Neoadjuvant immunotherapy and chemotherapy for advanced oral cancer
A Multi-Center, Randomized Phase III Study of Neoadjuvant Anti-PD-1 Immunotherapy Plus TP Chemotherapy Versus TP Chemotherapy or Up-Front Surgery in Resectable Locally Advanced Oral Squamous Cell Carcinoma
This study is testing whether combining a new immune therapy with chemotherapy can help people with advanced oral cancer live longer compared to just chemotherapy or surgery alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 309 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Hospital of Stomatology, Wuhan University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 3 sites (Shenzhen, Guangdong and 2 other locations) |
| Trial ID | NCT05798793 on ClinicalTrials.gov |
What this trial studies
This study investigates the survival benefits of combining neoadjuvant anti-PD-1 immunotherapy with TP chemotherapy in patients with resectable locally advanced oral squamous cell carcinoma. It aims to compare this combination treatment to TP chemotherapy alone or to upfront surgery. The study will also explore changes in immune cell profiles and functions in tumors, lymph nodes, and peripheral blood, assessing their correlation with patient responses and prognoses. The research is designed to provide insights into the efficacy and safety of this treatment approach.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically confirmed locally advanced oral squamous cell carcinoma who are eligible for surgical resection.
Not a fit: Patients with distant metastasis or those who do not meet the specified organ function criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates for patients with advanced oral squamous cell carcinoma.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically documented oral squamous cell carcinoma (biopsy required). 2. Local advanced oral squamous cell carcinoma (clinical stage T1-2N1-2M0, T3-4aN0-2M0) with resection option for potential cure, as assessed by a faculty surgeon at Hospital of Stomatology, Wuhan University. 3. Distant metastasis is excluded by chest CT and emission computed tomograph. 4. Adequate organ function as follows: 1) Leukocyte count ≥ 2,000/mm3; 2) Absolute neutrophil count ≥ 1,000/mm3; 3) Platelet count ≥ 100,000/mm3; 4) Hemoglobin ≥ 90 g/L; 5) Serum albumin ≥30 g/L; 6) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); 7) AST (SGOT) and ALT (SGPT) \< 2.5 × ULN; 8) ALP ≤ 2.5 × ULN; 9) Prothrombin time-international normalized ratio ≤ 1.5; 10) Serum creatinine ≤ 1.5 × ULN; 11) INR/PT≤ 1.5; 12) TSH ≤ ULN. 5. ECOG performance status 0-1. 6. Female patient tested HCG negative in serum or urine within 7 days prior to the start of investigational product. Both patient and partner must agree to use contraception prior to study entry and for the duration of study participation and for up to 120 days after the last dose of PD-1 blockade. 7. Patient understands the study regimen, its requirements, risks and discomforts and is able and willing to sign the informed consent form. Exclusion Criteria: 1. History of ≥ 3 grade immune related adverse events (irAEs) or have not recovered to ≤ 1 grade irAEs from previous treatment. 2. History of other treatments for cancer, including surgery, chemotherapy, radiotherapy or molecular targeted therapy within past 5 years. 3. Previous therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 or any other antibody targeting T cell co-regulatory pathways. 4. Active autoimmune disease or history of refractory autoimmune disease. 5. Active systemic infection requiring therapy. 6. Patients who are receiving psychotropic drug or alcohol/drug abuse. 7. Subjects with concurrent other active malignancies. 8. HIV or untreated active HBV or HCV infections, or vaccinated (HBV, flu, varicella, etc) within 4 weeks before recruitment. 9. Uncontrollable systemic diseases, including diabetes, hypertension, etc. 10. History of stroke or transient ischemic attack within past 6 months. 11. Distant metastases or inability to resect after physician evaluation. 12. Serious cardiovascular, respiratory, immune system critical disease or other conditions that the researchers thought might increase the subjects' risk.
Where this trial is running
Shenzhen, Guangdong and 2 other locations
- Peking university Shenzhen hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
- Hospital of Stomatology, Wuhan University — Wuhan, Hubei, China (Recruiting)
- Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Principal investigator: Gang Chen, M.D. — Hospital of Stomatology, Wuhan University
- Study coordinator: Gang Chen, M.D.
- Email: geraldchan@whu.edu.cn
- Phone: +86 02787686215
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.