Sequential Toripalimab and Paclitaxel in Patients With Head and Neck Squamous Cell Cancer (HNSCC) and Poor Performance Status

Summary

The goal of this clinical trial is to learn if the drug Toripalimab can prime the tumor to optimize response to Paclitaxel in HNSCC patients with a decrease performance status in a way that make both drugs well tolerated and improve partial or complete response rate over each treatment. The main questions it aims to answer are:

* What is the response rate of the cancer to paclitaxel after priming with toripalimab
* What is the time to progression if we continue to cycle between toripalimab and paclitaxel
* What is the impact on the patient's quality of life and overall survival

Conditions

• Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Interventions

DRUG

Toripalimab

Toripalimab 240mg intravenously every three weeks on weeks 1, 4 and 7 of a 17 week cycle.

DRUG

Paclitaxel

Paclitaxel 80mg/m2 intravenously over weekly for 8 weeks on weeks 8-15 of each cycle times 3 cycles

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute

  lead OTHER

Principal Investigators

• Ammar Sukari, M.D. · Barbara Ann Karmanos Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2028-05-29

Completion

2029-05-29

FDA Drug

Yes

Countries

• United States

Study Locations