NCT05272696RecruitingPhase 2
Pembrolizumab and Induction Chemotherapy in Locally Advanced HNSCC
Induction Therapy With Nab-paclitaxel, Cisplatin and Pembrolizumab in Untreated Locally Advanced Head and Neck Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 1 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To study induction therapy with Nab-paclitaxel, Cisplatin and Pembrolizumab in patients with Locally Advanced HNSCC.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 86 (estimated)
- First submitted
- 28 Feb 2022
- Start date
- 1 Mar 2022
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- Guangdong Provincial People's Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT05272696
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 86
- From 1 Mar 2022 to the primary completion date, 1 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- currently received systemic steroid therapy with dose superior to 10 mg/day of prednisone or equivalent or any other form of immunosuppressive therapy within 14 days prior to the enrollment
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device
- Received a live vaccine within 30 days of planned start of study therapy.
Other illness
- Active, known, or suspected autoimmune disease or Type I diabetes or hypothyroidism requiring hormone replacement therapy and skin diseases requiring systemic treatment.
- Active pulmonary tuberculosis (TB) infection was judged according to chest X-ray examination/CT, sputum examination and clinical physical examination.
- Patients with severe heart disease include congestive heart failure, uncontrollable high-risk arrhythmias, unstable angina pectoris, myocardial infarction, and intractable hypertension.
- Has had another known invasive malignancy or unresectable cancer.
Lab values
- Has known active Hepatitis B (e.g., HBsAg reactive and HBV DNA≥1×10\^4 copies /mL) or Hepatitis C or HIV
- History or current evidence of any condition, therapy, or laboratory abnormality that might influence the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Other
- Pregnant or breastfeeding women.
- The patient (male or female) has the possibility of fertility, but is unwilling or does not take effective contraceptive measures.
Who the study is looking for
- Histologically or cytologically confirmed Head and Neck Squamous Cell Carcinoma (oral cavity, oropharynx, laryngeal and hypopharynx) with locoregionally-advanced disease stage III or IVA without metastasis , previously untreated (AJCC 8th) and had at least one tumour lesion measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Measurable disease based on RECIST 1.1
- ECOG performance status 0-1
- Men and women, Age ≥18 and ≤ 70 years at the time of signing informed consent,
- Adequate hepatic, cardiac and renal function as demonstrated by 1) Hematology: ANC≥1.5×10\^9 /L, HGB≥9 g/dL, PLT≥80×10\^9 /L; 2) Renal: Serum creatinine \< 1.5x ULN or CrCl \> 60mL/min; 3) Hepatic: Total Bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 2.5 x ULN and ALP≤5 x ULN.
- Female subjects of childbearing potential should have a negative pregnancy test result within 28 days prior to enrollment. If the result is more than 7 days before receiving the first dose of study medication, a urine pregnancy test is required for verification.
- Voluntary informed consent, joining the study with good compliance
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.