Pembrolizumab and Induction Chemotherapy in Locally Advanced HNSCC

NCT05272696 | Recruiting Phase 2

• 1 other identifier: INDUCTION THERAPY
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

To study induction therapy with Nab-paclitaxel, Cisplatin and Pembrolizumab in patients with Locally Advanced HNSCC.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• Objective response rate

  Objective response rate (ORR) will be determinated by evaluation of Complete Response (CR) and Partial Response (PR)

  24 months

• Evaluation of Safety

  Toxicity will be evaluated according to NCI-CTCAE v4.03

  24 months

• Rate of organ preservation

  After two courses of induction treatment, MDT discussed whether to accept surgical treatment or concurrent chemoradiotherapy, and the proportion of patients whose organ function can be preserved after treatment.

  24 months

Secondary Outcomes (2)

• overall survival (OS)

  24 months

• progression-free survival (PFS)

  24 months

Study Arms (1)

Experimental

EXPERIMENTAL

All enrolled patients will receive two cycles of chemotherapy consisting of nab-paclitaxel (260 mg/m² on days 1), cisplatin (75 mg/m² on days 1), and Pembrolizumab (200 mg on days 1). Each cycle is repeated every 21 days. After induction therapy, patients with PR but the maximum diameter of tumor \> 3cm or SD or PD can receive surgery directly. After surgery, adjuvant CRT will be given for patients with high-risk factors. After induction therapy, patients with PR and maximum tumor diameter ≤ 3cm or CR evaluated by MDT after 2 courses induction therapy can receive CRT. Evaluation was performed 3 months after CRT. After MDT discussion, patients with high-risk factors need maintenance treatment.

Drug: Nab-paclitaxel, cisplatin and Pembrolizumab combination; Procedure: surgery; Radiation: Adjuvant Chemoradiotherapy; Drug: Radical concurrent chemoradiotherapy

Interventions

Nab-paclitaxel, cisplatin and Pembrolizumab combination DRUG

Pembrolizumab in combination with Nab-paclitaxel and cisplatin as induction therapy

Experimental

surgery PROCEDURE

Patients with PR but the maximum diameter of tumor \> 3cm or SD or PD can receive surgery directly.

Experimental

Adjuvant Chemoradiotherapy RADIATION

After surgery, adjuvant Chemoradiotherapy or radiotherapy will be given for patients with high-risk factors.

Experimental

Radical concurrent chemoradiotherapy DRUG

Patients with PR and maximum tumor diameter ≤ 3cm or CR evaluated by MDT after 2 courses induction therapy can receive Radical concurrent chemoradiotherapy. Evaluation was performed 3 months after CRT. After MDT discussion, patients with high-risk factors need maintenance treatment.

Experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active, known, or suspected autoimmune disease or Type I diabetes or hypothyroidism requiring hormone replacement therapy and skin diseases requiring systemic 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
• Has known active Hepatitis B (e.g., HBsAg reactive and HBV DNA≥1×10\^4 copies /mL) or Hepatitis C or HIV
• 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.
• Pregnant or breastfeeding women.
• The patient (male or female) has the possibility of fertility, but is unwilling or does not take effective contraceptive measures.
• 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
• Has had another known invasive malignancy or unresectable cancer.
• Received a live vaccine within 30 days of planned start of study therapy.
• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

130-nm albumin-bound paclitaxel; Cisplatin; Surgical Procedures, Operative; Chemoradiotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Chemoradiotherapy; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Central Study Contacts

Haiqing Ma

CONTACT

+86 18575604025; mahaiqing@gdph.org.cn

Siyi Zhang

CONTACT

+86 13570339871; szhang555@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: March 1, 2022
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)