Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC
Recruiting
Phase 2
Phase 3
Interventional Study
Oral Squamous Cell Carcinoma
Neoadjvant Therapy
Anti-PD-1
Chemotherapy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 80 (estimated)
- Sponsor
- Shanghai Jiao Tong University School of Medicine · Other
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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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age: 18-75 years old
2. Gender: male and female
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-2
4. Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)
5.…
Contacts