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

• Status: Recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Zhejiang University
• Treatments: Cetuximab; Cisplatin

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