OncoMatch/Clinical Trials/NCT05125055
Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC
Is NCT05125055 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2/3 trial studies multiple treatments for oral squamous cell carcinoma.
Treatment: Toripalimab (anti-programmed death-1 inhibitor) · Albumin paclitaxel · Cisplatin · Docetaxel · 5-Fluorouracil — To 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage III, IVA
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
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.
Frequently asked questions
Is NCT05125055 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anticancer treatments, radiation therapy to head and neck disqualifies patients from enrollment.
What disease stage is eligible?
Stage III or IVA is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages