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

Sun Yat-sen University

Status and phase: Begins enrollment in 4 months; Phase 3

Conditions: Head and Neck Squamous Cell Carcinoma HNSCC

Treatments: Drug: Toripalimab; Drug: Docetaxel and Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT07371897

SYSUCC-HN-2024-SHINE

Details and patient eligibility

About

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.

Enrollment: 154 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

154 participants in 2 patient groups

Toripalimab monotherapy

Experimental group

Description:

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.

Treatment:

Drug: Toripalimab

Toripalimab + chemotherapy

Experimental group

Description:

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.

Treatment:

Drug: Docetaxel and Cisplatin

Drug: Toripalimab