Status:
UNKNOWN
Toripalimab in Combined With Cetuximab，Chemotherapy for Conversion Therapy of Locally Nonresectable OCSCC
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Conditions:
Squamous Cell Carcinoma of Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 combi...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06081582
Start Date
July 6 2023
End Date
November 1 2024
Last Update
October 13 2023
Active Locations (1)
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1
Department of Medical Onocology, First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310003