NCT05941338: HNC-SYSU-001

Tirelizumab in Combination With Carboplatin and Albumin-binding Paclitaxel for Neoadjuvant Therapy in HNSCC

Recruiting now Phase 2 Last updated 12 July 2023

What this trial tests

Phase 2 trial testing Tirelizumab ,+Carboplatin+albumin-bound paclitaxel in Head and Neck Squamous Cell Carcinoma in 100 participants. Currently enrolling.

Timeline

1 March 2023

Primary endpoint
28 February 2025

28 February 2030

Quick facts

Lead sponsor	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 March 2023
Primary completion	28 February 2025
Estimated completion	28 February 2030
Sites	1 location across China

Drugs / interventions tested

• Tirelizumab ,+Carboplatin+albumin-bound paclitaxel — full drug profile →

Conditions studied

• Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →
• Oral Cancer — all drugs for Oral Cancer →

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Who can join

Adults 18 to 65, any sex, with Head and Neck Squamous Cell Carcinoma or Oral Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this study, 100 patients with resectable head and neck squamous cell carcinoma (oral squamous cell carcinoma and oropharyngeal squamous cell carcinoma) were enrolled, who were combined with tirelizumab, carboplatin and albumin-binding paclitaxel before and after surgery. Tumor tissues and paracancer tissues of patients were collected to observe the imaging and pathological changes before and after treatment. At the same time, clinical information of patients, such as pathological grade, stage, treatment, prognosis, serology, imaging, etc. were collected to evaluate the safety and feasibility of tirelizumab combined with carboplatin and albumin-binding paclitaxel for neoadjuvant therapy of resectable oral and oropharyngeal squamous cell carcinoma. This is a prospective, one-arm, phase II clinical study.

Purpose Main purpose The efficacy of Tirelizumab combined with carboplatin and albumin-paclitaxel in neoadjuvant therapy for resectable head and neck squamous cell carcinoma was evaluated by calculating the major pathological response (MPR) rates in the experimental group.

The severity of adverse events associated with neoadjuvant therapy will be graded according to NCI CTCAE (version 5.0) during the course of this study and during follow-up, the incidence of adverse events in the experimental and control groups will be compared, and the safety of neoadjuvant therapy with Tirelizumab combined with carboplatin and albumin-paclitaxel in resectable head and neck squamous cell carcinoma will be evaluated.

Secondary Purpose

1. One-year event survival rate and event-free survival (EFS) of enrolled patients were evaluated (five years);
2. Pathological complete response rate (pCR) of enrolled patients was evaluated (5 years);
3. pTR of enrolled patients was evaluated;
4. Overall survival (OS) of enrolled patients was evaluated (5 years);
5. Radiological response of enrolled patients was assessed;
6. The rate of operation delay of enrolled patients was evaluated;

Publications & conference data

No peer-reviewed publications indexed yet for this trial.