Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial (SHINE)

January 19, 2026 updated by: Xuekui Liu, Sun Yat-sen University

A Randomized, Open-label, Multi-center Phase III Clinical Study of Toripalimab Combined With Cisplatin and Docetaxel Versus Toripalimab Alone as Neoadjuvant Therapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

This study compares two short pre-surgery treatments for locally advanced head and neck squamous cell cancer to see which one keeps the cancer from coming back longer.

Eligible patients (18-70 years, newly diagnosed, operable) will be randomly assigned to receive either toripalimab (immunotherapy) alone or toripalimab plus two cycles of chemotherapy (docetaxel and cisplatin). After the two cycles, all patients will have standard surgery followed by radiation (or chemo-radiation).

We will track tumor response, side effects, and quality of life. Possible benefits: tumor shrinkage and lower chance of recurrence; possible risks: low blood counts, rash, tiredness, or other drug-related side effects.

Taking part is voluntary and you can leave the study at any time.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

154

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pathologically confirmed, newly diagnosed, non-metastatic, operable locally advanced head-and-neck squamous cell carcinoma (oral cavity, larynx, hypopharynx, or oropharynx) Stage III-IVA (p16-positive oropharynx T4N0-N2; p16-negative oropharynx III-IVA; larynx/hypopharynx/oral cavity III-IVA) PD-L1 CPS ≥ 1 Age 18-70 years ECOG performance status 0-1 Adequate organ function (ANC ≥ 2.0×10⁹/L, platelets ≥ 100×10⁹/L, TBIL < 1.5×ULN, ALT/AST < 1.5×ULN, creatinine < 1.5×ULN) No prior head-and-neck cancer surgery or radiotherapy No other malignancy within 5 years Signed informed consent

Exclusion Criteria:

  • Previous systemic anti-cancer therapy for head-and-neck cancer Known hypersensitivity to study drugs Active or untreated hepatitis B/C, HIV positivity Severe cardiac, pulmonary, liver, or renal insufficiency precluding surgery Pregnancy or lactation Psychiatric or social conditions preventing compliance Organ transplant on chronic immunosuppression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Toripalimab monotherapy
Participants receive two 3-week cycles of toripalimab 240 mg IV before undergoing radical surgery, followed by post-operative radiotherapy or chemoradiotherapy plus 12 additional cycles of toripalimab.
Drug: Toripalimab
Humanised anti-PD-1 IgG4κ monoclonal antibody. 240 mg IV infusion Day 1 of each 21-day cycle for 2 neoadjuvant cycles, then 3 cycles concurrent with post-op radiotherapy/chemoradiotherapy, followed by 12 adjuvant cycles every 3 weeks.
Experimental: Toripalimab + chemotherapy
Participants receive two 3-week cycles of toripalimab 240 mg IV combined with docetaxel 75 mg/m² and cisplatin 75 mg/m² before radical surgery, followed by post-operative radiotherapy or chemoradiotherapy plus 12 additional cycles of toripalimab.
Drug: Toripalimab
Humanised anti-PD-1 IgG4κ monoclonal antibody. 240 mg IV infusion Day 1 of each 21-day cycle for 2 neoadjuvant cycles, then 3 cycles concurrent with post-op radiotherapy/chemoradiotherapy, followed by 12 adjuvant cycles every 3 weeks.
Drug: Docetaxel and Cisplatin
Neoadjuvant chemotherapy: docetaxel 75 mg/m² IV Day 1 + cisplatin 75 mg/m² IV Day 1, repeated every 21 days for 2 cycles, given together with toripalimab in the combination arm.
Other Names:
  • Taxotere；Platinol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year Event-Free Survival
Time Frame: From randomisation to 24 months
Proportion of patients alive and free from locoregional recurrence, distant metastasis, second primary tumor, or death from any cause within 24 months after randomisation, assessed per modified RECIST 1.1.
From randomisation to 24 months
2-year Event-Free Survival (EFS)
Time Frame: From randomisation to 24 months
Proportion of patients alive and free from locoregional recurrence, distant metastasis, second primary tumor, or death from any cause within 24 months after randomisation, assessed per modified RECIST 1.1.
From randomisation to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

January 19, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSUCC-HN-2024-SHINE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head and Neck Squamous Cell Carcinoma HNSCC

Clinical Trials on Toripalimab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe