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.
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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

Lai-ping Zhong, MD, PhD

+862123271699

zhonglp@hotmail.com

CONTACT