Toripalimab in Combined With Cetuximab，Chemotherapy for Conversion Therapy of Locally Nonresectable OCSCC

NCT06081582 | Unknown Phase 2

• 1 other identifier: IIT20220085C-R1
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single center phase II clinical study with a planned enrollment of 33 patients. The main objective is to evaluate the efficacy and safety of the PD-1 inhibitor toripalimab combined with cetuximab, cisplatin, and 5-FU regimen in the treatment of locally advanced oral squamous cell carcinoma patients who are initially unresectable.

Conditions

Squamous Cell Carcinoma of Head and Neck

Outcome Measures

Primary Outcomes (1)

• Major pathological response（MPR）

  To determine the major pathological response rate, defined as \<10% viable tumor in the resection specimen, after two cycles of neoadjuvant Toripalimab Plus Cetuximab，Cisplatin and 5-FU in patients with Nonresectable Oral Cavity Squamous Cell Carcinoma （OCSCC）

  through study completion; an average of 1 year

Study Arms (1)

Toripalimab plus Cetuximab，chemotherapy group

EXPERIMENTAL

All subjects received 2-cycle conversion therapy with the PD-1 inhibitor toripalimab combined with cetuximab, cisplatin, and 5-FU The dosage of medication used is as follows: Toripalimab: 240mg, Day1, Q3W；Cisplatin: 25mg/m2, Day1-3, Q3W；5-FU: 1000mg/m2, Day1-3, Q3W Cetuximab Day 1, 8, 15, Q3W, 400 mg/m2 initial dose; Afterwards, 250 mg/m2 per week

Drug: Toripalimab

Interventions

Toripalimab DRUG

This study was conducted on 30 patients with initially unresectable locally advanced head and neck squamous cell carcinoma who underwent two cycles of PD-1 antibody (trepril monoclonal antibody) combined with fluorouracil, cisplatin, and cetuximab conversion therapy. The feasibility of radical surgery should be evaluated before surgical treatment.Three patients were enrolled in the safe induction period before the study began. The dosage of medication used is as follows: Toripalimab: 240mg, Day1, Q3W Cisplatin: 25mg/m2, Day1-3, Q3W（every 3 weeks） 5-FU: 1000mg/m2, Day1-3, Q3W Cetuximab Day 1, 8, 15, Q3W, 400 mg/m2 initial dose; Afterwards, 250 mg/m2 per week

Also known as: Drug: Cetuximab, Drug: Cisplatin, Drug: 5-FU

Toripalimab plus Cetuximab，chemotherapy group

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed squamous cell carcinoma of tongue, floor of mouth, gingival, buccal
• Initial NCCN TNM stage III and IVA patients
• PS score 0-1 points
• Age≥18 years old
• Measurable lesions that meet RECIST 1.1 standards
• Normal function of important organs
• All patients must provide tissue specimens

You may not qualify if:

• Active, known or suspected autoimmune disease patients
• According to the judgment of the researcher, there are accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study by the patients
• Merge with other malignant tumors
• Subjects with known central nervous system metastasis and/or cancerous meningitis
• Uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage
• Received significant surgical treatment or obvious traumatic injury within the first 28 days of randomization
• Have experienced arterial/venous thrombotic events within the first 6 months of randomization, such as cerebrovascular accidents
• Individuals with a history of abuse of psychotropic substances who are unable to quit or have mental disorders
• Subjects with any severe and/or uncontrollable diseases
• Participated in other clinical trials within four weeks
• Have received preventive or attenuated vaccines within 4 weeks before the first administration

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

Department of Medical Onocology, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

toripalimab; Cetuximab; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yulong Zheng, MD

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yulong Zheng, MD

CONTACT

13588166206; drzhengyu@126.com

CHENG XIAO, MD

CONTACT

87235896; 21218159@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: October 7, 2023
• First Posted: October 13, 2023
• Study Start: July 6, 2023
• Primary Completion: March 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)