Head and Neck Squamous Cell CarcinomaPhase 2NCT04857164
Study of Pembrolizumab Combined with Chemotherapy in the First Line Therapy for R/M HNSCC in China
A Phase 2 study testing Pembrolizumab combined with Chemotherapy in people with Head and Neck Squamous Cell Carcinoma, run by Yuankai Shi at 1 site in China.
Trial summary
This trial is main evaluate the efficacy and safety of pembrolizumab combined with chemotherapy in the first-line treatment of Chinese patients with recurrent or metastatic head and neck squamous cell carcinoma 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
- What is being tested?
- Pembrolizumab combined with Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2021to 1 Jan 2026
- Phase
- Phase 2
- 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
- Voluntarily sign written informed consent before screening;
- Age 18~75 years old;
- ECOG physical status score 0-1 points;
- Head squamous cell carcinoma (HNSCC) diagnosed by histology or cytology, the primary site is oral cavity, oral cavity Throat, lower throat or throat;
- Recurrent and/or metastatic HNSCC without indications for local radical treatment;
- According to the evaluation criteria for the efficacy of solid tumors (RECIST version 1.1), there is at least one measurable lesion, right For lesions that have received radiotherapy in the past, only if there is clear disease progression 3 months after the end of radiotherapy, can it be Was selected as the target lesion;
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- There are a large number of tumor tissue samples for PD-L1 immunohistochemical detection;
- The expected survival period exceeds 3 months;
- The main organs function normally, that is, they meet the following standards:
- Blood routine (not receiving blood transfusion 14 months before screening examination, erythropoietin (EPO), granulocyte set Fall stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF) treatment): neutral Granulocyte ≥1.5×l09
- L, platelets ≥100×109
- L, hemoglobin≥90g/L; ii. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ALT and AST ≤ 3 for those without liver metastasis ×ULN, ALT and AST for liver metastases≤5×ULN; total bilirubin (TBIL)≤1.5×ULN (Gilbert Syndrome patients, ≤3×ULN); iii. Renal function: Serum creatinine (Cr)≤1.5×ULN or tendon clearance (Ccr)≥50ml/min (connect Residues treated with carboplatin) or ≥60ml/min (residuals treated with cisplatin); iv. Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), thrombin Original time (PT)≤1.5×ULN; v. Heart echocardiogram: left ventricular ejection fraction (LVEF) ≥50%;
- Women should agree to use contraceptive measures (such as intrauterine birth control) during the study period and within 6 months after the study ends.
- Device [IUD], contraceptive pill or condom); 7 diabetes blood pregnancy test was negative before study enrollment, and it must be non-Breastfeeding patients; males should agree to use contraceptive measures during the study period and within 6 months after the end of the study period patient.
Who cannot join
- Patients who are suitable for local treatment and are willing to local treatment;
- Have received systemic chemotherapy, but does not include treatment for locally advanced disease as a part of multimodal treatment Chemotherapy (the end of this treatment must be more than 6 months after the first trial medication); Note: Multimodal therapy includes induction chemotherapy, concurrent radiotherapy and chemotherapy and adjuvant chemotherapy.
- Locally advanced head and neck squamous cell carcinoma multimodal treatment is completed within 6 months of disease progression;
- Have received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or targeting effects in the past Any other antibody or drug immunotherapy in T cell co-stimulation or immune checkpoint pathway;
- Other malignant tumors have occurred within 5 years or at the same time during the current period, except for cured cervical carcinoma in situ, non- Skin cancer of melanoma or other tumors/cancers that have undergone radical treatment and have no signs of disease for at least 5 years;
- Received cetuximab treatment within 6 months before the first administration;
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- According to the standard of common adverse event term (NCI CTCAEv5.0), peripheral neuropathy has been ≥2 grade;
- With known active central nervous system metastasis (CNS) and/or cancerous meningitis: previous treatment Subjects with brain metastases treated for treatment can participate in the study, provided that they are clinically stable for at least 2 weeks and there are no new or enlarged brains.
