Inductive Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients

• Status: Active, not recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to use the combination of immune checkpoint inhibitor of Toripalimab, and chemotherapy agents of TP, as an inductive therapy to treat the patients with locally advanced OSCC, followed with radical surgery and post-operative radiotherapy/chemoradiotherapy, the major pathological response and safety will be evaluated as the primary surrogate endpoints, the 2-year survival rate and local recurrence rate will be the second endpoints.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Cisplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Eastern cooperative oncology group performance status (ECOG PS) score: 0-2 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 Criteria:

• 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