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

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

NCT ID: NCT06081582

Condition: Squamous Cell Carcinoma of Head and Neck

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Cisplatin
Cetuximab

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Toripalimab
Description: 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
Arm group label: Toripalimab plus Cetuximab，chemotherapy group

Other name: Drug: Cetuximab

Other name: Drug: Cisplatin

Other name: Drug: 5-FU

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.

Criteria for 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 - Exclusion criteria related to concomitant medications - Participated in other clinical trials within four weeks - Have received preventive or attenuated vaccines within 4 weeks before the first administration

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Department of Medical Onocology, First Affiliated Hospital of Zhejiang University

Address:
City: Hangzhou
Zip: 310003
Country: China

Status: Recruiting

Contact:
Last name: Yulong Zheng, MD

Phone: 13588166206
Email: drzhengyu@126.com

Contact backup:
Last name: CHENG XIAO, MD

Phone: 87235896
Email: 21218159@zju.edu.cn

Start date: July 6, 2023

Completion date: November 2024

Lead sponsor:
Agency: First Affiliated Hospital of Zhejiang University
Agency class: Other

Source: First Affiliated Hospital of Zhejiang University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06081582