Status:
COMPLETED
Neoadjuvant Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Oral Cancer
Induction Chemotherapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The aim of this study is to use the combination of immune checkpoint inhibitor of Toripalimab, and chemotherapy agents of TP, as a neoadjuvant therapy to treat the patients with locally advanced OSCC,...
Detailed Description
In patients with locally advanced oral squamous cell carcinoma (OSCC), comprehensive treatment is recommended, including surgery, radiotherapy, chemotherapy and others. Pre-operative neoadjuvant thera...
Eligibility Criteria
Inclusion
- Eastern cooperative oncology group performance status (ECOG PS) score: 0-1 points
- Pathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheeks, mouth floor, hard palate, posterior molar region)
- Clinical stage of III/IVA (AJCC 2018)
- Blood routine: white blood cells \> 3,000/mm3, hemoglobin \> 8g/L, platelets \> 80,000/mm3
- Liver function: Alanine Transaminase/Aspartate Transaminase \<2.5 times the upper limit of normal, bilirubin \<1.5 times the upper limit of normal
- Renal function: serum creatinine \<1.5 times the upper limit of normal
- Sign the informed consent
Exclusion
- There are still unresolved toxic reactions above CTCAE level 2 caused by previous anti-cancer treatment
- Grade 3-4 allergic reactions to Toripalimab, paclitaxcel or cisplatin
- Active severe clinical infection (\> CTCAE 5.0 version 2 infection)
- Difficult to control hypertension or cardiovascular disease with clinical significance (such as activity)-such as cerebrovascular accident (\< 6 months before treatment), myocardial infarction (\< 6 months before treatment), unstable angina, New York Cardiology Society (NYHA Appendix 5) congestive heart failure grade II or above, or severe arrhythmia that cannot be controlled with drugs or has potential impact on experimental treatment
- Chronic diseases requiring immunotherapy or hormone therapy
- Women during pregnancy or lactation
- Participated in other clinical studies within 30 days before enrollment
- Other circumstances that the investigator thinks are not suitable for participating in the study
Key Trial Info
Start Date :
July 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04473716
Start Date
July 30 2020
End Date
September 30 2023
Last Update
November 22 2023
Active Locations (1)
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1
Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China