Head and Neck Squamous Cell CarcinomaPhase 2NCT06366945
Tirelizumab in Combination With Carboplatin and Polymeric Micellar Paclitaxel for Neoadjuvant Therapy in cN+ HNSCC
A Phase 2 study testing Carboplatin, Tislelizumab and Polymeric Micellar Paclitaxel in people with Head and Neck Squamous Cell Carcinoma and Head and Neck Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
To explore the efficiency and safety of Tislelizumab combinated with carboplatin and polymeric micellar paclitaxel as a new neoadjuvant treatment regimen for resectable HNSCC patients with clinical positive lymph node metastasis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer, HNSCC
- What is being tested?
- Carboplatin, Tislelizumab and Polymeric Micellar Paclitaxel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2024to 30 May 2029
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ECOG Performance Status 0 or 1. Confirmed pathologic and/or cytologic diagnosis of squamous cell carcinoma of head and neck，T2-4N1-3M0（III-IV）（AJCC 8.0） Histological diagnosis of squamous cell carcinoma of the lip, oral cavity, oropharynx, hypopharynx, larynx.
- With measurable target lesions by CT or MRI. Adequate bone marrow function. Adequate renal and liver function. Pregnancy test (for patients of childbearing potential) negative at screening. Signed Written Informed Consent.
Who cannot join
- Patients who pathologically confirmed non-squamous cell carcinoma Patients who has recurrence or distant metastasis Local lesions have been surgically removed Patients who have received systemic anti-cancer therapy, including hormone therapy Patients who have received treatment targeting PD-1 or PD-L1 Patients with active autoimmune disease or a history of autoimmune disease but may relapse(Patients with the following diseases are not excluded and can be further filtered) Controlled type 1 diabetes Hypothyroidism(If it can be controlled with hormone replacement therapy) Controlled celiac disease Skin diseases that do not require systemic treatment such as Vitiligo, Psoriasis and Hair loss.
- Any other disease that is not expected to recur without external triggers Any active malignant tumors within 2 years before treatment, except for the specific cancers being studied in this trial and locally recurring cancers that have been cured (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical in situ Cancer or breast cancer) Any disease requiring systemic treatment with corticosteroids (referring to treatment with a dose higher than 10 mg/day of prednisone or equivalent doses of similar drugs) or other immunosuppressive treatments within 14 days before treatment.
- However, patients who have currently or previously used any of the following steroid regimens can be selected:
- Adrenaline replacement steroids(Prednisone ≤10mg/day or equivalent dose of similar drugs) Local, ophthalmic, intra-articular, intranasal and inhaled corticosteroids which is Systemic absorbed Minimally Prophylactically short-term (≤7 days) use of corticosteroids (for example, allergy to contrast agents) or for the treatment of non-autoimmune conditions (for example, delayed hypersensitivity reactions caused by contact allergens) Uncontrolled diabetes within 14 days before treatment or laboratory abnormalities with potassium, sodium and corrected calcium levels> 1 after standard drug treatment or hypoalbuminemia grade ≥ 3 History of the following diseases: interstitial lung disease, non-infectious pneumonia or uncontrollable diseases, including pulmonary fibrosis, acute lung disease, etc.
- Severe chronic or active infection (including tuberculosis infection, etc.) that required systemic antibiotics, antibacterial or antiviral treatment occurred within 14 days before the first administration of the study drug The patient is known to have been infected with HIV Untreated patients with chronic hepatitis B or HBV carriers with chronic hepatitis B virus (HBV) DNA ≥ 500 IU/mL or active hepatitis C virus carriers (HCV) should be excluded.
- Patients can be selected who is Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA <500 IU/mL) and cured hepatitis C patients.
Show all 9Show fewer
- Any surgery requiring general anesthesia has been performed within 28 days before treatment Have had allogeneic stem cell transplantation or organ transplantation
- Have any of the following cardiovascular risk factors:
- Cardiogenic chest pain within 28 days before treatment(moderate pain that restricts instrumental activities of daily living) Symptomatic pulmonary embolism within 28 days before treatment Acute myocardial infarction within 6 months before treatment Any history of heart failure that has reached Grade III or IV as defined by the New York Heart Association within 6 months before treatment Grade 2 ventricular arrhythmia within 6 months before the first administration of the study drug Have a history of cerebrovascular accident within 6 months before the first administration of the study drug Have a history of severe hypersensitivity to other monoclonal antibodies Patients with treatment toxicity (caused by previous anti-cancer treatments) have not returned to baseline or stabilized, unless it is an AE that is not considered a possible safety risk (such as hair loss, neuropathy, or specific laboratory abnormalities) History of allergic reactions to cisplatin or other platinum-containing compounds Peripheral nerve disease ≥ Grade 2 defined by NCI CTCAE v5.0 standard Have gotten a live vaccine within 4 weeks before treatment(Seasonal flu vaccines are usually inactivated vaccines and are allowed to be used; The vaccine used in the nasal cavity is a live vaccine and is not allowed to be used) Abuse or dependence on alcohol or drugs and Basic medical conditions (including laboratory abnormalities) that are not conducive to the administration of the study drug , affect the interpretation of drug toxicity or AEs, lead to insufficient compliance with the study execution and possible damage The patient participates in another therapeutic clinical study at the same time
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
shule xie, doctor contact
About this study
Official title: Prospective, Single-arm, Phase II Clinical Study of Tirellizumab Combined With Carboplatin and Paclitaxel Polymer Micelles Neoadjuvant Therapy for cN+ Head and Neck Squamous Cell Carcinoma
To explore the efficiency and safety of Tislelizumab combinated with carboplatin and polymeric micellar paclitaxel as a new neoadjuvant treatment regimen for resectable HNSCC patients with clinical positive lymph node metastasis
Read the detailed description
The 5-year overall survival rate of patients with clinical N-positive head and neck squamous cell carcinoma (HNSCC) is less than 50%, and the clinical outcomes of these patients still need improvement.
Immunotherapy, such as PD-1/PD-L1 inhibitors, has shown excellent efficiency in treating malignant tumors. Anti PD-1 therapy has been approved as a first-line treatment for recurrent/metastatic HNSCC. The results of several phase II clinical trials have shown that neoadjuvant immunotherapy for locally advanced resectable HNSCC has been proven to be safe and feasible. However, immunotherapy has a lower MPR rate for locally advanced HNSCC patients with lymph node metastasis.
Paclitaxel has been used as a first-line induction therapy for locally advanced HNSCC and is an important drug in mediating immunogenic death, enhancing the efficacy of immunotherapy. Previous studies on lung cancer have confirmed that nano-paclitaxel has better induction efficacy than solvent paclitaxel and reduces the rate of distant metastasis.
In summary, the investigators designed this study to explore the efficiency and safety of Tislelizumab combinated with carboplatin and polymeric micellar paclitaxel as a new neoadjuvant treatment regimen for patients with clinical N positive resectable HNSCC, aiming to provide a new treatment option for those patients.
- Being tested
- Carboplatin, Tislelizumab, Polymeric Micellar Paclitaxel, Surgical Resection of Primary +/- Neck Dissection, Post-operative radiation therapy
- 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.
CarboplatinDrug
Carboplatin AUC 5 on weeks 1, 3, and 6
TislelizumabDrug
Tislelizumab 200 mg on weeks 3, 6, and 9;if adjuvant immunotherapy is omitted, Tislelizumab will be administered on weeks 1, 3, 6, 9, 12, 15 after surgery
Polymeric Micellar PaclitaxelDrug
Polymeric Micellar Paclitaxel 300mg/mg/m2 on weeks 1, 3 and 6
Surgical Resection of Primary +/- Neck DissectionProcedure or surgery
Twenty-eight days (+ 7 days) following the 3rd cycle of neoadjuvant therapy, patients will then undergo definitive surgical resection of the primary site +/- neck dissection(s).
Post-operative radiation therapyRadiation
Post-operative radiation therapy +/- radiosensitizing agent(s) will be administered per standard-of-care based on pathologic staging of the surgical specimen. If there is an excellent response to treatment with a high degree of downstaging the addition of adjuvant radiation may be omitted if NCCN guidelines are met. If the pathologic assesment following induction systemic therapy and surgery is ypT(pCR 或 MPR) and ypN(pCR) or ypT（ pCR 或 MPR）and ypN（ MPR）without the presence of Serious Adverse Event, adjuvant radiation will not be administered. Otherwise, patients will receive adjuvant RT-based treatment with standard radiation techniques.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Neoadjuvant therapy will be performed for a total of 3 cycles, with 21 days as a cycle, which includes: ① Carboplatin: AUC5, weeks 1, 3, and 6, Q3W; ② Polymeric Micellar Paclitaxel: 300mg/m2, weeks 1, 3, and 6, Q3W for three cycles; ③Tirelizumab: 200 mg weeks 1, 3, and 6, Q3W for three cycles; if adjuvant immunotherapy is omitted, Tirelizumab will be administered on weeks 1, 3, 6, 9, 12, 15 after surgery .Participants with clinical N-positive resectable head and neck squamous cell carcinoma for which standard-of-care management would entail definitive surgery followed by adjuvant radiation +/- concurrent chemotherapy are eligible. Receives: Drug: Carboplatin; Drug: Tislelizumab; Drug: Polymeric Micellar Paclitaxel; Procedure: Surgical Resection of Primary +/- Neck Dissection; Radiation: Post-operative radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response (MPR) rate of metastatic lymph nodes
the proportion of cN+ patients with the percentage of residual viable tumor cells in the tumor bed of metastatic lymph nodes less than 10%
Measured: 10days after surgery
Secondary outcomes (8)
Major pathological response (MPR) rate of primary tumor
the proportion of cN+ patients with the percentage of residual viable tumor cells in the tumor bed of primary tumors less than 10%
Measured: 10days after surgery
Event-free survival (EFS)
In cancer, the length of time after primary treatment for a cancer ends that the patient remains free of certain complications or events that the treatment was intended to prevent or delay.
Measured: 1 years and 3 years
Overall survival（OS）
The time(years) from day 1 of study treatment until death from any cause.
Measured: 1 years and 3 years
Incidence of treatment-related adverse events
CTCAE 5.0
Measured: from the first day of treatment to 30 days after surgery；if adjuvant immotherapy is omitted, time frame is from the first day of treatment to 30 days after last administration
EORTC QLQ-C30
Quality of life evaluation
Measured: from 1 week before treatment to 30 days after surgery
pathological downstaging rate
Percentage of patients with tumor downstaging(pathological stage≦ ypT1N0M0)
Measured: 10days after surgery
Distant metastasis-free survival(DMFS) rate
The DMFS rate is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
Measured: 1 year and 3 year
logical regional-free survival(LRFS) rate
The LRFS rate is evaluated and calculated from the date of random assignment until the day of first logical regional metastases or until the date of the last follow-up visit.
Measured: 1 year and 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start20 Apr 2024 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 May 2029 (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 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jinsong li, doctor, Study director, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366945
- Sponsor's protocol ID
- SYSKY-2024-157-02
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 16 Apr 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 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-arm, Phase II Clinical Study of Tirellizumab Combined With Carboplatin and Paclitaxel Polymer Micelles Neoadjuvant Therapy for cN+ Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06366945
- Acronym / sponsor ID
- SYSKY-2024-157-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 20 Apr 2024 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 16 Apr 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.
To explore the efficiency and safety of Tislelizumab combinated with carboplatin and polymeric micellar paclitaxel as a new neoadjuvant treatment regimen for resectable HNSCC patients with clinical positive lymph node metastasis
Detailed description
The 5-year overall survival rate of patients with clinical N-positive head and neck squamous cell carcinoma (HNSCC) is less than 50%, and the clinical outcomes of these patients still need improvement.
Immunotherapy, such as PD-1/PD-L1 inhibitors, has shown excellent efficiency in treating malignant tumors. Anti PD-1 therapy has been approved as a first-line treatment for recurrent/metastatic HNSCC. The results of several phase II clinical trials have shown that neoadjuvant immunotherapy for locally advanced resectable HNSCC has been proven to be safe and feasible. However, immunotherapy has a lower MPR rate for locally advanced HNSCC patients with lymph node metastasis.
Paclitaxel has been used as a first-line induction therapy for locally advanced HNSCC and is an important drug in mediating immunogenic death, enhancing the efficacy of immunotherapy. Previous studies on lung cancer have confirmed that nano-paclitaxel has better induction efficacy than solvent paclitaxel and reduces the rate of distant metastasis.
In summary, the investigators designed this study to explore the efficiency and safety of Tislelizumab combinated with carboplatin and polymeric micellar paclitaxel as a new neoadjuvant treatment regimen for patients with clinical N positive resectable HNSCC, aiming to provide a new treatment option for those patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Carboplatin, Drug: Tislelizumab, Drug: Polymeric Micellar Paclitaxel, Procedure: Surgical Resection of Primary +/- Neck Dissection, Radiation: Post-operative radiation therapyNeoadjuvant therapy will be performed for a total of 3 cycles, with 21 days as a cycle, which includes: ① Carboplatin: AUC5, weeks 1, 3, and 6, Q3W; ② Polymeric Micellar Paclitaxel: 300mg/m2, weeks 1, 3, and 6, Q3W for three cycles; ③Tirelizumab: 200 mg weeks 1, 3, and 6, Q3W for three cycles; if adjuvant immunotherapy is omitted, Tirelizumab will be administered on weeks 1, 3, 6, 9, 12, 15 after surgery .Participants with clinical N-positive resectable head and neck squamous cell carcinoma for which standard-of-care management would entail definitive surgery followed by adjuvant radiation +/- concurrent chemotherapy are eligible. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females ECOG Performance Status 0 or 1. Confirmed pathologic and/or cytologic diagnosis of squamous cell carcinoma of head and neck，T2-4N1-3M0（III-IV）（AJCC 8.0） Histological diagnosis of squamous cell carcinoma of the lip, oral cavity, oropharynx, hypopharynx, larynx.
- With measurable target lesions by CT or MRI. Adequate bone marrow function. Adequate renal and liver function. Pregnancy test (for patients of childbearing potential) negative at screening. Signed Written Informed Consent.
Key exclusion criteria (9 listed)
- Patients who pathologically confirmed non-squamous cell carcinoma Patients who has recurrence or distant metastasis Local lesions have been surgically removed Patients who have received systemic anti-cancer therapy, including hormone therapy Patients who have received treatment targeting PD-1 or PD-L1 Patients with active autoimmune disease or a history of autoimmune disease but may relapse(Patients with the following diseases are not excluded and can be further filtered) Controlled type 1 diabetes Hypothyroidism(If it can be controlled with hormone replacement therapy) Controlled celiac disease Skin diseases that do not require systemic treatment such as Vitiligo, Psoriasis and Hair loss.
- Any other disease that is not expected to recur without external triggers Any active malignant tumors within 2 years before treatment, except for the specific cancers being studied in this trial and locally recurring cancers that have been cured (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical in situ Cancer or breast cancer) Any disease requiring systemic treatment with corticosteroids (referring to treatment with a dose higher than 10 mg/day of prednisone or equivalent doses of similar drugs) or other immunosuppressive treatments within 14 days before treatment.
- However, patients who have currently or previously used any of the following steroid regimens can be selected:
- Adrenaline replacement steroids(Prednisone ≤10mg/day or equivalent dose of similar drugs) Local, ophthalmic, intra-articular, intranasal and inhaled corticosteroids which is Systemic absorbed Minimally Prophylactically short-term (≤7 days) use of corticosteroids (for example, allergy to contrast agents) or for the treatment of non-autoimmune conditions (for example, delayed hypersensitivity reactions caused by contact allergens) Uncontrolled diabetes within 14 days before treatment or laboratory abnormalities with potassium, sodium and corrected calcium levels> 1 after standard drug treatment or hypoalbuminemia grade ≥ 3 History of the following diseases: interstitial lung disease, non-infectious pneumonia or uncontrollable diseases, including pulmonary fibrosis, acute lung disease, etc.
- Severe chronic or active infection (including tuberculosis infection, etc.) that required systemic antibiotics, antibacterial or antiviral treatment occurred within 14 days before the first administration of the study drug The patient is known to have been infected with HIV Untreated patients with chronic hepatitis B or HBV carriers with chronic hepatitis B virus (HBV) DNA ≥ 500 IU/mL or active hepatitis C virus carriers (HCV) should be excluded.
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 |
|---|---|---|
| CarboplatinCarboplatin AUC 5 on weeks 1, 3, and 6 | Drug | treatment group |
| TislelizumabTislelizumab 200 mg on weeks 3, 6, and 9;if adjuvant immunotherapy is omitted, Tislelizumab will be administered on weeks 1, 3, 6, 9, 12, 15 after surgery | Drug | treatment group |
| Polymeric Micellar PaclitaxelPolymeric Micellar Paclitaxel 300mg/mg/m2 on weeks 1, 3 and 6 | Drug | treatment group |
| Surgical Resection of Primary +/- Neck DissectionTwenty-eight days (+ 7 days) following the 3rd cycle of neoadjuvant therapy, patients will then undergo definitive surgical resection of the primary site +/- neck dissection(s). | Procedure or surgery | treatment group |
| Post-operative radiation therapyPost-operative radiation therapy +/- radiosensitizing agent(s) will be administered per standard-of-care based on pathologic staging of the surgical specimen. If there is an excellent response to treatment with a high degree of downstaging the addition of adjuvant radiation may be omitted if NCCN guidelines are met. If the pathologic assesment following induction systemic therapy and surgery is ypT(pCR 或 MPR) and ypN(pCR) or ypT（ pCR 或 MPR）and ypN（ MPR）without the presence of Serious Adverse Event, adjuvant radiation will not be administered. Otherwise, patients will receive adjuvant RT-based treatment with standard radiation techniques. | Radiation | treatment group |
Primary outcome
Major pathological response (MPR) rate of metastatic lymph nodes
Time frame: 10days after surgery
the proportion of cN+ patients with the percentage of residual viable tumor cells in the tumor bed of metastatic lymph nodes less than 10%
8 secondary outcomes
Major pathological response (MPR) rate of primary tumor
Time frame: 10days after surgery
Event-free survival (EFS)
Time frame: 1 years and 3 years
Overall survival（OS）
Time frame: 1 years and 3 years
Incidence of treatment-related adverse events
Time frame: from the first day of treatment to 30 days after surgery；if adjuvant immotherapy is omitted, time frame is from the first day of treatment to 30 days after last administration
EORTC QLQ-C30
Time frame: from 1 week before treatment to 30 days after surgery
pathological downstaging rate
Time frame: 10days after surgery
Distant metastasis-free survival(DMFS) rate
Time frame: 1 year and 3 year
logical regional-free survival(LRFS) rate
Time frame: 1 year and 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 16 Apr 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.
shule xie, doctor contact
jinsong li, doctor study director
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin, Tislelizumab and Polymeric Micellar Paclitaxel in people with Head and Neck Squamous Cell Carcinoma and Head and Neck Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 2 inclusion and 9 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: opening soon, as of the sponsor's last update on 16 Apr 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?
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 jinsong li, doctor (008618583879908, caobleat@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response (MPR) rate of metastatic lymph nodes (time frame: 10days after surgery). 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 16 Apr 2024.