Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Jiao Tong University School of Medicine
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Toripalimab (anti-programmed death-1 inhibitor)
- Albumin paclitaxel
- Cisplatin
- Docetaxel
- 5-Fluorouracil
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov