Head and Neck Squamous Cell CarcinomaPhase 3NCT06102395
Evaluating the Efficacy and Safety of Pembrolizumab Plus Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced (LA) HNSCC
A Phase 3 study testing Pembrolizumab, Cisplatin and Carboplatin in people with Head and Neck Squamous Cell Carcinoma and Neoadjuvant Therapy, run by Beijing Tongren Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Neoadjuvant Therapy, Pembrolizumab
- What is being tested?
- Pembrolizumab, Cisplatin and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 30 Apr 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stage IIIA-IVB head and neck squamous cell carcinoma confirmed by histology and/or cytology;
- Have not received immunotherapy in the past;
- The researchers believe that he can safely receive pembrolizumab combined with chemotherapy or neoadjuvant chemotherapy;
- Age ≥18 years;
- ECOG 0-2;
- Measurable disease as defined by RECIST v1.1;
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- Organs function normally;
- 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;
- Male participants must not donate sperm throughout the study and for 180 days after the last study treatment.
Who cannot join
- Presence of distant metastasis;
- 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);
- received a live vaccine within 30 days before enrollment;
- Diagnosed with immunodeficiency or receiving systemic steroid treatment or any other form of immunosuppressive treatment within 7 days before enrollment;
- Have imaging detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or cancerous meningitis;
- Have undergone surgery before commencing the study or have failed to recover adequately from toxicity or complications resulting from the intervention;
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- Previous allogeneic tissue/solid organ transplant;
- Severe hypersensitivity reaction (≥Grade 3) to pembrolizumab or any of its excipients, radiotherapy, platinum, paclitaxel, 5-FU or their analogs;
- Have an active autoimmune disease requiring systemic therapy in the past 2 years;
- History of (non-infectious) pneumonia requiring steroid treatment;
- Have a history of human immunodeficiency virus (HIV) infection;
- 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).
- 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.);
- Have a known history of mental illness or substance abuse disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730
Yang Zhang, +86 13311365369, zhangyazhangyangent@163.comngent@163.com
About this study
Official title: EFFECT-neo: A Prospective, Open-label, Multicenter Phase III Study to Evaluate Efficacy and Safety of Pembrolizumab Combined With Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced (LA) HNSCC
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.
Read the 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.
- Being tested
- Pembrolizumab, Cisplatin, Carboplatin, Nedaplatin, Nab paclitaxel
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Pembrolizumab 200mg, IV, on day1 of Q3W, 2 cycle
CisplatinDrug
Cisplatin 75 mg/m^2, IV, day 1 of Q3W
CarboplatinDrug
Carboplatin AUC (area under curve) 2, IV, day 1-3 of Q3W
NedaplatinDrug
Nedaplatin 80-100 mg/m^2, IV, day 2-4 of Q3W
Nab paclitaxelDrug
Nab paclitaxel 260 mg/m^2, IV, day 1 of Q3W
DocetaxelDrug
Docetaxel 75 mg/m^2, IV, day 1 of Q3W
Liposomal paclitaxelDrug
Liposomal paclitaxel 135-175 mg/m^2, IV, day 1 of Q3W
FluorouracilDrug
Fluorouracil 750 mg/m^2, IV, day 1-5 of Q3W
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab combined with standard chemotherapy | Experimental | Patients receive pembrolizumab 200mg, IV, on day1 of Q3W; plus platinum (cisplatin 75 mg/m^2, IV, day 1 of Q3W or carboplatin AUC (area under curve) 2, IV, day 1-3 of Q3W or nedaplatin 80-100 mg/m^2, IV, day 2-4 of Q3W); plus other chemotherapy（nab-paclitaxel 260 mg/m^2, IV, day 1 of Q3W or docetaxel 75 mg/m^2, IV, day 1 of Q3W or liposomal paclitaxel 135-175 mg/m^2, IV, day 1 of Q3W or fluorouracil 750 mg/m^2, IV, day 1-5 of Q3W）; total 2 cycle Receives: Drug: Pembrolizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Nedaplatin; Drug: Nab paclitaxel; Drug: Docetaxel; Drug: Liposomal paclitaxel; Drug: Fluorouracil |
| Standard chemotherapy | Active comparator | Patients receive platinum (cisplatin 75 mg/m^2, IV, day 1 of Q3W or carboplatin AUC (area under curve) 2, IV, day 1-3 of Q3W or nedaplatin 80-100 mg/m^2, IV, day 2-4 of Q3W); plus other chemotherapy（nab-paclitaxel 260 mg/m^2, IV, day 1 of Q3W or docetaxel 75 mg/m^2, IV, day 1 of Q3W or liposomal paclitaxel 135-175 mg/m^2, IV, day 1 of Q3W or fluorouracil 750 mg/m^2, IV, day 1-5 of Q3W）; total 2 cycle Receives: Drug: Cisplatin; Drug: Carboplatin; Drug: Nedaplatin; Drug: Nab paclitaxel; Drug: Docetaxel; Drug: Liposomal paclitaxel; Drug: Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate (pCR) of pembrolizumab combined with standard chemotherapy neoadjuvant therapy in patients with locally advanced head and neck squamous cell carcinoma
pCR was defined as the absence of residual invasive squamous cell carcinoma within the primary tumor specimen on resection/needle biopsy
Measured: 12 week
Pathological complete response rate (pCR) of standard chemotherapy neoadjuvant chemotherapy in patients with locally advanced head and neck squamous cell carcinoma
pCR was defined as the absence of residual invasive squamous cell carcinoma within the primary tumor specimen on resection/needle biopsy
Measured: 12 week
Secondary outcomes (18)
The objective response rate (ORR) of neoadjuvant therapy with pembrolizumab combined with standard chemotherapy
ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1
Measured: 12 week
The objective response rate (ORR) of neoadjuvant chemotherapy with standard chemotherapy
ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1
Measured: 6 week
The 1-year and 2-year event-free survival rates (1y-EFS, 2y-EFS) after pembrolizumab combined with standard chemotherapy neoadjuvant therapy
EFS is defined as the time from randomization to any event, including disease progression, discontinuation of treatment for any reason, or death
Measured: 2 year
The 1-year and 2-year event-free survival rate (1y-EFS, 2y-EFS) after neoadjuvant chemotherapy with standard chemotherapy
EFS is defined as the time from randomization to any event, including disease progression, discontinuation of treatment for any reason, or death
Measured: 2 year
The functional preservation rate of pembrolizumab combined with standard chemotherapy
Functional preservation is defined as preserving and repairing the anatomical structure of the larynx, and reconstructing the breathing and pronunciation functions of the larynx, or protecting the appearance of the tongue and physiological functions such as speech, chewing and swallowing
Measured: 3 year
The functional preservation rate of standard chemotherapy
Functional preservation is defined as preserving and repairing the anatomical structure of the larynx, and reconstructing the breathing and pronunciation functions of the larynx, or protecting the appearance of the tongue and physiological functions such as speech, chewing and swallowing
Measured: 3 year
The 2-year overall survival rate (2y-OS) after Neoadjuvant pembrolizumab combined with standard chemotherapy
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
Measured: 2 year
The 2-year overall survival rate (2y-OS) after Neoadjuvant Therapy with standard chemotherapy
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
Measured: 2 year
Pathological complete response rate (pCR) of pembrolizumab combined with standard chemotherapy as neoadjuvant therapy in patients of locally advanced head and neck squamous cell carcinoma with CPS (combined positive score) ≥1
pCR was defined as the absence of residual invasive squamous cell carcinoma in the resected primary lesion specimen
Measured: 12 week
Pathological complete response rate (pCR) of pembrolizumab combined with standard chemotherapy as neoadjuvant therapy in patients of locally advanced head and neck squamous cell carcinoma with CPS (combined positive score) <1
pCR was defined as the absence of residual invasive squamous cell carcinoma in the resected primary lesion specimen
Measured: 12 week
The 2-year event-free survival rates (2y-EFS) after pembrolizumab combined with standard chemotherapy neoadjuvant therapy with CPS (combined positive score) ≥1
EFS is defined as the time from randomization to any event, including disease
Measured: 2 year
The 2-year event-free survival rates (2y-EFS) after pembrolizumab combined with standard chemotherapy neoadjuvant therapy with CPS (combined positive score) <1
EFS is defined as the time from randomization to any event, including disease
Measured: 2 year
The 2-year overall survival rate (2y-OS) after Neoadjuvant pembrolizumab combined with standard chemotherapy with CPS(combined positive score) ≥1
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
Measured: 2 year
The 2-year overall survival rate (2y-OS) after Neoadjuvant pembrolizumab combined with standard chemotherapy with CPS(combined positive score) <1
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
Measured: 2 year
Incidence of Treatment-Emergent Adverse Events (TRAEs) of pembrolizumab combined with standard chemotherapy in neoadjuvant therapy
TRAEs include 5 levels, base on Common Terminology Criteria for Adverse Events (CTCAE) is widely accepted as the standard classification and severity grading scale for adverse events in cancer therapy, clinical trials and other oncology settings.
Measured: 3 year
Incidence of Treatment-Emergent Adverse Events (TRAEs) of neoadjuvant chemotherapy with standard chemotherapy
TRAEs include 5 levels, base on Common Terminology Criteria for Adverse Events (CTCAE) is widely accepted as the standard classification and severity grading scale for adverse events in cancer therapy, clinical trials and other oncology settings.
Measured: 3 year
The quality of life of pembrolizumab combined with standard chemotherapy neoadjuvant therapy measured by KPS (Karnofsky performance status) scores
A standard way of measuring the ability of cancer patients to perform ordinary tasks. The KPS scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities.
Measured: 3 year
The quality of life of standard chemotherapy neoadjuvant therapy measured by KPS (Karnofsky performance status) scores
A standard way of measuring the ability of cancer patients to perform ordinary tasks. The KPS scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 May 2023
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhigang Huang, Study chair, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102395
- Sponsor's protocol ID
- NCT23456
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT-neo: A Prospective, Open-label, Multicenter Phase III Study to Evaluate Efficacy and Safety of Pembrolizumab Combined With Standard Chemotherapy in the Neoadjuvant Treatment of Local Advanced (LA) HNSCC
- ClinicalTrials.gov ID
- NCT06102395
- Acronym / sponsor ID
- NCT23456
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab combined with standard chemotherapy | Experimental | Drug: Pembrolizumab, Drug: Cisplatin, Drug: Carboplatin, Drug: Nedaplatin, Drug: Nab paclitaxel, Drug: Docetaxel, Drug: Liposomal paclitaxel, Drug: FluorouracilPatients receive pembrolizumab 200mg, IV, on day1 of Q3W; plus platinum (cisplatin 75 mg/m^2, IV, day 1 of Q3W or carboplatin AUC (area under curve) 2, IV, day 1-3 of Q3W or nedaplatin 80-100 mg/m^2, IV, day 2-4 of Q3W); plus other chemotherapy（nab-paclitaxel 260 mg/m^2, IV, day 1 of Q3W or docetaxel 75 mg/m^2, IV, day 1 of Q3W or liposomal paclitaxel 135-175 mg/m^2, IV, day 1 of Q3W or fluorouracil 750 mg/m^2, IV, day 1-5 of Q3W）; total 2 cycle |
| Standard chemotherapy | Active comparator | Drug: Cisplatin, Drug: Carboplatin, Drug: Nedaplatin, Drug: Nab paclitaxel, Drug: Docetaxel, Drug: Liposomal paclitaxel, Drug: FluorouracilPatients receive platinum (cisplatin 75 mg/m^2, IV, day 1 of Q3W or carboplatin AUC (area under curve) 2, IV, day 1-3 of Q3W or nedaplatin 80-100 mg/m^2, IV, day 2-4 of Q3W); plus other chemotherapy（nab-paclitaxel 260 mg/m^2, IV, day 1 of Q3W or docetaxel 75 mg/m^2, IV, day 1 of Q3W or liposomal paclitaxel 135-175 mg/m^2, IV, day 1 of Q3W or fluorouracil 750 mg/m^2, IV, day 1-5 of Q3W）; total 2 cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with stage IIIA-IVB head and neck squamous cell carcinoma confirmed by histology and/or cytology;
- Have not received immunotherapy in the past;
- The researchers believe that he can safely receive pembrolizumab combined with chemotherapy or neoadjuvant chemotherapy;
- Age ≥18 years;
- ECOG 0-2;
Key exclusion criteria (14 listed)
- Presence of distant metastasis;
- 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);
- received a live vaccine within 30 days before enrollment;
- Diagnosed with immunodeficiency or receiving systemic steroid treatment or any other form of immunosuppressive treatment within 7 days before enrollment;
- Have imaging detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or cancerous meningitis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabPembrolizumab 200mg, IV, on day1 of Q3W, 2 cycle | Drug | Pembrolizumab combined with standard chemotherapy |
| CisplatinCisplatin 75 mg/m^2, IV, day 1 of Q3W | Drug | Pembrolizumab combined with standard chemotherapy, Standard chemotherapy |
| CarboplatinCarboplatin AUC (area under curve) 2, IV, day 1-3 of Q3W | Drug | Pembrolizumab combined with standard chemotherapy, Standard chemotherapy |
| NedaplatinNedaplatin 80-100 mg/m^2, IV, day 2-4 of Q3W | Drug | Pembrolizumab combined with standard chemotherapy, Standard chemotherapy |
| Nab paclitaxelNab paclitaxel 260 mg/m^2, IV, day 1 of Q3W | Drug | Pembrolizumab combined with standard chemotherapy, Standard chemotherapy |
| DocetaxelDocetaxel 75 mg/m^2, IV, day 1 of Q3W | Drug | Pembrolizumab combined with standard chemotherapy, Standard chemotherapy |
