Combining toripalimab with cetuximab and chemotherapy for advanced oral cancer treatment
Toripalimab in Combination With Cetuximab，Cisplatin and 5-FU for Conversion Therapy of Locally Nonresectable Oral Cavity Squamous Cell Carcinoma （OCSCC）
This study is testing a new combination of treatments, including toripalimab, cetuximab, and chemotherapy, to see if it can help people with advanced oral cancer who can't have surgery feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Drugs / interventions | toripalimab, cetuximab, chemotherapy, immunotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06081582 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial aims to evaluate the efficacy and safety of the PD-1 inhibitor toripalimab in combination with cetuximab, cisplatin, and 5-FU for patients with locally advanced oral squamous cell carcinoma (OCSCC) that is initially unresectable. The study will enroll 33 patients and focuses on innovative treatment methods to improve outcomes for those who cannot undergo surgery. By assessing the potential for achieving a pathological complete response (pCR) or major pathological response (MPR), the trial seeks to enhance overall survival (OS) and disease-free survival (DFS) rates in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed squamous cell carcinoma of the tongue, floor of mouth, gingiva, or buccal area at initial NCCN TNM stage III or IVA.
Not a fit: Patients with active autoimmune diseases, central nervous system metastasis, or those who have received significant surgical treatment recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could provide a new effective option for patients with advanced oral squamous cell carcinoma that cannot be surgically removed.
How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and chemotherapy in treating non-surgical head and neck cancers, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hangzhou, Zhejiang
- Department of Medical Onocology, First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Yulong Zheng, MD — First Affiliated Hospital of Zhejiang University
- Study coordinator: Yulong Zheng, MD
- Email: drzhengyu@126.com
- Phone: 13588166206
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.