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

NCT ID: NCT06081582

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-06
• Study Completion Date: 2024-11-30

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.

Detailed Description

In the past decade, the treatment plan for non-surgical locally advanced HNSCC patients who are suitable for receiving synchronous radiotherapy and chemotherapy has remained unchanged, and innovative treatment methods are urgently needed. Based on the above research, immunotherapy combined with chemotherapy and immunotherapy combined with cetuximab have good efficacy and safety in non-surgical HNSCC patients. Therefore, combining PD-L1 antibodies with chemotherapy, surgery to further improve the efficacy of comprehensive treatment may become a new direction in tumor treatment. The achievement of pCR or MPR in conversion therapy is related to better OS and DFS outcomes in patients. In the era of immunotherapy, conversion therapy centered around surgery has become a hot topic in the field of treatment for locally advanced oral squamous cell carcinoma that cannot be surgically removed upon initial diagnosis.

There is no particularly preferred standard conversion chemotherapy regimen for patients with locally advanced head and neck squamous cell carcinoma that cannot be surgically removed initially. The combination of PD-1 inhibitor toripalimab, cetuximab, and chemotherapy may benefit the efficacy of these patients. Therefore, this prospective phase II clinical trial was designed to evaluate the efficacy and safety of PD-1 inhibitor toripalimab combined with chemotherapy and cetuximab conversion therapy in locally advanced oral squamous cell carcinoma patients who were initially unresectable.

Conditions

Squamous Cell Carcinoma of Head and Neck

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Toripalimab plus Cetuximab，chemotherapy group

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

Group Type: EXPERIMENTAL

Toripalimab

Intervention Type: 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

Interventions

Toripalimab

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

Intervention Type: DRUG

Other Intervention Names

Drug: Cetuximab; Drug: Cisplatin; Drug: 5-FU

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Yulong Zheng

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yulong Zheng, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Locations

Department of Medical Onocology, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yulong Zheng, MD

Role: CONTACT

drzhengyu@126.com

13588166206

CHENG XIAO, MD

Role: CONTACT

21218159@zju.edu.cn

87235896

Facility Contacts

Yulong Zheng, MD

Role: primary

drzhengyu@126.com

13588166206

CHENG XIAO, MD

Role: backup

21218159@zju.edu.cn

87235896

Other Identifiers

IIT20220085C-R1

Identifier Type: -

Identifier Source: org_study_id