Actively Recruiting
Safety and Efficacy of Four Courses of Pembrolizumab Combined With Carboplatin and Albumin-binding Paclitaxel Versus Two Courses of Neoadjuvant Therapy in Patients With Resectable Head and Neck Squamous Cell Carcinoma (T3 or T4, N0)
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2023-09-07
192
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of different courses of pembrolizumab combined with carboplatin and albumin-binding paclitaxel as preoperative (neoadjuvant) therapy in patients with resectable head and neck squamous cell carcinoma (stages T3 or T4, N0). This phase II, prospective, randomized study aims to compare four treatment cycles versus two cycles and assess outcomes such as pathological complete response, adverse events, survival rates, and radiological responses. The study also explores various factors that could influence treatment response and prognosis. Participants are randomly assigned to receive either four cycles or two cycles of pembrolizumab (200 mg IV), carboplatin (300 mg/m2 IV), and albumin-bound paclitaxel (260 mg/m2 IV) every 21 days, followed by surgery. Each treatment cycle occurs on day 1, and continuation depends on absence of disease progression or unacceptable toxicity. The study collects clinical, pathological, imaging, and serological data before and after treatment to evaluate the therapies. During the study, participants undergo assessments including imaging, pathology examination of tumor tissues, and laboratory tests. Researchers monitor adverse events for 90 days post-surgery and measure pathological response six weeks after treatment initiation. Longer-term outcomes such as event-free and overall survival are tracked for up to five years. Data on operation delays and radiographic responses are also gathered to assess treatment safety and efficacy throughout the study duration.
CONDITIONS
Brief Title
4 Courses vs 2 Courses of Pembrolizumab Combined With Carboplatin and Albumin-binding Paclitaxel of Neoadjuvant Therapy in HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Diagnosed with surgically resectable head and neck squamous cell carcinoma, stage T3 or T4, N0
- At least one measurable lesion based on RECIST 1.1 criteria
- No prior systemic antitumor therapy for advanced or metastatic disease, or completed such therapy at least 6 months ago
- ECOG performance status of 0 or 1
- Expected survival time greater than 3 months
- Adequate organ function as shown by recent laboratory tests meeting specified thresholds
- Negative pregnancy test for women of childbearing potential before starting treatment
- Use of effective contraception during treatment and up to 120 days after last study drug administration
You will not qualify if you...
- Other malignant diseases within 5 years prior to treatment (with some exceptions like treated basal cell carcinoma)
- Participation in other clinical trials or use of investigational drugs within 4 weeks before starting treatment
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or similar immune checkpoint inhibitors
- Recent use of systemic immunomodulatory drugs for head and neck squamous cell carcinoma within 2 weeks
- Active autoimmune diseases requiring systemic treatment within 2 years
- Recent systemic glucocorticoid or immunosuppressive therapy within 7 days before treatment
- Uncontrolled pleural or abdominal effusions
- History of organ or stem cell transplantation (except corneal)
- Allergies to study drug components
- Incomplete recovery from previous treatment toxicities
- Known HIV infection
- Untreated active hepatitis B or active hepatitis C infection
- Receipt of live vaccines within 30 days before treatment
- Pregnant or breastfeeding women
- Serious uncontrolled diseases such as severe heart conditions, recent arterial thrombosis, uncontrolled blood pressure, active lung disease, infections, liver disease, poor diabetes control, significant proteinuria, or mental disorders
- Any condition that may interfere with study participation or results as judged by the investigator
AI-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 - Up to 12 weeks (2 or 4 cycles of 21 days each)
Participants receive either 2 or 4 courses of pembrolizumab, carboplatin, and albumin-bound paclitaxel given intravenously on Day 1 of each 21-day cycle. Treatment continues for up to 2 or 4 cycles depending on the assigned group, unless disease progression or unacceptable toxicity occurs.
1 visit every 3 weeks for up to 4 visits
Duration - 1 to 2 weeks
Participants undergo surgery to remove the tumor after completing neoadjuvant therapy.
1 surgical visit (in-person)
Duration - 90 days after surgery
Participants are monitored for safety and efficacy outcomes including adverse events and pathologic response following surgery.
Approximately 3 follow-up visits post-surgery
Trial Site Locations
Total: 1 location
1
Sun yat-sen memorial hospital
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
J
Jinsong Li, MD
H
Haotian Cao, MD
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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