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Compares treatment options for Oral Squamous Cell Carcinoma
Official title Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC
ClinicalTrials.gov ID: NCT05125055
What this study is testing
What is Toripalimab (anti-programmed death-1 inhibitor)?
Toripalimab (anti-programmed death-1 inhibitor) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for oral squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To compare the pathological efficacy of neoadjuvant Toripalimab and Albumin paclitaxel /Cisplatin (TTP) with Docetaxel/ Cisplatin/ 5-flurouracil (TPF) for patients with locally advanced resectable oral squamous cell carcinoma (OSCC), and to determine the safety of neoadjuvant TTP. In order to explore a better protocol of neoadjuvant therapy to improve the efficacy in patients with locally advanced OSCC.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age: 18-75 years old
- Gender: male and female
- Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-2
- Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)
- Primary tumor with a clinical stage of III/IVA (T1-2/N1-2/M0 or T3-4a/cN0-2/M0, AJCC2018)
You likely can't join if
- Unresolved grade 2 [(Common Terminology Criteria for Adverse Events (CTCAE 5.0)] or higher toxic reactions caused by previous anticancer treatments
- Known allergic reaction to any ingredients or excipients of the therapy
- Known history of malignancy, unless been cured and no recurrence for 5 years
- Known history of radiation to head and neck
- Active severe clinical infection (\> National Cancer Institute (NCI)-CTCAE version 5.0 grade 2 infection)
- Obvious cardiovascular abnormalities [such as myocardial infarction, superior vena cava syndrome, grade 2 or higher heart disease diagnosed according...
See the full eligibility criteria
- Age: 18-75 years old
- Gender: male and female
- Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-2
- Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)
- Primary tumor with a clinical stage of III/IVA (T1-2/N1-2/M0 or T3-4a/cN0-2/M0, AJCC2018)
- Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- Blood routine: white blood cells (WBCs) \>3,000/mm3, hemoglobin \>8 g/L, platelets \>80,000/mm3
- 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
- Renal function: Serum creatinine \<1.5 times the upper limit of normal
- Coagulation function: INR, PT, APTT\<1.5 times the upper limit of normal
- Signed the informed consent form
- Unresolved grade 2 [(Common Terminology Criteria for Adverse Events (CTCAE 5.0)] or higher toxic reactions caused by previous anticancer treatments
- Known allergic reaction to any ingredients or excipients of the therapy
- Known history of malignancy, unless been cured and no recurrence for 5 years
- Known history of radiation to head and neck
- Active severe clinical infection (\> National Cancer Institute (NCI)-CTCAE version 5.0 grade 2 infection)
- 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...
- Patients receiving immunology-based treatment for any reason
- Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy
- Pregnant or lactating women
- 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...
- 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...
- Participation in other clinical trials within 30 days before enrollment
- Other situations that the investigator considers unsuitable with respect to participating in the trial
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.