Clinical trial

Toripalimab in Combination With Cetuximab，Cisplatin and 5-FU for Conversion Therapy of Locally Nonresectable Oral Cavity Squamous Cell Carcinoma （OCSCC）

Name

IIT20220085C-R1

Description

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.

Trial arms

Trial start

2023-07-06

Estimated PCD

2024-03-01

Trial end

2024-11-01

Status

Recruiting

Phase

Early phase I

Treatment

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

Arms:

Toripalimab plus Cetuximab，chemotherapy group

Other names:

Drug: Cetuximab, Drug: Cisplatin, Drug: 5-FU

Size

Primary endpoint

Major pathological response（MPR）

through study completion; an average of 1 year

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 33, 'type': 'ESTIMATED'}}

Updated at

2023-10-13

1 organization

1 product

1 indication

Organization

First Affiliated Hospital of Zhejiang University

Product

Toripalimab

Indication

Squamous Cell Carcinoma of Head and Neck