| Liposomal paclitaxelLiposomal paclitaxel 135-175 mg/m^2, IV, day 1 of Q3W | Drug | Pembrolizumab combined with standard chemotherapy, Standard chemotherapy |
| FluorouracilFluorouracil 750 mg/m^2, IV, day 1-5 of Q3W | Drug | Pembrolizumab combined with standard chemotherapy, Standard chemotherapy |
Primary outcome
Pathological complete response rate (pCR) of pembrolizumab combined with standard chemotherapy neoadjuvant therapy in patients with locally advanced head and neck squamous cell carcinoma
Time frame: 12 week
pCR was defined as the absence of residual invasive squamous cell carcinoma within the primary tumor specimen on resection/needle biopsy
Pathological complete response rate (pCR) of standard chemotherapy neoadjuvant chemotherapy in patients with locally advanced head and neck squamous cell carcinoma
Time frame: 12 week
pCR was defined as the absence of residual invasive squamous cell carcinoma within the primary tumor specimen on resection/needle biopsy
18 secondary outcomes
The objective response rate (ORR) of neoadjuvant therapy with pembrolizumab combined with standard chemotherapy
Time frame: 12 week
The objective response rate (ORR) of neoadjuvant chemotherapy with standard chemotherapy
Time frame: 6 week
The 1-year and 2-year event-free survival rates (1y-EFS, 2y-EFS) after pembrolizumab combined with standard chemotherapy neoadjuvant therapy
Time frame: 2 year
The 1-year and 2-year event-free survival rate (1y-EFS, 2y-EFS) after neoadjuvant chemotherapy with standard chemotherapy
Time frame: 2 year
The functional preservation rate of pembrolizumab combined with standard chemotherapy
Time frame: 3 year
The functional preservation rate of standard chemotherapy
Time frame: 3 year
The 2-year overall survival rate (2y-OS) after Neoadjuvant pembrolizumab combined with standard chemotherapy
Time frame: 2 year
The 2-year overall survival rate (2y-OS) after Neoadjuvant Therapy with standard chemotherapy
Time frame: 2 year
Pathological complete response rate (pCR) of pembrolizumab combined with standard chemotherapy as neoadjuvant therapy in patients of locally advanced head and neck squamous cell carcinoma with CPS (combined positive score) ≥1
Time frame: 12 week
Pathological complete response rate (pCR) of pembrolizumab combined with standard chemotherapy as neoadjuvant therapy in patients of locally advanced head and neck squamous cell carcinoma with CPS (combined positive score) <1
Time frame: 12 week
The 2-year event-free survival rates (2y-EFS) after pembrolizumab combined with standard chemotherapy neoadjuvant therapy with CPS (combined positive score) ≥1
Time frame: 2 year
The 2-year event-free survival rates (2y-EFS) after pembrolizumab combined with standard chemotherapy neoadjuvant therapy with CPS (combined positive score) <1
Time frame: 2 year
The 2-year overall survival rate (2y-OS) after Neoadjuvant pembrolizumab combined with standard chemotherapy with CPS(combined positive score) ≥1
Time frame: 2 year
The 2-year overall survival rate (2y-OS) after Neoadjuvant pembrolizumab combined with standard chemotherapy with CPS(combined positive score) <1
Time frame: 2 year
Incidence of Treatment-Emergent Adverse Events (TRAEs) of pembrolizumab combined with standard chemotherapy in neoadjuvant therapy
Time frame: 3 year
Incidence of Treatment-Emergent Adverse Events (TRAEs) of neoadjuvant chemotherapy with standard chemotherapy
Time frame: 3 year
The quality of life of pembrolizumab combined with standard chemotherapy neoadjuvant therapy measured by KPS (Karnofsky performance status) scores
Time frame: 3 year
The quality of life of standard chemotherapy neoadjuvant therapy measured by KPS (Karnofsky performance status) scores
Time frame: 3 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhigang Huang study chair
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pembrolizumab, Cisplatin and Carboplatin in people with Head and Neck Squamous Cell Carcinoma and Neoadjuvant Therapy, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhigang Huang (+86 13701208337, huangzhigang1963@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (pCR) of pembrolizumab combined with standard chemotherapy neoadjuvant therapy in patients with locally advanced head and neck squamous cell carcinoma (time frame: 12 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.