MedDataX Logo

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

NCT ID: NCT04473716

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-30

Study Completion Date

2023-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Cancer Induction Chemotherapy Programmed Cell Death 1 Inhibitor Inductive Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Neoadjuvant therapy with Toripalimab, Paclitaxcel and Cisplatin

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.

Group Type EXPERIMENTAL

Toripalimab

Intervention Type DRUG

Neoadjuvant therapy with Toripalimab of 240mg, iv, qd, on day 1, 22

Paclitaxcel

Intervention Type DRUG

Neoadjuvant therapy with Paclitaxcel of 260mg/m2, iv, qd, on day 1, 22

Cisplatin

Intervention Type DRUG

Neoadjuvant therapy with Cisplatin of 75mg/m2, iv, qd, on day 1, 22

Radical surgery

Intervention Type PROCEDURE

Radical surgery will be performed on the 43th-48th after initiation of inductive therapy.

Post-operative radiotherapy/chemoradiotherapy

Intervention Type RADIATION

Post-operative radiotherapy/chemoradiotherapy will be performed within 1.5 months after radical surgery, depending on the post-operative pathological diagnosis.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Toripalimab

Neoadjuvant therapy with Toripalimab of 240mg, iv, qd, on day 1, 22

Intervention Type DRUG

Paclitaxcel

Neoadjuvant therapy with Paclitaxcel of 260mg/m2, iv, qd, on day 1, 22

Intervention Type DRUG

Cisplatin

Neoadjuvant therapy with Cisplatin of 75mg/m2, iv, qd, on day 1, 22

Intervention Type DRUG

Radical surgery

Radical surgery will be performed on the 43th-48th after initiation of inductive therapy.

Intervention Type PROCEDURE

Post-operative radiotherapy/chemoradiotherapy

Post-operative radiotherapy/chemoradiotherapy will be performed within 1.5 months after radical surgery, depending on the post-operative pathological diagnosis.

Intervention Type RADIATION

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Toripalimab for Injection Paclitaxel for Injection (Albumin Bound) Cisplatin for Injection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lai-ping Zhong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lai-ping Zhong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Huang Y, Sun J, Li J, Zhu D, Dong M, Dou S, Tang Y, Shi W, Sun Q, Zhao T, Zhou Z, Zhou X, Liu Y, Li J, Zhu G, Zhang D, Chen Y, Zhu Q, Ju W, Zhong L. Neoadjuvant immunochemotherapy for locally advanced resectable oral squamous cell carcinoma: a prospective single-arm trial (Illuminate Trial). Int J Surg. 2023 Aug 1;109(8):2220-2227. doi: 10.1097/JS9.0000000000000489.

Reference Type DERIVED
PMID: 37288582 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Illuminate trial

Identifier Type: -

Identifier Source: org_study_id