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

NCT04473716 | Completed Phase 1

• 1 other identifier: Illuminate trial
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cancer; Induction Chemotherapy; Programmed Cell Death 1 Inhibitor; Inductive Therapy

Outcome Measures

Primary Outcomes (1)

• Major pathological response

  Major pathological response is based on the pathological examination on the post-operative specimens after neoadjuvant therapy.

  One year

Secondary Outcomes (2)

• 2-year overall survival

  Two years

• 2-year tumor recurrence rate

  Two years

Study Arms (1)

Neoadjuvant therapy with Toripalimab, Paclitaxcel and Cisplatin

EXPERIMENTAL

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.

Drug: Toripalimab; Drug: Paclitaxcel; Drug: Cisplatin; Procedure: Radical surgery; Radiation: Post-operative radiotherapy/chemoradiotherapy

Interventions

Toripalimab DRUG

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

Also known as: Toripalimab for Injection

Neoadjuvant therapy with Toripalimab, Paclitaxcel and Cisplatin

Paclitaxcel DRUG

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

Also known as: Paclitaxel for Injection (Albumin Bound)

Neoadjuvant therapy with Toripalimab, Paclitaxcel and Cisplatin

Cisplatin DRUG

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

Also known as: Cisplatin for Injection

Neoadjuvant therapy with Toripalimab, Paclitaxcel and Cisplatin

Radical surgery PROCEDURE

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

Neoadjuvant therapy with Toripalimab, Paclitaxcel and Cisplatin

Post-operative radiotherapy/chemoradiotherapy RADIATION

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

Neoadjuvant therapy with Toripalimab, Paclitaxcel and Cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

• 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.

  PMID: 37288582 DERIVED

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

toripalimab; Injections; Paclitaxel; Cisplatin; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Combined Modality Therapy; Radiotherapy

Study Officials

• Lai-ping Zhong, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 16, 2020
• Study Start: July 30, 2020
• Primary Completion: April 12, 2021
• Study Completion: September 30, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

CN (1)