Actively Recruiting
Neoadjuvant Toripalimab and Albumin Paclitaxel/Cisplatin Versus Docetaxel/Cisplatin/5-fluorouracil (TPF) on Pathological Response in Locally Advanced Resectable Oral Squamous Cell Carcinoma
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2023-11-22
80
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pathological effectiveness and safety of a new combination treatment called neoadjuvant Toripalimab with Albumin paclitaxel and Cisplatin (TTP) compared to the standard chemotherapy regimen Docetaxel, Cisplatin, and 5-fluorouracil (TPF) in patients with locally advanced, resectable oral squamous cell carcinoma (OSCC). This study aims to find a better pre-surgery treatment approach to improve outcomes for these patients, building on earlier promising results from a smaller trial. Participants will be randomly assigned to one of two groups. The first group receives two cycles of intravenous Albumin paclitaxel, Cisplatin, and Toripalimab on days 1 and 22. The second group receives two cycles of intravenous Docetaxel and Cisplatin on days 1 and 22, plus 5-fluorouracil as a continuous infusion for five days during each cycle. After these treatments, all participants undergo surgery and may receive additional therapy as needed. During the study, participants will be closely monitored for their major pathological response three months after treatment begins. Researchers will also track disease-free survival and overall survival over two years. Assessments include physical exams, lab tests, and imaging to evaluate tumor response and safety. The total study duration extends up to about five years, including follow-up for long-term outcomes.
CONDITIONS
Brief Title
Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Male or female gender
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Histopathological diagnosis of oral squamous cell carcinoma affecting tongue, gums, cheek, floor of mouth, hard palate, or posterior molar region
- Clinical stage III or IVA primary tumor as defined by AJCC2018
- At least one measurable tumor lesion according to RECIST v1.1
- Adequate blood counts: white blood cells over 3,000/mm3, hemoglobin over 8 g/L, platelets over 80,000/mm3
- Liver function with ALT/AST less than 2.5 times upper normal limit and bilirubin less than 1.5 times upper normal limit
- Renal function with serum creatinine less than 1.5 times upper normal limit
- Coagulation parameters (INR, PT, APTT) less than 1.5 times upper normal limit
- Signed informed consent form
You will not qualify if you...
- Unresolved grade 2 or higher toxic reactions from previous anticancer treatments
- Known allergic reactions to treatment ingredients
- History of other malignancies unless cured with no recurrence for 5 years
- Previous radiation therapy to head and neck
- Active severe infections above grade 2
- Significant cardiovascular diseases such as recent myocardial infarction or severe heart failure
- Current immunology-based treatments
- History of active bleeding, blood clotting disorders, or anticoagulant therapy
- Pregnant or breastfeeding women
- Uncontrolled high blood pressure or significant cardiovascular events within 6 months
- Severe uncontrolled infections, HIV/AIDS, autoimmune diseases, or history of organ or stem cell transplantation
- Participation in other clinical trials within 30 days
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks
Participants receive two cycles of neoadjuvant therapy with either Toripalimab, Albumin paclitaxel, and Cisplatin (TTP) or Docetaxel, Cisplatin, and 5-Fluorouracil (TPF) before surgery.
2 treatment visits spaced 21 days apart
Duration - Variable depending on surgery and postoperative care
Participants undergo surgery and postoperative adjuvant therapy following neoadjuvant treatment.
Surgery visit plus postoperative visits as needed
Duration - Up to 24 months
Participants are monitored for disease-free survival and overall survival for up to 2 years after treatment.
Regular follow-up visits during the 2-year period
Trial Site Locations
Total: 1 location
1
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 20011
Actively Recruiting
Research Team
L
Lai-ping Zhong, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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