had other cancers in the past 5 years (some minor skin cancers may be OK) - You have an active autoimmune disease requiring systemic treatment - You have had prior immunotherapy, anti-EGFR therapy, or other targeted cancer treatments - You have significant heart problems, uncontrolled diabetes or high blood pressure, or active infections including HIV, hepatitis B or C - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCamrelizumab

Camrelizumab will be given at at a dose of 200 mg intravenously every three weeks on day 1 of a planned 21-day cycle, and two doses before surgery

DRUGDalpiciclib 100mg

Dalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.

DRUGDalpiciclib 150mg

Dalpiciclib will be given at a dose of 150 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.


Locations(1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

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NCT06109207


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