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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
154

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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