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Neoadjuvant Toripalimab or Toripalimab in Combination With Carboplatin and Nab-paclitaxel in Untreated HNSCC (HNSCC-002)

NCT04807140 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2023-04-14

No results posted yet for this study

Summary

This proposed study will evaluate the efficacy and safety of preoperative administration of Toripalimab or Toripalimab combined with nab-paclitaxel and carboplatin in Head and Neck Squamous Cell Carcinoma (HNSCC) who are about to undergo surgery，and it will be helpful for comprehensive exploratory characterization of tumor immune microenvironment and circulating immune cells in these patients. Data obtained in this trial will provide valuable information for planning further prospective clinical trials of anti-PD-1 and other immunotherapies in HNSCC. We are also eager to identify potential biomarkers of response and toxicity that will enable patients with HNSCC who are most likely to benefit to receive anti-PD-1 therapy and, to the contrary, reduce the risk of toxicity and ineffective therapy in patients who are less likely to benefit from it.

Conditions

Interventions

DRUG

Toripalimab, nab-paclitaxel, carboplatin

Patients receive Toripalimab IV on day 1, nab-paclitaxel IV on day 1 and carboplatin IV on day 1. Treatment repeats every 21 days for up to 2-4 courses in the absence of disease progression or unacceptable toxicity.

DRUG

Toripalimab

Patients receive Toripalimab IV on day 1. Treatment repeats every 21 days for up to 2-4 courses in the absence of disease progression or unacceptable toxicity.

PROCEDURE

Surgical resection

Surgical therapy will be at the discretion of the treating surgeon per standard of care.

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-08
Primary Completion
2023-12-01
Completion
2027-01-01

Countries

  • China

Study Locations

More Related Trials

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 NCT04807140 on ClinicalTrials.gov