Trial Title:
Evaluating the Efficacy and Safety of Pembrolizumab Plus Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced (LA) HNSCC
NCT ID:
NCT06102395
Condition:
Head and Neck Squamous Cell Carcinoma
Neoadjuvant Therapy
Pembrolizumab
Conditions: Official terms:
Squamous Cell Carcinoma of Head and Neck
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Carboplatin
Pembrolizumab
Fluorouracil
Nedaplatin
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Pembrolizumab 200mg, IV, on day1 of Q3W, 2 cycle
Arm group label:
Pembrolizumab combined with standard chemotherapy
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Cisplatin 75 mg/m^2, IV, day 1 of Q3W
Arm group label:
Pembrolizumab combined with standard chemotherapy
Arm group label:
Standard chemotherapy
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin AUC (area under curve) 2, IV, day 1-3 of Q3W
Arm group label:
Pembrolizumab combined with standard chemotherapy
Arm group label:
Standard chemotherapy
Intervention type:
Drug
Intervention name:
Nedaplatin
Description:
Nedaplatin 80-100 mg/m^2, IV, day 2-4 of Q3W
Arm group label:
Pembrolizumab combined with standard chemotherapy
Arm group label:
Standard chemotherapy
Intervention type:
Drug
Intervention name:
Nab paclitaxel
Description:
Nab paclitaxel 260 mg/m^2, IV, day 1 of Q3W
Arm group label:
Pembrolizumab combined with standard chemotherapy
Arm group label:
Standard chemotherapy
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Docetaxel 75 mg/m^2, IV, day 1 of Q3W
Arm group label:
Pembrolizumab combined with standard chemotherapy
Arm group label:
Standard chemotherapy
Intervention type:
Drug
Intervention name:
Liposomal paclitaxel
Description:
Liposomal paclitaxel 135-175 mg/m^2, IV, day 1 of Q3W
Arm group label:
Pembrolizumab combined with standard chemotherapy
Arm group label:
Standard chemotherapy
Intervention type:
Drug
Intervention name:
Fluorouracil
Description:
Fluorouracil 750 mg/m^2, IV, day 1-5 of Q3W
Arm group label:
Pembrolizumab combined with standard chemotherapy
Arm group label:
Standard chemotherapy
Summary:
This study is a prospective, open-label, multi-center phase III study; patients with
untreated stage IIIA to stage IVB head and neck squamous cell carcinoma (including oral
cavity cancer, oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer) who
meet the inclusion criteria are randomized 1:1 and given pembrolizumab 200 mg d1+
chemotherapy for 2 cycles (experimental group), 2 cycles of chemotherapy (control group),
and then stratified according to the patient's condition. If the imaging evaluation after
neoadjuvant treatment is (complete response, CR), adjuvant radiotherapy will be given; if
the imaging evaluation is (partial response, PR) or (stable disease, SD), surgery (within
2 weeks) will be performed, followed by standard treatment. The main research hypothesis
of this study: pembrolizumab combined with standard chemotherapy can significantly
improve the rate of pathological complete response (pCR) compared with standard
chemotherapy.
Detailed description:
This study is a prospective, open-label, multi-center phase III study; Patients with
untreated stage IIIA to stage IVB head and neck squamous cell carcinoma (including oral
cavity cancer, oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer) who met
the inclusion criteria were randomized in a 1:1 ratio and given 2 cycles of pembrolizumab
200 mg d1 + chemotherapy (see the table below for detailed chemotherapy regimens)
(experimental group) and 2 cycles of chemotherapy (control group), and were divided
according to the patient's condition. layer. If the imaging evaluation is CR after
neoadjuvant treatment, radiotherapy (60-70Gy) ± chemotherapy (investigator's choice) will
be given as adjuvant treatment; if the imaging evaluation is PR or SD, surgery (within 2
weeks) will be performed, and then standard treatment will be given. treat. If the
imaging evaluation is PD, standard treatment will be given. Enrolled patients must
closely monitor the adverse reactions of chemotherapy and record the time, grade,
treatment measures, outcomes, etc. All patients were reviewed every 3 months for 1 year;
after 1 year, they were reviewed every 6 months for 3 years; patient recurrence and
survival data were recorded.
The investigators speculate that, compared with the traditional induction chemotherapy
regimen, the induction chemotherapy regimen of pembrolizumab combined with chemotherapy
may be safer and more effective, and easier for clinical application. At present, there
are no research reports on the induction chemotherapy of pembrolizumab combined with
cisplatin and nab-paclitaxel for patients with locally advanced operable head and neck
squamous cell carcinoma. We intend to conduct a randomized controlled study on the
efficacy and safety of pembrolizumab combined with chemotherapy as neoadjuvant therapy in
Chinese patients with operable head and neck squamous cell carcinoma, and provide a basis
for the neoadjuvant therapy of pembrolizumab combined with chemotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients with stage IIIA-IVB head and neck squamous cell carcinoma confirmed by
histology and/or cytology;
2. Have not received immunotherapy in the past;
3. The researchers believe that he can safely receive pembrolizumab combined with
chemotherapy or neoadjuvant chemotherapy;
4. Age ≥18 years;
5. ECOG 0-2;
6. Measurable disease as defined by RECIST v1.1;
7. Organs function normally;
8. Female and male participants of reproductive potential must agree to use appropriate
contraception throughout the study period and for 180 days after the last study
treatment;
9. Male participants must not donate sperm throughout the study and for 180 days after
the last study treatment.
Exclusion Criteria:
1. Presence of distant metastasis;
2. Female subjects with a positive urine pregnancy test within 72 hours before the
start of the study or within 24 hours after starting radiation therapy (with or
without cisplatin);
3. received a live vaccine within 30 days before enrollment;
4. Diagnosed with immunodeficiency or receiving systemic steroid treatment or any other
form of immunosuppressive treatment within 7 days before enrollment;
5. Have imaging detectable (even if asymptomatic and/or previously treated) central
nervous system metastases and/or cancerous meningitis;
6. Have undergone surgery before commencing the study or have failed to recover
adequately from toxicity or complications resulting from the intervention;
7. Previous allogeneic tissue/solid organ transplant;
8. Severe hypersensitivity reaction (≥Grade 3) to pembrolizumab or any of its
excipients, radiotherapy, platinum, paclitaxel, 5-FU or their analogs;
9. Have an active autoimmune disease requiring systemic therapy in the past 2 years;
10. History of (non-infectious) pneumonia requiring steroid treatment;
11. Have a history of human immunodeficiency virus (HIV) infection;
12. Have a history of hepatitis B or be positive for hepatitis B virus (defined as a
positive reaction to hepatitis B surface antigen [HBsAg]) or active hepatitis C
(defined as detection of hepatitis C virus [HCV] ribonucleic acid).
13. Have any medical history, treatment, or laboratory abnormalities that could confound
the study results, interfere with participant participation throughout the study, or
be detrimental to the best interests of the participant (e.g., Hashimoto's
thyroiditis, etc.);
14. Have a known history of mental illness or substance abuse disorder
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Tongren Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Yang Zhang
Phone:
+86 13311365369
Email:
zhangyazhangyangent@163.comngent@163.com
Start date:
May 1, 2023
Completion date:
April 30, 2030
Lead sponsor:
Agency:
Beijing Tongren Hospital
Agency class:
Other
Source:
Beijing Tongren Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06102395
