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

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Brief Title

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

Official Title

Neoadjuvant Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients: A Single-arm Phase I Trial

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, 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.

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 therapy can reduce tumor burden, increase organ preservation rate,
      and reduce distant metastasis rate. Pre-operative neoadjuvant therapy with paclitaxcel and
      cisplatin (TP) has been used as one of recommended protocols in patients with locally
      advanced head and neck squamous cell caricnoma, including OSCC. Anti-PD1/PD-L1
      immunotherapies have achieved exciting clinical outcomes in several malignancies, such as
      lung cancer, breast cancer, and so on. Recently, pre-operative neoadjuvant therapy with
      combination of immunotherapy and chemotherapy agents has been used with good pathological
      response, which might transfer to good clinical prognosis in patients with malignancies.
      However, pre-operative neoadjuvant therapy with combination of anti-PD1 and TP in OSCC
      patients has not been reported. The innovation of this study is 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, 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.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Major pathological response

Secondary Outcome

 2-year overall survival

Condition

Oral Cancer

Intervention

Toripalimab

Study Arms / Comparison Groups

 Neoadjuvant therapy with Toripalimab, Paclitaxcel and Cisplatin
Description:  Pre-operative neoadjuvant therapy will be used with the combination of immune checkpoint inhibitor of Toripalimab, and chemotherapy agents of paclitaxcel and cisplatin in patients with locally advanced OSCC. After inductive therapy, the patients will receive radical surgery and post-operative radiotherapy/chemoradiotherapy.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

20

Start Date

July 30, 2020

Completion Date

September 30, 2023

Primary Completion Date

April 12, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  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 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

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Lai-ping Zhong, MD, PhD, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT04473716

Organization ID

Illuminate trial

Responsible Party

Principal Investigator

Study Sponsor

Shanghai Jiao Tong University School of Medicine

Study Sponsor

Lai-ping Zhong, MD, PhD, Principal Investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Verification Date

October 2022