- Evidence was transferred, and steroids were discontinued 14 days before study drug administration. The stable brain metastasis in this definition should be in Determine before the first administration of the study drug. Subjects with asymptomatic brain metastases (ie no neurological symptoms, no need Corticosteroids, and no lesions> 1.5cm) can participate, but the brain needs to be regularly performed as a disease site Film degree exam;
- Did not recover from any acute effects of previous surgery, chemotherapy or radiotherapy, that is, did not fall to ≤1 grade (NCI CTCAEv5.0) subjects (except for hair loss). If the nutritional status is stable, allow previous radiotherapy and/or surgery Chronic late toxicity (pharyngeal/larynx toxicity, ie dry mouth, abnormal speech, swallowing, etc.);
- Any component of the studied drug or preparation has caused severe allergic reactions, including known Severe allergic reaction to Longan antibody (NCI CTCAEv5.0≥3);
- Have received anti-tumor drug treatment (such as chemotherapy, hormone therapy, immune Disease treatment, antibody treatment, radiotherapy, etc.), except for palliative radiotherapy for bones to relieve pain;
- Chinese herbal medicine or Chinese patent medicine receiving anti-tumor treatment ≤1 week before the first administration;
- Have received major surgery within 4 weeks before the first administration or are expected to undergo major surgery during the study period;
- Immunosuppressive drugs need to be used 2 weeks before the first administration or within 2 weeks or during the study period. The following conditions are excluded:
- Intranasal, inhaled, topical steroid or topical steroid injection (such as intra-articular injection);
- Physiological dose of systemic corticosteroids (≤10mg/day prednisone or equivalent dose);
- Short-term (≤7 days) use of steroids to prevent or treat non-autoimmune allergic diseases;
- Subjects who are known to have active or have a history of autoimmune diseases that are likely to relapse (such as:
- Systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple Sexual sclerosis, vasculitis, glomerulitis, etc.), or high risk (such as receiving an organ transplant and requiring immunotherapy) Of patients. However, the following patients are allowed to join the group: patients with type I diabetes who are in stable condition after using a fixed dose of insulin Those; autoimmune hypothyroidism requiring only hormone replacement therapy; no need for systemic therapy Skin diseases (such as eczema, skin rashes that account for less than 10% of the body surface, psoriasis without ophthalmological symptoms, etc.);
- Subjects with known history of interstitial lung disease, history of non-infectious pneumonia, or high suspicion of interstitial lung disease Those who have previously had drug-induced or radiation non-infectious pneumonia but asymptomatic subjects are allowed to enter the group;
- A history of human immunodeficiency virus infection (positive HIV test), or other acquired or congenital Immunodeficiency disease, or history of organ transplantation, or history of stem cell transplantation;
- The hepatitis B or C virological examination at the time of screening meets any of the following:
- HBsAg positive, and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) titer ≥104 Copy number/ml or ≥2000 IU/ml;
- HCV antibody is positive, and HCV-RNA is higher than the detection limit of the analysis method;
- Within 2 weeks or 2 weeks before the first administration, the subject has an active infection that requires systemic treatment or is uncontrollable Infection (except for simple urinary tract infection or upper respiratory tract infection);
- Live virus vaccine was vaccinated within 4 weeks before the first dose. Allows vaccination against seasonal influenza that does not contain live viruses seedling;
- Serous effusions (such as pleural effusions and pleural effusions) with clinical symptoms that require clinical intervention or stable time less than 4 weeks ascites);
- Known to be accompanied by serious medical diseases, such as heart function abnormalities of grade III and above (New York Heart Association [NYHA]), cardiovascular diseases such as ischemic heart disease (such as myocardial infarction or angina pectoris), or before the first administration 3 A history of myocardial infarction within months, and poorly controlled diabetes (fasting blood glucose ≥ 10mmol/L) or poorly controlled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg);
- Medical or psychiatric history or laboratory abnormal history that may interfere with the interpretation of results;
- The subject is currently enrolled in other research equipment or research drug research, or is away from other research drugs Or the study device is out of use for less than or equal to 4 weeks;
- The subject is known to be addicted to alcohol or drugs;
- The researcher believes that the subjects have other conditions that may affect their compliance with the protocol and the evaluation of research indicators.
- Circumstances, subjects who are not suitable to participate in the study.
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
National Cancer Center/Cancer Hospitial,Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Yuankai Shi, MD, +86-10-87788293, syuankaipumc@126.com
About this study
Official title: A Prospective Study of Pembrolizumab Combined with Chemotherapy (cisplatin or Carboplatin + Albumin-bound Paclitaxel) in First-line Therapy for Patients with Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck
This trial is main evaluate the efficacy and safety of pembrolizumab combined with chemotherapy in the first-line treatment of Chinese patients with recurrent or metastatic head and neck squamous cell carcinoma
Read the detailed description
This trial is a single-center, prospective phase II clinical study, which mainly evaluates the efficacy and safety of first-line treatment with pembrolizumab combined with chemotherapy in patients with recurrent and/or metastatic head and neck squamous cell carcinoma
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Pembrolizumab combined with Chemotherapy
- Keywords
- Head and Neck Cancer, immune therapy, Pembrolizumab combined with chemotherapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pembrolizumab combined with ChemotherapyDrug
Also called keytruda and Chemotherapy
Pembrolizumab (formerly lambrolizumab, brand name Keytruda) is a humanized antibody used in cancer Chemotherapy regimen is selected by the investigator immunotherapy. This includes to treat melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, and stomach cancer.
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab combined with Chemotherapy | Experimental | Chemotherapy regimen* is as follows, selected by the investigator, 3 weeks (21 days) is a cycle，combined with pembrolizumab 200 mg intravenously on day 1, every 21 days is a treatment cycle until the disease progresses or the toxicity cannot be tolerated(Less than or equal to 35 cycle)
*1) Cisplatin(75 mg/m2) + albumin-bound paclitaxel(260 mg/m2) 2)Cisplatin(25 mg/m2,d1-d3) + albumin-bound paclitaxel(260 mg/m2) 3)Carboplatin(AUC5) + Albumin-bound Paclitaxel(260 mg/m2) Receives: Drug: Pembrolizumab combined with Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate(ORR)
To evaluate the objective response rate of pembrolizumab combined with chemotherapy in the first-line treatment of Chinese patients with recurrent and or metastatic head and neck squamous cell carcinoma
Measured: 18 weeks
Secondary outcomes (5)
progression free survival(PFS)
To evaluate the progression free survival (PFS) of pembrolizumab combined with chemotherapy in the first-line treatment of Chinese patients with recurrent and or metastatic head and neck squamous cell carcinoma
Measured: 4 year
disease control rate (DCR)
To evaluate the disease control rate of pembrolizumab combined with chemotherapy in the first-line treatment of Chinese patients with recurrent and or metastatic head and neck squamous cell carcinoma
Measured: 4 year
duration of response (DOR)
To evaluate the duration of response (DOR) of pembrolizumab combined with chemotherapy in the first-line treatment of Chinese patients with recurrent and or metastatic head and neck squamous cell carcinoma
Measured: 4 year
progression free survival rate(PFS rate)
PFS rates at 6 and 12 months
Measured: 6 months and 12 months
overall survival (OS)
To evaluate the survival time (OS) of pembrolizumab combined with chemotherapy in the first-line treatment of Chinese patients with recurrent and or metastatic head and neck squamous cell carcinoma
Measured: 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start30 Apr 2021
- Primary completion20 Aug 2023
- Study completion1 Jan 2026 (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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuankai Shi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuankai Shi, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Yuankai Shi, MD, Principal investigator, Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857164
- Sponsor's protocol ID
- KTP-001
- Status last verified
- Jan 2025
- First submitted
- 14 Apr 2021
- Last updated
- 28 Jan 2025
- 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 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Pembrolizumab Combined with Chemotherapy (cisplatin or Carboplatin + Albumin-bound Paclitaxel) in First-line Therapy for Patients with Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT04857164
- Acronym / sponsor ID
- KTP-001
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Head and Neck Cancer, immune therapy, Pembrolizumab combined with chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Yuankai ShiUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 23 Apr 2021 (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 trial is main evaluate the efficacy and safety of pembrolizumab combined with chemotherapy in the first-line treatment of Chinese patients with recurrent or metastatic head and neck squamous cell carcinoma
Detailed description
This trial is a single-center, prospective phase II clinical study, which mainly evaluates the efficacy and safety of first-line treatment with pembrolizumab combined with chemotherapy in patients with recurrent and/or metastatic head and neck squamous cell carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab combined with Chemotherapy | Experimental | Drug: Pembrolizumab combined with ChemotherapyChemotherapy regimen* is as follows, selected by the investigator, 3 weeks (21 days) is a cycle，combined with pembrolizumab 200 mg intravenously on day 1, every 21 days is a treatment cycle until the disease progresses or the toxicity cannot be tolerated(Less than or equal to 35 cycle) *1) Cisplatin(75 mg/m2) + albumin-bound paclitaxel(260 mg/m2) 2)Cisplatin(25 mg/m2,d1-d3) + albumin-bound paclitaxel(260 mg/m2) 3)Carboplatin(AUC5) + Albumin-bound Paclitaxel(260 mg/m2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Voluntarily sign written informed consent before screening;
- Age 18~75 years old;
- ECOG physical status score 0-1 points;
- Head squamous cell carcinoma (HNSCC) diagnosed by histology or cytology, the primary site is oral cavity, oral cavity Throat, lower throat or throat;
- Recurrent and/or metastatic HNSCC without indications for local radical treatment;
Key exclusion criteria (34 listed)
- Patients who are suitable for local treatment and are willing to local treatment;
- Have received systemic chemotherapy, but does not include treatment for locally advanced disease as a part of multimodal treatment Chemotherapy (the end of this treatment must be more than 6 months after the first trial medication); Note: Multimodal therapy includes induction chemotherapy, concurrent radiotherapy and chemotherapy and adjuvant chemotherapy.
- Locally advanced head and neck squamous cell carcinoma multimodal treatment is completed within 6 months of disease progression;
- Have received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or targeting effects in the past Any other antibody or drug immunotherapy in T cell co-stimulation or immune checkpoint pathway;
- Other malignant tumors have occurred within 5 years or at the same time during the current period, except for cured cervical carcinoma in situ, non- Skin cancer of melanoma or other tumors/cancers that have undergone radical treatment and have no signs of disease for at least 5 years;
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 |
|---|---|---|
| Pembrolizumab combined with ChemotherapyAlso: keytruda and ChemotherapyPembrolizumab (formerly lambrolizumab, brand name Keytruda) is a humanized antibody used in cancer Chemotherapy regimen is selected by the investigator immunotherapy. This includes to treat melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, and stomach cancer. | Drug | Pembrolizumab combined with Chemotherapy |
Primary outcome
objective response rate(ORR)
Time frame: 18 weeks
To evaluate the objective response rate of pembrolizumab combined with chemotherapy in the first-line treatment of Chinese patients with recurrent and or metastatic head and neck squamous cell carcinoma
5 secondary outcomes
progression free survival(PFS)
Time frame: 4 year
disease control rate (DCR)
Time frame: 4 year
duration of response (DOR)
Time frame: 4 year
progression free survival rate(PFS rate)
Time frame: 6 months and 12 months
overall survival (OS)
Time frame: 4 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 28 Jan 2025.
- Individual participant dataSharing planned: No
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Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
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Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
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RecruitingPhase 1/2
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Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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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.
Yuankai Shi, MD principal investigator
Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab combined with Chemotherapy in people with Head and Neck Squamous Cell Carcinoma, run by Yuankai Shi 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 14 inclusion and 34 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 28 Jan 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yuankai Shi, MD (+86-10-87788293, syuankaipumc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate(ORR) (time frame: 18 weeks). 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 28 Jan 2025.