Comparing two treatment approaches for advanced oral squamous cell carcinoma

Neoadjuvant Toripalimab and Albumin Paclitaxel /Cisplatin Versus Docetaxel/ Cisplatin/ 5-fluorouracil (TPF) on Pathological Response in Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma

This study is testing whether a new combination treatment for advanced oral cancer can work better than the standard treatment to help patients before surgery.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Jiao Tong University School of Medicine (Academic / other)
• Drugs / interventions: radiation, Toripalimab, chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05125055 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of neoadjuvant therapy using Toripalimab combined with Albumin paclitaxel and Cisplatin (TTP) against the standard Docetaxel, Cisplatin, and 5-Fluorouracil (TPF) regimen in patients with locally advanced resectable oral squamous cell carcinoma (OSCC). The study will enroll 80 patients and assess the major pathological response (MPR) rate as the primary endpoint. Participants will receive two cycles of the assigned treatment before undergoing surgery and postoperative adjuvant therapy. The trial builds on previous findings that indicated a promising MPR rate with the TTP regimen.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a diagnosis of locally advanced resectable oral squamous cell carcinoma.

Not a fit: Patients with non-resectable tumors or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could lead to improved treatment outcomes for patients with advanced oral squamous cell carcinoma.

How similar studies have performed: Previous studies have shown promising results with neoadjuvant anti-PD-1 therapies, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Age: 18-75 years old
2. Gender: male and female
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-2
4. Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)
5. Primary tumor with a clinical stage of III/IVA (T1-2/N1-2/M0 or T3-4a/cN0-2/M0, AJCC2018)
6. Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
7. Blood routine: white blood cells (WBCs) \>3,000/mm3, hemoglobin \>8 g/L, platelets \>80,000/mm3
8. Liver function: alanine amino transferase/aspartate amino transferase (ALAT/ASAT) \<2.5 times the upper limit of normal and bilirubin \<1.5 times the upper limit of normal
9. Renal function: Serum creatinine \<1.5 times the upper limit of normal
10. Coagulation function: INR, PT, APTT\<1.5 times the upper limit of normal
11. Signed the informed consent form

Exclusion Criteria:

1. Unresolved grade 2 \[(Common Terminology Criteria for Adverse Events (CTCAE 5.0)\] or higher toxic reactions caused by previous anticancer treatments
2. Known allergic reaction to any ingredients or excipients of the therapy
3. Known history of malignancy, unless been cured and no recurrence for 5 years
4. Known history of radiation to head and neck
5. Active severe clinical infection (\> National Cancer Institute (NCI)-CTCAE version 5.0 grade 2 infection)
6. Obvious cardiovascular abnormalities \[such as myocardial infarction, superior vena cava syndrome, grade 2 or higher heart disease diagnosed according to the New York Heart Association (NYHA) classification 3 months before enrollment\]
7. Patients receiving immunology-based treatment for any reason
8. Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy
9. Pregnant or lactating women
10. Uncontrollable hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>90 mmHg) or cardiovascular diseases with clinical significance (such as activity), such as cerebrovascular accidents (≤ 6 months before screening), myocardial infarction (≤6 months before screening), unstable angina pectoris, NYHA grade II or above congestive heart failure, or severe arrhythmia that cannot be controlled by drugs or has a potential impact on trial treatment
11. Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or solid organ transplantation
12. Participation in other clinical trials within 30 days before enrollment
13. Other situations that the investigator considers unsuitable with respect to participating in the trial

Where this trial is running

Shanghai, Shanghai Municipality

• Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Lai-ping Zhong, MD, PhD

Conditions Oral Squamous Cell Carcinoma; Neoadjvant Therapy; Anti-PD-1; Chemotherapy