RecruitingPhase 1Phase 2NCT06494943

Induction IBI110 and Sintilimab with Chemotherapy in LA HNSCC

Neoadjuvant IBI110 and Sintilimab in Combination with Chemotherapy in Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)- a Phase Ib Clinical Trial


Sponsor

Fudan University

Enrollment

27 participants

Start Date

Jun 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to investigate the efficacy and safety of combining sintilimab and the TP regimen with/without IBI110 for neoadjuvant chemotherapy in resectable locally advanced head and neck squamous cell carcinoma (HNSCC).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding two immunotherapy drugs (IBI110 and sintilimab) to standard induction chemotherapy before surgery can improve outcomes for people with resectable, locally advanced head and neck squamous cell carcinoma. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with locally advanced squamous cell carcinoma of the head and neck (including the oropharynx, oral cavity, larynx, or hypopharynx) that can be surgically removed - Your cancer is Stage III to IVB - You have at least one measurable tumor lesion - You are in good physical condition (ECOG 0–1) - Your expected survival is more than 3 months **You may NOT be eligible if...** - Your cancer has already spread to distant organs - You have previously received treatment for this cancer - You have serious autoimmune disease or active infections - 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

DRUGSintilimab

PD-1 inhibitor

DRUGIBI110

LAG-3 inhibitor

DRUGPaclitaxel

Chemotherapy

DRUGCis Platinum

Chemotherapy

PROCEDURESurgery

Definitive surgery

RADIATIONAdjuvant radiation

Adjuvant radiotherapy or chemoradiotherapy based on post-operative pathologic findings.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06494943


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