Efficacy and SafetyPhase 2NCT06218004
Envafolimab Combined With Chemotherapy in Neoadjuvant and Conversion Therapy for Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Envafolimab combined with chemotherapy in people with Efficacy and Safety, run by Hairong Liu.
Trial summary
This study is a prospective clinical study. The purpose is to explore the efficacy and safety of Envafolimab combined with chemotherapy for neoadjuvant treatment or conversion treatment of locally advanced head and neck squamous cell carcinoma, and to observe the correlation between the immune microenvironment and the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Efficacy and Safety
- What is being tested?
- Envafolimab combined with chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2024to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG score 0-2.
- Age 18-80 years old, male or female.
- Histologically confirmed locally advanced head and neck squamous cell carcinoma, including nasopharyngeal, oropharyngeal, laryngeal and hypopharyngeal cancers.（Group A enrollment criteria: locally advanced nasopharyngeal carcinoma T3/T4a any N. Locally advanced oropharyngeal carcinoma T3/T4a any N. Locally advanced laryngeal cancer T3/T4a any N, locally advanced hypopharyngeal cancer T3/T4a any N. Surgery is available as assessed by an otolaryngologist, but the scope of surgery is large and neoadjuvant treatment is required.Group B enrollment criteria: locally advanced nasopharyngeal carcinoma T4b any N. Locally advanced oropharyngeal carcinoma T4b any N. Locally advanced laryngeal cancer T4b any N, locally advanced hypopharyngeal cancer T4b any N. Patients who are evaluated by an otolaryngologist as unable to undergo surgery at present are treated with conversion therapy.）
- Estimated survival ≥ 3 months.
- Have at least one measurable lesion according to iRECIST criteria (spiral CT scan ≥ 10 mm).
- Hematology: leukocytes ≥ 4000/μL, neutrophils ≥ 2.000/μL, hemoglobin ≥ 9 g/dL, platelets ≥ 90000/μL.
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- Liver function: ALT, AST, 1.5 times the upper limit of normal (ULN) <, total bilirubin < 1.5× ULN.
- Renal function: serum creatinine < 1.5×ULN.
- Patient has signed an informed notice and is willing and able to comply with the study plan's visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Known allergy to any of the drugs in the study;
- Pregnant or lactating women;
- Participated in other drug clinical trials within 4 weeks before the start of the study;
- Those who have undergone major surgery within 28 days;
- As judged by the investigator, the patient's tumor has a very high risk of affecting important blood vessels and causing fatal hemorrhage during treatment;
- Have a history of severe bleeding, and have any bleeding events with a severity grade of 3 or above in CTCAE4.0 within 4 weeks prior to screening;
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- Patients with hypertension that cannot be well controlled by a single antihypertensive drug (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg);
- Clinically significant (e.g., active) cardiovascular disease - such as cerebrovascular accident (6 months prior to ≤ randomization), myocardial infarction (6 months prior ≤to randomization), unstable angina pectoris, New York College of Cardiology (NYHA) grade II or above congestive heart failure, or severe arrhythmia that cannot be controlled with medication or has a potential impact on the trial treatment;
- Arterior/venous thrombosis events within 6 months before the start of screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except for those who have recovered due to intravenous thrombosis caused by intravenous catheterization in the early stage of chemotherapy and judged by the investigator) and pulmonary embolism;
- Renal insufficiency: urine routine proteinuria >2+, and confirmed 24-hour urine protein quantification > 1.0 g;
- Long-term unhealed wounds or fractures with incomplete healing;
- Those who have been treated with strong CYP3A4 inhibitors within one week before enrollment, or have been treated with strong CYP3A4 inducers within 2 weeks before participating in the study;
- Symptomatic brain metastases (confirmed or suspected);
- Presence of severe or uncontrolled infection;
- Those who have a history of psychotropic drug abuse and cannot be quit or have a history of mental disorders;
- Have a history of immunodeficiency, including a positive HIV test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation, and have a history of autoimmune diseases.
- Use of excessive high doses of glucocorticoids within 4 weeks.
- Patients with previous and current objective evidence of history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe impairment of lung function, etc.;
- According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Clinical Study of Envafolimab Combined With Chemotherapy in Neoadjuvant and Conversion Therapy for Head and Neck Squamous Cell Carcinoma
This study is a prospective clinical study. The purpose is to explore the efficacy and safety of Envafolimab combined with chemotherapy for neoadjuvant treatment or conversion treatment of locally advanced head and neck squamous cell carcinoma, and to observe the correlation between the immune microenvironment and the efficacy of immune checkpoint inhibitors, genetic changes and the efficacy in head and neck squamous cell carcinoma .
Read the detailed description
This study is a prospective clinical study. The purpose is to explore the efficacy and safety of Envafolimab combined with chemotherapy for neoadjuvant treatment or conversion treatment of locally advanced head and neck squamous cell carcinoma, and to observe the correlation between the immune microenvironment and the efficacy of immune checkpoint inhibitors, genetic changes and the efficacy in head and neck squamous cell carcinoma .
After the patient signed the informed consent form, he was screened to meet the enrollment criteria and received envafolimab combined with chemotherapy according to the patient's condition.
For the first imaging evaluation, if surgical treatment can be performed, neoadjuvant therapy is required to be enrolled in group A, and 3 cycles of chemotherapy combined with envafolimab are given for re-imaging after treatment. The iRECIST criteria were used to evaluate and observe the ORR and PRO (University of Washington Head and Neck Tumor Quality of Life Scale 4th Edition (UW-QOL V4.0)), if the clinical status of the subjects is stable and the investigator evaluates that surgical treatment is feasible, the subjects can be treated with surgery, and the MPR and pCR rates are observed in postoperative pathology. After the operation, the next treatment plan (adjuvant therapy or observation) is decided according to the patient's pathological condition. If the patient develops PD during the treatment period, the subject should discontinue the study treatment.
If the imaging evaluation cannot be surgically treated, conversion therapy can be used to enroll in group B, and 3 cycles of chemotherapy combined with envafolimab can be given for re-imaging after treatment. The iRECIST criteria were used to evaluate and observe the ORR and PRO (University of Washington Head and Neck Tumor Quality of Life Scale 4th Edition (UW-QOL V4.0)), if the clinical status of the subjects is stable and the investigator evaluates that surgical treatment is feasible, the subjects can be treated with surgery, and the MPR and pCR rates are observed in postoperative pathology. After the operation, the next treatment plan (adjuvant therapy or observation) is decided according to the patient's pathological condition. If the patient develops PD during the follow-up period, the subject should discontinue the study treatment.
- Conditions
- Efficacy and Safety
- Being tested
- Envafolimab combined with chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Envafolimab combined with chemotherapyDrug
Also called Envafolimab
envafolimab: 150 mg once every 1 week for 8 doses subcutaneously on day 1 Chemotherapy: nab-paclitaxel + cisplatin/carboplatin 3 cycles; Albumin paclitaxel 260 mg/m2, cisplatin 75 mg/m2 divided into 3 days, carboplatin AUC 5 applied on the first day.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Neoadjuvant treatment group | Experimental | envafolimab: 150 mg once every 1 week for 8 doses subcutaneously on day 1 Chemotherapy: nab-paclitaxel + cisplatin/carboplatin 3 cycles; Albumin paclitaxel 260 mg/m2, cisplatin 75 mg/m2 divided into 3 days, carboplatin AUC 5 applied on the first day. Receives: Drug: Envafolimab combined with chemotherapy |
| Group B: Conversion therapy group | Experimental | envafolimab: 150 mg once every 1 week for 8 doses subcutaneously on day 1 Chemotherapy: nab-paclitaxel + cisplatin/carboplatin 3 cycles; Albumin paclitaxel 260 mg/m2, cisplatin 75 mg/m2 divided into 3 days, carboplatin AUC 5 applied on the first day. Receives: Drug: Envafolimab combined with chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR（Objective response rate）
Proportion of patients whose tumors have shrunk to a prespecified value and are able to maintain the minimum time limit
Measured: 12 months
Secondary outcomes (3)
pCR
It is defined as the absence of residual infiltrates in the tissues after neoadjuvant therapy induction and surgical treatment, and no lesions can be detected in lymph node samples.The proportion of pathological complete response was achieved .
Measured: immediately after the surgery
MPR
Defined as tumor regression with pathologic residual tumor ≤ 10% in neoadjuvant therapy induction and surgical treatment.The proportion of pathologic residual tumor ≤ 10% was achieved .
Measured: immediately after the surgery
Safety of treatment
This includes the incidence of adverse events (AEs) and serious adverse events (SAEs), and the incidence of AEs/SAEs leading to treatment discontinuation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start25 Jan 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy and SafetyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hairong Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hairong Liu, Qianfoshan Hospital
- Investigators
- Hairong Liu, Doctor, Principal investigator, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218004
- Sponsor's protocol ID
- YXLL-KY-2023(112)
- Status last verified
- Jan 2024
- First submitted
- 15 Dec 2023
- Last updated
- 23 Jan 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 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study of Envafolimab Combined With Chemotherapy in Neoadjuvant and Conversion Therapy for Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06218004
- Acronym / sponsor ID
- YXLL-KY-2023(112)
- Conditions
- Efficacy and Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hairong LiuUniversity, hospital or other
- Study start
- 25 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Jan 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 prospective clinical study. The purpose is to explore the efficacy and safety of Envafolimab combined with chemotherapy for neoadjuvant treatment or conversion treatment of locally advanced head and neck squamous cell carcinoma, and to observe the correlation between the immune microenvironment and the efficacy of immune checkpoint inhibitors, genetic changes and the efficacy in head and neck squamous cell carcinoma .
Detailed description
This study is a prospective clinical study. The purpose is to explore the efficacy and safety of Envafolimab combined with chemotherapy for neoadjuvant treatment or conversion treatment of locally advanced head and neck squamous cell carcinoma, and to observe the correlation between the immune microenvironment and the efficacy of immune checkpoint inhibitors, genetic changes and the efficacy in head and neck squamous cell carcinoma .
After the patient signed the informed consent form, he was screened to meet the enrollment criteria and received envafolimab combined with chemotherapy according to the patient's condition.
For the first imaging evaluation, if surgical treatment can be performed, neoadjuvant therapy is required to be enrolled in group A, and 3 cycles of chemotherapy combined with envafolimab are given for re-imaging after treatment. The iRECIST criteria were used to evaluate and observe the ORR and PRO (University of Washington Head and Neck Tumor Quality of Life Scale 4th Edition (UW-QOL V4.0)), if the clinical status of the subjects is stable and the investigator evaluates that surgical treatment is feasible, the subjects can be treated with surgery, and the MPR and pCR rates are observed in postoperative pathology. After the operation, the next treatment plan (adjuvant therapy or observation) is decided according to the patient's pathological condition. If the patient develops PD during the treatment period, the subject should discontinue the study treatment.
If the imaging evaluation cannot be surgically treated, conversion therapy can be used to enroll in group B, and 3 cycles of chemotherapy combined with envafolimab can be given for re-imaging after treatment. The iRECIST criteria were used to evaluate and observe the ORR and PRO (University of Washington Head and Neck Tumor Quality of Life Scale 4th Edition (UW-QOL V4.0)), if the clinical status of the subjects is stable and the investigator evaluates that surgical treatment is feasible, the subjects can be treated with surgery, and the MPR and pCR rates are observed in postoperative pathology. After the operation, the next treatment plan (adjuvant therapy or observation) is decided according to the patient's pathological condition. If the patient develops PD during the follow-up period, the subject should discontinue the study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Neoadjuvant treatment group | Experimental | Drug: Envafolimab combined with chemotherapyenvafolimab: 150 mg once every 1 week for 8 doses subcutaneously on day 1 Chemotherapy: nab-paclitaxel + cisplatin/carboplatin 3 cycles; Albumin paclitaxel 260 mg/m2, cisplatin 75 mg/m2 divided into 3 days, carboplatin AUC 5 applied on the first day. |
| Group B: Conversion therapy group | Experimental | Drug: Envafolimab combined with chemotherapyenvafolimab: 150 mg once every 1 week for 8 doses subcutaneously on day 1 Chemotherapy: nab-paclitaxel + cisplatin/carboplatin 3 cycles; Albumin paclitaxel 260 mg/m2, cisplatin 75 mg/m2 divided into 3 days, carboplatin AUC 5 applied on the first day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ECOG score 0-2.
- Age 18-80 years old, male or female.
- Histologically confirmed locally advanced head and neck squamous cell carcinoma, including nasopharyngeal, oropharyngeal, laryngeal and hypopharyngeal cancers.（Group A enrollment criteria: locally advanced nasopharyngeal carcinoma T3/T4a any N. Locally advanced oropharyngeal carcinoma T3/T4a any N. Locally advanced laryngeal cancer T3/T4a any N, locally advanced hypopharyngeal cancer T3/T4a any N. Surgery is available as assessed by an otolaryngologist, but the scope of surgery is large and neoadjuvant treatment is required.Group B enrollment criteria: locally advanced nasopharyngeal carcinoma T4b any N. Locally advanced oropharyngeal carcinoma T4b any N. Locally advanced laryngeal cancer T4b any N, locally advanced hypopharyngeal cancer T4b any N. Patients who are evaluated by an otolaryngologist as unable to undergo surgery at present are treated with conversion therapy.）
- Estimated survival ≥ 3 months.
- Have at least one measurable lesion according to iRECIST criteria (spiral CT scan ≥ 10 mm).
Key exclusion criteria (19 listed)
- Known allergy to any of the drugs in the study;
- Pregnant or lactating women;
- Participated in other drug clinical trials within 4 weeks before the start of the study;
- Those who have undergone major surgery within 28 days;
- As judged by the investigator, the patient's tumor has a very high risk of affecting important blood vessels and causing fatal hemorrhage during treatment;
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 |
|---|---|---|
| Envafolimab combined with chemotherapyAlso: Envafolimabenvafolimab: 150 mg once every 1 week for 8 doses subcutaneously on day 1 Chemotherapy: nab-paclitaxel + cisplatin/carboplatin 3 cycles; Albumin paclitaxel 260 mg/m2, cisplatin 75 mg/m2 divided into 3 days, carboplatin AUC 5 applied on the first day. | Drug | Group A: Neoadjuvant treatment group, Group B: Conversion therapy group |
Primary outcome
ORR（Objective response rate）
Time frame: 12 months
Proportion of patients whose tumors have shrunk to a prespecified value and are able to maintain the minimum time limit
3 secondary outcomes
pCR
Time frame: immediately after the surgery
MPR
Time frame: immediately after the surgery
Safety of treatment
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 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. This study is not recruiting at the moment.
Hairong Liu, Doctor principal investigator
Qianfoshan Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Envafolimab combined with chemotherapy in people with Efficacy and Safety, run by Hairong Liu.
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 19 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: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hairong Liu, Doctor (15588889276, Lqw6989@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR（Objective response rate） (time frame: 12 months). 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 23 Jan 2024.