Head and Neck Squamous Cell CarcinomaPhase 2NCT06100497
Efficacy and Safety of PD-1 Plus Chemotherapy in Poorly Differentiated Locally Advanced (LA) HNSCC
A Phase 2 study testing Pembrolizumab, Cisplatin and Paclitaxel-albumin in people with Head and Neck Squamous Cell Carcinoma, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Patients with locally advanced (stage III to stage IVB) poorly differentiated head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) who meet the inclusion criteria will have their blood samples collected, tumor tissue samples or patient paraffin tissue, and slides for comprehensive genomic… 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, Cisplatin and Paclitaxel-albumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 31 Oct 2028
- 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
- Patients with locally advanced (III-IVB) poorly differentiated head and neck tumors (hypopharyngeal cancer, laryngeal cancer, oropharyngeal cancer, nasal cavity and sinus cancer, excluding nasopharyngeal cancer) with a confirmed diagnosis by histology and/or cytology;
- Patients who can receive systemic treatment or PD-1/L1 monotherapy before treatment;
- Patients in arm2 must be evaluated as having resectable tumors before treatment;
- The investigator believes that the patient can safely receive PD-1 combined with platinum-based and albumin-bound paclitaxel treatment;
- Age ≥ 18 years;
- ECOG (Eastern Cooperative Oncology Group) 0-1；
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- Measurable disease defined by RECIST v1.1;
- Adequate bone marrow reserve and organ function: absolute neutrophil count (ANC) ≥ 1,000/μL, platelets ≥ 75,000/μL, hemoglobin ≥ 8g/dL, no transfusion or erythropoietin (EPO) dependence (within 7 days of assessment);
- Renal function: serum creatinine ≤ 1.5X upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 60mL/min, creatinine level > 1.5X institutional ULN. (GFR can also be used instead of creatinine or CrCl). Creatinine clearance should be calculated according to institutional standards;
- Liver function: For subjects with total bilirubin levels >1.5 ULN, serum total bilirubin ≤1.5X ULN or direct bilirubin ≤ULN; For patients with liver metastasis, aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤2.5X ULN or ≤5X ULN; Albumin > 2.5 mg/dL;
- Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5X ULN, if subjects require anticoagulant therapy, PT or PTT (partial thromboplastin time) should be within the allowable range of anticoagulant use;
- Women should agree to use contraception during the study and for 6 months after the end of the study (such as intrauterine devices (IUDs), contraceptive pills, or condoms); Within 7 days before study enrollment, serum or urine pregnancy test should be negative, and patients must be non-lactating; Men should agree to use contraception during the study and for 6 months after the end of the study.
Who cannot join
- Patients who have previously received PD-1/L1 combined chemotherapy drugs;
- Patients with a history of other malignant tumors (including unknown primary) within the past 5 years. Note: Excluding stage 1 or 2 skin basal/squamous cell carcinoma or in situ carcinoma receiving potentially curative treatment;
- Patients who cannot tolerate postoperative radiotherapy;
- Patients known to be allergic to the study drug or its active ingredients or excipients;
- Patients with any unstable systemic diseases, including but not limited to: severe infection, uncontrolled diabetes, unstable angina, cerebrovascular accident or transient ischemic attack, myocardial infarction, congestive heart failure, severe -Patients with underlying immune deficiencies, chronic infections, including HIV, hepatitis, tuberculosis (TB), or autoimmune diseases;
- Patients with potential hematologic issues, including bleeding diathesis, known prior gastrointestinal bleeding requiring intervention within the past 6 months, active pulmonary embolism or deep vein thrombosis (DVT) unstable on anticoagulation regimen;
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- History or evidence of active non-infectious pneumonia;
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease. Subjects with prior treated brain metastases may participate as long as they are stable (no evidence of imaging progression for at least four weeks prior to the first trial treatment and any neurological symptoms have returned to baseline), no new or enlarging brain metastases, and no use of steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, which will be excluded regardless of clinical stability;
- Within 7 days before the first day of the first cycle, at the same time (or receiving) treatment with drugs that may affect drug metabolism;
- Pregnant or breastfeeding, or expecting to become pregnant or give birth during the expected trial period;
- Any uncontrolled concurrent disease, including but not limited to persistent or active infection, symptomatic congestive heart failure, unstable angina, arrhythmia;
- Screening EKG> 475 ms prolonged corrected QT (QTc) interval;
- Ejection fraction <40% by 2D echocardiogram (ECHO) during screening;
- Any serious medical or mental illness/symptoms, including substance use disorders, may interfere with or limit compliance with study requirements/treatments in the investigator's judgment;
- Having active autoimmune diseases requiring systemic treatment in the past 2 years (even with disease-modifying agents, corticosteroids, or immunosuppressive drugs). Alternative therapies (e.g., thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered a form of systemic treatment.
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 Affiliated to Capital Medical University
Beijing, Beijing Municipality, 10000
Xiaohong Chen, Doctor, +86 13911071002
About this study
Official title: Efficacy and Safety of PD-1 Inhibitor Combined With Chemotherapy in Locally Advanced (III-IVB) Poorly Differentiated Head and Neck Squamous Cell Carcinoma: a Multi Cohort, Prospective Phase II Study
Patients with locally advanced (stage III to stage IVB) poorly differentiated head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) who meet the inclusion criteria will have their blood samples collected, tumor tissue samples or patient paraffin tissue, and slides for comprehensive genomic sequencing and analysis. The study is divided into two groups. Arm1 group: Patients with stage IVB (T4bNxM0) poorly differentiated head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) will receive PD-1 combined with platinum-based chemotherapy and albumin-bound paclitaxel (dose according to the drug instructions) for 2 to 3 cycles (determined by the researcher based on tumor shrinkage). If the imaging achieves complete response (CR) or partial response (PR), suitable patients will undergo surgical treatment. Patients who are not suitable for surgery or have stable disease (SD)/progressive disease (PD) will receive concurrent chemoradiotherapy or concurrent chemoradiotherapy combined with PD-1 treatment (up to a total of 17 cycles). Arm2 group: Patients with stage III and IVA (T3NxM0, T4aNxM0) poorly differentiated head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) will receive PD-1 combined with platinum-based chemotherapy and albumin-bound paclitaxel (dose according to the drug instructions) for 2 cycles. Patients who undergo surgery within 2 weeks will receive PD-1 monotherapy maintenance treatment or low-dose radiotherapy followed by PD-1 monotherapy maintenance treatment based on pathological results. Patients who do not achieve pathological complete response (pCR) and have positive surgical margins or extracapsular extension will receive concurrent chemoradiotherapy followed by PD-1 maintenance treatment (up to a total of 17 cycles). Patients without high-risk factors will receive PD-1 maintenance treatment after radiotherapy (up to a total of 17 cycles). After completion of treatment, all patients will be followed up every 3 months for 1 year. Subsequently, patients will be followed up every 6 months for 3 years. Thereafter, patients will be followed up annually. Patient recurrence and survival data will be recorded.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- Pembrolizumab, Cisplatin, Paclitaxel-albumin
- 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
Mainly used for neoadjuvant treatment and subsequent adjuvant or maintenance treatment
CisplatinDrug
Mainly used for neoadjuvant treatment and concurrent chemoradiotherapy
Paclitaxel-albuminDrug
Also called albumin paclitaxel
Mainly used for neoadjuvant treatment
| Study group | Role | What they receive |
|---|---|---|
| Stage IVB cohort | Experimental | patients must undergo evaluation after receiving 2 cycles of PD-1 (pembrolizumab, 200mg, IV, Q3W) combined with platinum-based (cisplatin: 75 mg/m2, IV, Q3W) and albumin paclitaxel (260mg/m2, IV, Q3W) treatment (Arm 1 may receive a third cycle of treatment based on tumor regression). if achieving CR/PR on imaging, suitable for surgical treatment, not suitable for surgery or SD/PD patients, subsequent synchronous chemoradiotherapy or synchronous chemoradiotherapy combined with PD-1 (pembrolizumab) treatment (total of no more than 17 cycles). Receives: Drug: Pembrolizumab; Drug: Cisplatin; Drug: Paclitaxel-albumin |
| Stage III-IVA cohort | Experimental | patients with stage III and IVA (T3NxM0, T4aNxM0) receive PD-1 (pembrolizumab, 200mg, IV, Q3W) combined with platinum-based chemotherapy (cisplatin: 75 mg/m2, IV, Q3W) and albumin-bound paclitaxel (260mg/m2, IV, Q3W) for 2 cycles. Patients who undergo surgery within 2 weeks based on pathological results are given PD-1 monotherapy maintenance treatment or low-dose radiotherapy followed by PD-1 monotherapy maintenance treatment if they achieve pathological complete response (pCR). Non-pCR patients with positive surgical margins or extracapsular extension after surgery receive PD-1 maintenance treatment after concurrent chemoradiotherapy (up to a maximum of 17 cycles). Patients without high-risk factors receive PD-1 maintenance treatment after radiotherapy (up to a maximum of 17 cycles). Receives: Drug: Pembrolizumab; Drug: Cisplatin; Drug: Paclitaxel-albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The proportion of subjects with best overall response (BOR) assessed as complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.
Measured: 6 month
Secondary outcomes (4)
Progression-free survival (PFS)
Defined as the time from randomization to the date of first disease progression or death due to any cause, whichever occurs first.
Measured: 3 years
Disease Control Rate (DCR)
According to RECIST v1.1 criteria, it assesses the proportion of subjects with complete response (CR), partial response (PR), and stable disease (SD) in terms of overall best response (BOR).
Measured: 6 month
Time to objective response (TTR)
Defined as the duration from the start of medication to the date of first documented CR or PR (whichever occurs first). Tumor response is based on confirmed tumor response, and the response date is from the first observation, not the confirmed response.
Measured: 3 years
Duration of Response (DOR)
The duration from the date of first assessment as CR or PR to the date of first assessment as disease progression or death for subjects who achieved complete response or partial response (CR or PR).
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 posted25 Oct 2023
- Study start1 Oct 2023
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2028 (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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100497
- Sponsor's protocol ID
- TR-001
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2023
- Last updated
- 9 Aug 2024
- 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 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of PD-1 Inhibitor Combined With Chemotherapy in Locally Advanced (III-IVB) Poorly Differentiated Head and Neck Squamous Cell Carcinoma: a Multi Cohort, Prospective Phase II Study
- ClinicalTrials.gov ID
- NCT06100497
- Acronym / sponsor ID
- TR-001
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 25 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.
Patients with locally advanced (stage III to stage IVB) poorly differentiated head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) who meet the inclusion criteria will have their blood samples collected, tumor tissue samples or patient paraffin tissue, and slides for comprehensive genomic sequencing and analysis. The study is divided into two groups. Arm1 group: Patients with stage IVB (T4bNxM0) poorly differentiated head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) will receive PD-1 combined with platinum-based chemotherapy and albumin-bound paclitaxel (dose according to the drug instructions) for 2 to 3 cycles (determined by the researcher based on tumor shrinkage). If the imaging achieves complete response (CR) or partial response (PR), suitable patients will undergo surgical treatment. Patients who are not suitable for surgery or have stable disease (SD)/progressive disease (PD) will receive concurrent chemoradiotherapy or concurrent chemoradiotherapy combined with PD-1 treatment (up to a total of 17 cycles). Arm2 group: Patients with stage III and IVA (T3NxM0, T4aNxM0) poorly differentiated head and neck squamous cell carcinoma (excluding nasopharyngeal carcinoma) will receive PD-1 combined with platinum-based chemotherapy and albumin-bound paclitaxel (dose according to the drug instructions) for 2 cycles. Patients who undergo surgery within 2 weeks will receive PD-1 monotherapy maintenance treatment or low-dose radiotherapy followed by PD-1 monotherapy maintenance treatment based on pathological results. Patients who do not achieve pathological complete response (pCR) and have positive surgical margins or extracapsular extension will receive concurrent chemoradiotherapy followed by PD-1 maintenance treatment (up to a total of 17 cycles). Patients without high-risk factors will receive PD-1 maintenance treatment after radiotherapy (up to a total of 17 cycles). After completion of treatment, all patients will be followed up every 3 months for 1 year. Subsequently, patients will be followed up every 6 months for 3 years. Thereafter, patients will be followed up annually. Patient recurrence and survival data will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage IVB cohort | Experimental | Drug: Pembrolizumab, Drug: Cisplatin, Drug: Paclitaxel-albuminpatients must undergo evaluation after receiving 2 cycles of PD-1 (pembrolizumab, 200mg, IV, Q3W) combined with platinum-based (cisplatin: 75 mg/m2, IV, Q3W) and albumin paclitaxel (260mg/m2, IV, Q3W) treatment (Arm 1 may receive a third cycle of treatment based on tumor regression). if achieving CR/PR on imaging, suitable for surgical treatment, not suitable for surgery or SD/PD patients, subsequent synchronous chemoradiotherapy or synchronous chemoradiotherapy combined with PD-1 (pembrolizumab) treatment (total of no more than 17 cycles). |
| Stage III-IVA cohort | Experimental | Drug: Pembrolizumab, Drug: Cisplatin, Drug: Paclitaxel-albuminpatients with stage III and IVA (T3NxM0, T4aNxM0) receive PD-1 (pembrolizumab, 200mg, IV, Q3W) combined with platinum-based chemotherapy (cisplatin: 75 mg/m2, IV, Q3W) and albumin-bound paclitaxel (260mg/m2, IV, Q3W) for 2 cycles. Patients who undergo surgery within 2 weeks based on pathological results are given PD-1 monotherapy maintenance treatment or low-dose radiotherapy followed by PD-1 monotherapy maintenance treatment if they achieve pathological complete response (pCR). Non-pCR patients with positive surgical margins or extracapsular extension after surgery receive PD-1 maintenance treatment after concurrent chemoradiotherapy (up to a maximum of 17 cycles). Patients without high-risk factors receive PD-1 maintenance treatment after radiotherapy (up to a maximum of 17 cycles). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with locally advanced (III-IVB) poorly differentiated head and neck tumors (hypopharyngeal cancer, laryngeal cancer, oropharyngeal cancer, nasal cavity and sinus cancer, excluding nasopharyngeal cancer) with a confirmed diagnosis by histology and/or cytology;
- Patients who can receive systemic treatment or PD-1/L1 monotherapy before treatment;
- Patients in arm2 must be evaluated as having resectable tumors before treatment;
- The investigator believes that the patient can safely receive PD-1 combined with platinum-based and albumin-bound paclitaxel treatment;
- Age ≥ 18 years;
Key exclusion criteria (15 listed)
- Patients who have previously received PD-1/L1 combined chemotherapy drugs;
- Patients with a history of other malignant tumors (including unknown primary) within the past 5 years. Note: Excluding stage 1 or 2 skin basal/squamous cell carcinoma or in situ carcinoma receiving potentially curative treatment;
- Patients who cannot tolerate postoperative radiotherapy;
- Patients known to be allergic to the study drug or its active ingredients or excipients;
- Patients with any unstable systemic diseases, including but not limited to: severe infection, uncontrolled diabetes, unstable angina, cerebrovascular accident or transient ischemic attack, myocardial infarction, congestive heart failure, severe -Patients with underlying immune deficiencies, chronic infections, including HIV, hepatitis, tuberculosis (TB), or autoimmune diseases;
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 |
|---|---|---|
| PembrolizumabMainly used for neoadjuvant treatment and subsequent adjuvant or maintenance treatment | Drug | Stage III-IVA cohort, Stage IVB cohort |
| CisplatinMainly used for neoadjuvant treatment and concurrent chemoradiotherapy | Drug | Stage III-IVA cohort, Stage IVB cohort |
| Paclitaxel-albuminAlso: albumin paclitaxelMainly used for neoadjuvant treatment | Drug | Stage III-IVA cohort, Stage IVB cohort |
Primary outcome
Objective response rate (ORR)
Time frame: 6 month
The proportion of subjects with best overall response (BOR) assessed as complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.
4 secondary outcomes
Progression-free survival (PFS)
Time frame: 3 years
Disease Control Rate (DCR)
Time frame: 6 month
Time to objective response (TTR)
Time frame: 3 years
Duration of Response (DOR)
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 9 Aug 2024.
- 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.
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, Cisplatin and Paclitaxel-albumin in people with Head and Neck Squamous Cell Carcinoma, 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 12 inclusion and 15 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 9 Aug 2024. 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 Xiaohong Chen, Doctor (+86 13911071002, trchxh@163.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: 6 month). 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 9 Aug 2024.