Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 1/2NCT06572514
De-escalation Radiation Strategy After NAC in Combination With ICI in LAHNSCC
A Phase 1/2 study testing immunotherapy：pembrolizumab；chemo：albumin-bound paclitaxel and cisplatin in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Ruijin Hospital at 1 site in China.
Trial summary
This study is a single-arm exploratory study conducted in LAHNSCC. Eligible patients received two cycles of pembrolizumab immunotherapy in combination with albumin-bound paclitaxel and cisplatin induction chemotherapy, followed by definitive concurrent radiochemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- What is being tested?
- immunotherapy：pembrolizumab；chemo：albumin-bound paclitaxel and cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2023to Apr 2027
- Phase
- Phase 1/2
- 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
- ≥18 years old, with medical decision-making capacity
- Signed informed consent
- ECOG score of 0-1
- Pathologically diagnosed with oral cancer, oropharyngeal cancer, laryngeal cancer, or hypopharyngeal cancer
- Exclusion of distant metastasis
- Clearly evaluable lesion (per RECIST 1.1 criteria)
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- Expected life span ≥6 months
- Laboratory test results meet the following requirements: WBC ≥ 3×10^9/L, ANC ≥ 2.0×10^9/L, PLT ≥ 80×10^9/L, Hb ≥ 80g/L (according to the normal standards of the central laboratory); Liver function: Total bilirubin, ALT, and AST all ≤ 1.5x UNL (upper normal limit); AST (SGOT)/ALT (SGPT) ≤ 2.5 x IULN (upper normal limit); Kidney function: Cr ≤ 1.5x UNL (upper normal limit), and creatinine clearance rate ≥ 60 ml/min (calculated using the Cockcroft and Gault formula); Thyroid function T3 and T4 within the normal range (hypothyroidism can be corrected with oral thyroid hormone supplementation); Heart function: All three cardiac enzymes and pro-BNP within the normal range, no history of heart attack; Adrenal function: Normal cortisol secretion function or correctable based on endocrine assessment
- HBV-infected patients with HBV-DNA copy numbers less than 500 IU/ml
- No history of other malignant tumors in the past 5 years (excluding basal cell carcinoma of the skin and thyroid cancer).
Who cannot join
- No indications for curative radiotherapy or contraindications to radiochemotherapy.
- Clinical factors identified by the investigator that could potentially affect the completion of the study protocol (such as bleeding, active infection, or mental factors).
- Patients requiring long-term maintenance steroid therapy (including oral and intravenous use); local use or inhalation can be included in the study.
- Previous history of autoimmune diseases or in the active phase of the disease [including but not limited to inflammatory bowel disease (IBD), rheumatoid arthritis, autoimmune hepatitis, systemic sclerosis (scleroderma and its variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (such as Guillain-Barré syndrome)], vitiligo, and correctable endocrine deficiencies such as hypothyroidism and physiological cortisol deficiency can be included in the study and are not exclusion criteria.
- History of active tuberculosis or non-infectious pneumonia or any clinical evidence.
- Active phase of viral hepatitis, HBV DNA > 500 IU/ml.
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- Acquired Immunodeficiency Syndrome (AIDS).
- Concurrent severe medical conditions (including heart diseases) with coexisting diseases or conditions affecting the patient's normal enrollment or safety during the study.
- Prior immunotherapy for other tumors.
- History of other malignant tumors within 5 years (excluding cured basal cell carcinoma of the skin or thyroid cancer).
- Pregnant or lactating women.
- Concurrently suffering from other malignant tumors.
- Cannot or unwilling to sign the informed consent form.
- Vaccination within 4 weeks.
- Allergic reaction to the investigational drug.
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
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Yunsheng Gao, M.D., +86-021-64370045 ext. 602400, gys11856@rjh.com.cn
About this study
Official title: The Exploratory Study of the Feasibility of De-escalating Radiation Strategy After NAC in Combination With Immunotherapy in LAHNSCC
This study is a single-arm exploratory study conducted in LAHNSCC. Eligible patients received two cycles of pembrolizumab immunotherapy in combination with albumin-bound paclitaxel and cisplatin induction chemotherapy, followed by definitive concurrent radiochemotherapy. Three months after the completion of radiotherapy, a follow-up examination was conducted, and salvage surgery or systemic therapy was performed as necessary based on the follow-up results.
- Being tested
- immunotherapy：pembrolizumab；chemo：albumin-bound paclitaxel and cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunotherapy：pembrolizumab；chemo：albumin-bound paclitaxel and cisplatinDrug
Also called definitive radiation
The immunotherapy drug was pembrolizumab at a dose of 200 mg, administered on the first day of each cycle every 3 weeks. The induction chemotherapy regimen included albumin-bound paclitaxel at 260 mg/m2 and cisplatin at 75 mg/m2, given every 3 weeks, either concurrently with immunotherapy or on the second day.
| Study group | Role | What they receive |
|---|---|---|
| experimental arm | Experimental | Eligible patients received two cycles of pembrolizumab immunotherapy in combination with albumin-bound paclitaxel and cisplatin induction chemotherapy, followed by definitive concurrent radiochemotherapy. Receives: Drug: immunotherapy：pembrolizumab；chemo：albumin-bound paclitaxel and cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival (PFS) (local-regional recurrence) is defined as the time from enrollment to the occurrence of local or regional lymph node recurrence or death for any reason.
Measured: 1 year
Secondary outcomes (4)
Overall survival (OS)
Overall survival is defined as the time from enrollment to death for any reason
Measured: 3-year
Clinical response rate
Clinical response is defined as the radiological evaluation of tumor regression as partial remission (PR) and complete remission (CR) on imaging assessment three months after the completion of treatment.
Measured: 6 months
Safety(Grade 3-5 AE)
Safety is primarily assessed based on the probability of occurrence of Grade 3-5 adverse effects in different organs according to CTCAE 4.0 (including radiation-related injuries and adverse reactions to immunotherapy).
Measured: 1-year
Quality of life
The assessment of quality of life is conducted using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck Module (EORTC QLQ-H\&N 35), which includes eight domains: pain, swallowing, senses, speech, social eating, social contact, sexuality and single items. Each item is scored on a scale from 0 to 100. A high score for a functional scale or global QOL implies a high level of functioning or global QOL, whereas a high score for a symptom scale or single item implies a high level of symptoms.
Measured: 6 month and 1 year after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start17 Oct 2023
- Primary completionSep 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Ruijin 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GAOYUNSHENG, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572514
- Sponsor's protocol ID
- LAHNSCC-02
- Status last verified
- Aug 2024
- First submitted
- 17 Dec 2023
- Last updated
- 27 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 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exploratory Study of the Feasibility of De-escalating Radiation Strategy After NAC in Combination With Immunotherapy in LAHNSCC
- ClinicalTrials.gov ID
- NCT06572514
- Acronym / sponsor ID
- LAHNSCC-02
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 27 Aug 2024 (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 single-arm exploratory study conducted in LAHNSCC. Eligible patients received two cycles of pembrolizumab immunotherapy in combination with albumin-bound paclitaxel and cisplatin induction chemotherapy, followed by definitive concurrent radiochemotherapy. Three months after the completion of radiotherapy, a follow-up examination was conducted, and salvage surgery or systemic therapy was performed as necessary based on the follow-up results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Drug: immunotherapy：pembrolizumab；chemo：albumin-bound paclitaxel and cisplatinEligible patients received two cycles of pembrolizumab immunotherapy in combination with albumin-bound paclitaxel and cisplatin induction chemotherapy, followed by definitive concurrent radiochemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥18 years old, with medical decision-making capacity
- Signed informed consent
- ECOG score of 0-1
- Pathologically diagnosed with oral cancer, oropharyngeal cancer, laryngeal cancer, or hypopharyngeal cancer
- Exclusion of distant metastasis
Key exclusion criteria (15 listed)
- No indications for curative radiotherapy or contraindications to radiochemotherapy.
- Clinical factors identified by the investigator that could potentially affect the completion of the study protocol (such as bleeding, active infection, or mental factors).
- Patients requiring long-term maintenance steroid therapy (including oral and intravenous use); local use or inhalation can be included in the study.
- Previous history of autoimmune diseases or in the active phase of the disease [including but not limited to inflammatory bowel disease (IBD), rheumatoid arthritis, autoimmune hepatitis, systemic sclerosis (scleroderma and its variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (such as Guillain-Barré syndrome)], vitiligo, and correctable endocrine deficiencies such as hypothyroidism and physiological cortisol deficiency can be included in the study and are not exclusion criteria.
- History of active tuberculosis or non-infectious pneumonia or any clinical evidence.
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 |
|---|---|---|
| immunotherapy：pembrolizumab；chemo：albumin-bound paclitaxel and cisplatinAlso: definitive radiationThe immunotherapy drug was pembrolizumab at a dose of 200 mg, administered on the first day of each cycle every 3 weeks. The induction chemotherapy regimen included albumin-bound paclitaxel at 260 mg/m2 and cisplatin at 75 mg/m2, given every 3 weeks, either concurrently with immunotherapy or on the second day. | Drug | experimental arm |
Primary outcome
Progression-free survival (PFS)
Time frame: 1 year
Progression-free survival (PFS) (local-regional recurrence) is defined as the time from enrollment to the occurrence of local or regional lymph node recurrence or death for any reason.
4 secondary outcomes
Overall survival (OS)
Time frame: 3-year
Clinical response rate
Time frame: 6 months
Safety(Grade 3-5 AE)
Time frame: 1-year
Quality of life
Time frame: 6 month and 1 year after the treatment
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 27 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 1/2 study testing immunotherapy：pembrolizumab；chemo：albumin-bound paclitaxel and cisplatin in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Ruijin 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 10 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 27 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Yujie Wang, M.D. (+86 02164370045 ext. 602400, wyj12054@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 1 year). 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 27 Aug 2024.