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OncoMatch/Clinical Trials/NCT05125055

Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC

Is NCT05125055 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments for oral squamous cell carcinoma.

Phase 2/3RecruitingShanghai Jiao Tong University School of MedicineNCT05125055Data as of May 2026

Treatment: Toripalimab (anti-programmed death-1 inhibitor) · Albumin paclitaxel · Cisplatin · Docetaxel · 5-FluorouracilTo compare the pathological efficacy of neoadjuvant Toripalimab and Albumin paclitaxel /Cisplatin (TTP) with Docetaxel/ Cisplatin/ 5-flurouracil (TPF) for patients with locally advanced resectable oral squamous cell carcinoma (OSCC), and to determine the safety of neoadjuvant TTP. In order to explore a better protocol of neoadjuvant therapy to improve the efficacy in patients with locally advanced OSCC.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Disease stage

Required: Stage III, IVA

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: anticancer treatments

Exception: unless grade 2 or higher toxic reactions have resolved

Unresolved grade 2 (CTCAE 5.0) or higher toxic reactions caused by previous anticancer treatments

Cannot have received: radiation therapy to head and neck

Known history of radiation to head and neck

Lab requirements

Blood counts

WBCs >3,000/mm3, hemoglobin >8 g/L, platelets >80,000/mm3

Kidney function

Serum creatinine <1.5 times the upper limit of normal

Liver function

ALAT/ASAT <2.5 times the upper limit of normal and bilirubin <1.5 times the upper limit of normal

Blood routine: white blood cells (WBCs) >3,000/mm3, hemoglobin >8 g/L, platelets >80,000/mm3; Liver function: ALAT/ASAT <2.5 times the upper limit of normal and bilirubin <1.5 times the upper limit of normal; Renal function: Serum creatinine <1.5 times the upper limit of normal; Coagulation function: INR, PT, APTT<1.5 times the upper limit of normal

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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