Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC (NCT05125055) | Clinical Trial Compass
RecruitingPhase 2/3
Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC
China80 participantsStarted 2021-10-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age: 18-75 years old
✓. Gender: male and female
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-2
✓. Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)
✓. Primary tumor with a clinical stage of III/IVA (T1-2/N1-2/M0 or T3-4a/cN0-2/M0, AJCC2018)
✓. Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
✓. Liver function: alanine amino transferase/aspartate amino transferase (ALAT/ASAT) \<2.5 times the upper limit of normal and bilirubin \<1.5 times the upper limit of normal
Exclusion criteria
✕. Unresolved grade 2 \[(Common Terminology Criteria for Adverse Events (CTCAE 5.0)\] or higher toxic reactions caused by previous anticancer treatments
✕. Known allergic reaction to any ingredients or excipients of the therapy
✕. Known history of malignancy, unless been cured and no recurrence for 5 years
✕. Known history of radiation to head and neck
What they're measuring
1
Major pathologic response
Timeframe: 3 months
Trial details
NCT IDNCT05125055
SponsorShanghai Jiao Tong University School of Medicine
✕. Active severe clinical infection (\> National Cancer Institute (NCI)-CTCAE version 5.0 grade 2 infection)
✕. Obvious cardiovascular abnormalities \[such as myocardial infarction, superior vena cava syndrome, grade 2 or higher heart disease diagnosed according to the New York Heart Association (NYHA) classification 3 months before enrollment\]
✕. Patients receiving immunology-based treatment for any reason
✕. Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy