Oral Squamous Cell Carcinoma (OSCC)Phase 2NCT07812467
Rimegepant-Sensitized Neoadjuvant Chemoimmunotherapy for Oral or Oropharyngeal Squamous Cell Carcinoma
A Phase 2 study testing Rimegepant, Tislelizumab and Nab-paclitaxel in people with Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal Squamous Cell Carcinoma (OPSCC), run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study will evaluate whether adding rimegepant to standard neoadjuvant chemoimmunotherapy can improve treatment response in patients with primary or recurrent oral or oropharyngeal squamous cell carcinoma who are planned to undergo surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oral Squamous Cell Carcinoma (OSCC), Oropharyngeal Squamous Cell Carcinoma (OPSCC)
- What is being tested?
- Rimegepant, Tislelizumab and Nab-paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 31 Oct 2033
- 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
- Age 18 to 75 years, regardless of sex.
- Histologically or cytologically confirmed oral or oropharyngeal squamous cell carcinoma, including primary disease or recurrent disease after previous treatment that is considered amenable to repeat curative-intent resection.
- Planned to receive neoadjuvant chemoimmunotherapy followed by surgery after multidisciplinary evaluation.
- At least one evaluable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate major organ function.
- Voluntary participation and provision of written informed consent.
Who cannot join
- Severe cardiac, hepatic, or renal dysfunction.
- Active autoimmune disease.
- Pregnancy or breastfeeding.
- Known allergy or hypersensitivity to rimegepant or any component of the planned neoadjuvant treatment.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
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
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Yu Zhang, +86-13818927554, zhang.yu4@zs-hospital.sh.cn
About this study
Official title: A Phase II Randomized Controlled Clinical Trial of Rimegepant-Sensitized Neoadjuvant Chemoimmunotherapy in Patients With Oral/Oropharyngeal Squamous Cell Carcinoma
This study will evaluate whether adding rimegepant to standard neoadjuvant chemoimmunotherapy can improve treatment response in patients with primary or recurrent oral or oropharyngeal squamous cell carcinoma who are planned to undergo surgery.
Rimegepant blocks the receptor for calcitonin gene-related peptide, also known as CGRP. CGRP signaling may affect the tumor immune environment and the response of tumors to anticancer treatment.
Read more
The study includes an initial safety run-in stage involving 20 participants, followed by a randomized controlled stage involving 200 participants. During the randomized stage, participants will be assigned in a 1:1 ratio to receive standard neoadjuvant chemoimmunotherapy either with or without rimegepant. All participants will receive two cycles of neoadjuvant treatment followed by definitive or intended curative surgery.
The main outcome is the major pathological response rate, defined as 10% or less residual viable tumor in the surgical specimen. Other outcomes include pathological complete response, objective response, event-free survival, overall survival, changes in pain and quality of life, and treatment safety.
- Being tested
- Rimegepant, Tislelizumab, Nab-paclitaxel, Cisplatin
- Keywords
- Rimegepant, Neoadjuvant Chemoimmunotherapy, CGRP Receptor Antagonist, Calcitonin Gene-Related Peptide, Major Pathological Response, Tislelizumab, Nab-Paclitaxel, Cisplatin
- 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.
RimegepantDrug
Rimegepant 75 mg will be administered orally every other day from the initiation until the completion of neoadjuvant chemoimmunotherapy.
TislelizumabDrug
Tislelizumab 200 mg will be administered by intravenous infusion on Day 1 of each 3-week treatment cycle for two cycles.
Nab-paclitaxelDrug
Nab-paclitaxel 260 mg/m² will be administered by intravenous infusion on Day 2 of each 3-week treatment cycle for two cycles.
CisplatinDrug
A total dose of cisplatin 75 mg/m² will be administered intravenously over Days 2 and 3 of each 3-week treatment cycle for two cycles.
| Study group | Role | What they receive |
|---|---|---|
| Safety Run-In Combination Arm | Experimental | Twenty participants will receive rimegepant plus standard neoadjuvant chemoimmunotherapy for two 3-week cycles, followed by definitive or intended curative surgery. Safety and tolerability will be evaluated before initiation of the randomized stage. Receives: Drug: Rimegepant; Drug: Tislelizumab; Drug: Nab-paclitaxel; Drug: Cisplatin |
| Randomized Combination Arm | Experimental | Participants randomized to this arm will receive rimegepant plus standard neoadjuvant chemoimmunotherapy for two 3-week cycles, followed by definitive or intended curative surgery. Receives: Drug: Rimegepant; Drug: Tislelizumab; Drug: Nab-paclitaxel; Drug: Cisplatin |
| Randomized Control Arm | Active comparator | Participants randomized to this arm will receive standard neoadjuvant chemoimmunotherapy alone for two 3-week cycles, followed by definitive or intended curative surgery. Receives: Drug: Tislelizumab; Drug: Nab-paclitaxel; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response Rate
Percentage of participants with 10% or less residual viable tumor cells in the resected primary or recurrent tumor specimen after neoadjuvant treatment. For the randomized efficacy analysis, participants who do not undergo surgery or whose surgical specimens are not evaluable for pathological response will be considered not to have achieved major pathological response. Results will also be reported separately for participants with primary and recurrent disease.
Measured: At pathological assessment of the definitive surgical specimen after completion of two 3-week cycles of neoadjuvant treatment
Secondary outcomes (7)
Pathological Complete Response Rate
Percentage of participants with no residual viable tumor cells in the resected primary or recurrent tumor specimen after neoadjuvant treatment, using the same pathological assessment scope as that used for major pathological response. Participants who do not undergo surgery or whose surgical specimens are not evaluable for pathological response will be considered not to have achieved pathological complete response in the randomized efficacy analysis.
Measured: At pathological assessment of the definitive surgical specimen after completion of two 3-week cycles of neoadjuvant treatment
Objective Response Rate
Percentage of participants with a complete response or partial response according to Response Evaluation Criteria in Solid Tumors version 1.1.
Measured: From baseline to preoperative radiographic assessment after completion of two 3-week cycles of neoadjuvant treatment
Event-Free Survival
Event-free survival is defined as the time from randomization to the first occurrence of any of the following: disease progression during neoadjuvant treatment that precludes the planned definitive or intended curative surgery; locoregional recurrence or progression after surgery; distant metastasis or distant disease progression; or death from any cause. Participants without an event will be censored at the date of the last assessment confirming that they remained event-free.
Measured: From randomization to the first event or censoring, assessed up to 5 years
Overall Survival
Overall survival is defined as the time from randomization to death from any cause. Participants who are alive at the time of analysis will be censored at the date they were last known to be alive.
Measured: From randomization until death or censoring, assessed up to 5 years
Change From Baseline in Pain Score
Change from baseline in pain severity as assessed using the McGill Pain Questionnaire. Changes in pain scores will be compared between treatment groups at protocol-specified assessment time points.
Measured: At baseline, at the end of each neoadjuvant treatment cycle, and at the preoperative assessment
Change From Baseline in Quality of Life
Change from baseline in quality-of-life scores assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30.
Measured: At baseline, at the end of each neoadjuvant treatment cycle, and at the preoperative assessment
Incidence of Treatment-Emergent Adverse Events
Incidence, type, and severity of treatment-emergent adverse events and serious adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Measured: From signing informed consent through 90 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oral Squamous Cell Carcinoma (OSCC)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of an initial open-label safety run-in stage followed by an open-label randomized parallel-group stage. The safety run-in stage will enroll 20 participants who will receive rimegepant plus standard neoadjuvant chemoimmunotherapy. After the prespecified safety criteria are met, 200 participants will be randomized in a 1:1 ratio to receive rimegepant plus standard neoadjuvant chemoimmunotherapy or standard neoadjuvant chemoimmunotherapy alone. Stratified block randomization will be used in the randomized stage.
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812467
- Sponsor's protocol ID
- B2026-377R
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not currently planned to be shared. The study involves sensitive clinical, pathological, and human genetic resource data. Any future sharing of de-identified participant-level data would require additional institutional ethics review, compliance with applicable Chinese regulations on human genetic resources and data security, and appropriate data use agreements. The registry record will be updated if the sharing plan changes.
Publications
Zhang Y, Guo Y, Liu Z, Sun Y, Yang X, Chen M, Feng G, Lin C, Wang Y, Zhang Z, Zhu Y, Ye J, Liu J, Shi J, Zhou X, Han Q, Liu Y, Jiang Q, Yu Y, Wang X, Zhang C, Sun Y, Zhou J, Fan J, Ji T. Cancer cells co-opt an inter-organ neuroimmune circuit to escape immune surveillance. Cell. 2025 Nov 26;188(24):6754-6773.e29. doi: 10.1016/j.cell.2025.09.029. Epub 2025 Oct 24.
PubMed 41138728Zhang Y, Lin C, Liu Z, Sun Y, Chen M, Guo Y, Liu W, Zhang C, Chen W, Sun J, Xia R, Hu Y, Yang X, Li J, Zhang Z, Cao W, Sun S, Wang X, Ji T. Cancer cells co-opt nociceptive nerves to thrive in nutrient-poor environments and upon nutrient-starvation therapies. Cell Metab. 2022 Dec 6;34(12):1999-2017.e10. doi: 10.1016/j.cmet.2022.10.012. Epub 2022 Nov 16.
PubMed 36395769Balood M, Ahmadi M, Eichwald T, Ahmadi A, Majdoubi A, Roversi K, Roversi K, Lucido CT, Restaino AC, Huang S, Ji L, Huang KC, Semerena E, Thomas SC, Trevino AE, Merrison H, Parrin A, Doyle B, Vermeer DW, Spanos WC, Williamson CS, Seehus CR, Foster SL, Dai H, Shu CJ, Rangachari M, Thibodeau J, V Del Rincon S, Drapkin R, Rafei M, Ghasemlou N, Vermeer PD, Woolf CJ, Talbot S. Nociceptor neurons affect cancer immunosurveillance. Nature. 2022 Nov;611(7935):405-412. doi: 10.1038/s41586-022-05374-w. Epub 2022 Nov 2.
PubMed 36323780
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Controlled Clinical Trial of Rimegepant-Sensitized Neoadjuvant Chemoimmunotherapy in Patients With Oral/Oropharyngeal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07812467
- Acronym / sponsor ID
- B2026-377R
- Keywords
- Rimegepant, Neoadjuvant Chemoimmunotherapy, CGRP Receptor Antagonist, Calcitonin Gene-Related Peptide, Major Pathological Response, Tislelizumab, Nab-Paclitaxel, Cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2033 (estimated)
- First posted
- 10 Sep 2026 (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 will evaluate whether adding rimegepant to standard neoadjuvant chemoimmunotherapy can improve treatment response in patients with primary or recurrent oral or oropharyngeal squamous cell carcinoma who are planned to undergo surgery.
Rimegepant blocks the receptor for calcitonin gene-related peptide, also known as CGRP. CGRP signaling may affect the tumor immune environment and the response of tumors to anticancer treatment.
The study includes an initial safety run-in stage involving 20 participants, followed by a randomized controlled stage involving 200 participants. During the randomized stage, participants will be assigned in a 1:1 ratio to receive standard neoadjuvant chemoimmunotherapy either with or without rimegepant. All participants will receive two cycles of neoadjuvant treatment followed by definitive or intended curative surgery.
The main outcome is the major pathological response rate, defined as 10% or less residual viable tumor in the surgical specimen. Other outcomes include pathological complete response, objective response, event-free survival, overall survival, changes in pain and quality of life, and treatment safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study consists of an initial open-label safety run-in stage followed by an open-label randomized parallel-group stage. The safety run-in stage will enroll 20 participants who will receive rimegepant plus standard neoadjuvant chemoimmunotherapy. After the prespecified safety criteria are met, 200 participants will be randomized in a 1:1 ratio to receive rimegepant plus standard neoadjuvant chemoimmunotherapy or standard neoadjuvant chemoimmunotherapy alone. Stratified block randomization will be used in the randomized stage.
| Arm | Type | Receives |
|---|---|---|
| Safety Run-In Combination Arm | Experimental | Drug: Rimegepant, Drug: Tislelizumab, Drug: Nab-paclitaxel, Drug: CisplatinTwenty participants will receive rimegepant plus standard neoadjuvant chemoimmunotherapy for two 3-week cycles, followed by definitive or intended curative surgery. Safety and tolerability will be evaluated before initiation of the randomized stage. |
| Randomized Combination Arm | Experimental | Drug: Rimegepant, Drug: Tislelizumab, Drug: Nab-paclitaxel, Drug: CisplatinParticipants randomized to this arm will receive rimegepant plus standard neoadjuvant chemoimmunotherapy for two 3-week cycles, followed by definitive or intended curative surgery. |
| Randomized Control Arm | Active comparator | Drug: Tislelizumab, Drug: Nab-paclitaxel, Drug: CisplatinParticipants randomized to this arm will receive standard neoadjuvant chemoimmunotherapy alone for two 3-week cycles, followed by definitive or intended curative surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 75 years, regardless of sex.
- Histologically or cytologically confirmed oral or oropharyngeal squamous cell carcinoma, including primary disease or recurrent disease after previous treatment that is considered amenable to repeat curative-intent resection.
- Planned to receive neoadjuvant chemoimmunotherapy followed by surgery after multidisciplinary evaluation.
- At least one evaluable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
Key exclusion criteria (5 listed)
- Severe cardiac, hepatic, or renal dysfunction.
- Active autoimmune disease.
- Pregnancy or breastfeeding.
- Known allergy or hypersensitivity to rimegepant or any component of the planned neoadjuvant treatment.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
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 |
|---|---|---|
| RimegepantRimegepant 75 mg will be administered orally every other day from the initiation until the completion of neoadjuvant chemoimmunotherapy. | Drug | Randomized Combination Arm, Safety Run-In Combination Arm |
| TislelizumabTislelizumab 200 mg will be administered by intravenous infusion on Day 1 of each 3-week treatment cycle for two cycles. | Drug | Randomized Combination Arm, Randomized Control Arm, Safety Run-In Combination Arm |
| Nab-paclitaxelNab-paclitaxel 260 mg/m² will be administered by intravenous infusion on Day 2 of each 3-week treatment cycle for two cycles. | Drug | Randomized Combination Arm, Randomized Control Arm, Safety Run-In Combination Arm |
| CisplatinA total dose of cisplatin 75 mg/m² will be administered intravenously over Days 2 and 3 of each 3-week treatment cycle for two cycles. | Drug | Randomized Combination Arm, Randomized Control Arm, Safety Run-In Combination Arm |
Primary outcome
Major Pathological Response Rate
Time frame: At pathological assessment of the definitive surgical specimen after completion of two 3-week cycles of neoadjuvant treatment
Percentage of participants with 10% or less residual viable tumor cells in the resected primary or recurrent tumor specimen after neoadjuvant treatment. For the randomized efficacy analysis, participants who do not undergo surgery or whose surgical specimens are not evaluable for pathological response will be considered not to have achieved major pathological response. Results will also be reported separately for participants with primary and recurrent disease.
7 secondary outcomes
Pathological Complete Response Rate
Time frame: At pathological assessment of the definitive surgical specimen after completion of two 3-week cycles of neoadjuvant treatment
Objective Response Rate
Time frame: From baseline to preoperative radiographic assessment after completion of two 3-week cycles of neoadjuvant treatment
Event-Free Survival
Time frame: From randomization to the first event or censoring, assessed up to 5 years
Overall Survival
Time frame: From randomization until death or censoring, assessed up to 5 years
Change From Baseline in Pain Score
Time frame: At baseline, at the end of each neoadjuvant treatment cycle, and at the preoperative assessment
Change From Baseline in Quality of Life
Time frame: At baseline, at the end of each neoadjuvant treatment cycle, and at the preoperative assessment
Incidence of Treatment-Emergent Adverse Events
Time frame: From signing informed consent through 90 days after the last dose of study 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 10 Sep 2026.
- Background: PubMed 41138728Zhang Y, Guo Y, Liu Z, Sun Y, Yang X, Chen M, Feng G, Lin C, Wang Y, Zhang Z, Zhu Y, Ye J, Liu J, Shi J, Zhou X, Han Q, Liu Y, Jiang Q, Yu Y, Wang X, Zhang C, Sun Y, Zhou J, Fan J, Ji T. Cancer cells co-opt an inter-organ neuroimmune circuit to escape immune surveillance. Cell. 2025 Nov 26;188(24):6754-6773.e29. doi: 10.1016/j.cell.2025.09.029. Epub 2025 Oct 24.
- Background: PubMed 36395769Zhang Y, Lin C, Liu Z, Sun Y, Chen M, Guo Y, Liu W, Zhang C, Chen W, Sun J, Xia R, Hu Y, Yang X, Li J, Zhang Z, Cao W, Sun S, Wang X, Ji T. Cancer cells co-opt nociceptive nerves to thrive in nutrient-poor environments and upon nutrient-starvation therapies. Cell Metab. 2022 Dec 6;34(12):1999-2017.e10. doi: 10.1016/j.cmet.2022.10.012. Epub 2022 Nov 16.
- Background: PubMed 36323780Balood M, Ahmadi M, Eichwald T, Ahmadi A, Majdoubi A, Roversi K, Roversi K, Lucido CT, Restaino AC, Huang S, Ji L, Huang KC, Semerena E, Thomas SC, Trevino AE, Merrison H, Parrin A, Doyle B, Vermeer DW, Spanos WC, Williamson CS, Seehus CR, Foster SL, Dai H, Shu CJ, Rangachari M, Thibodeau J, V Del Rincon S, Drapkin R, Rafei M, Ghasemlou N, Vermeer PD, Woolf CJ, Talbot S. Nociceptor neurons affect cancer immunosurveillance. Nature. 2022 Nov;611(7935):405-412. doi: 10.1038/s41586-022-05374-w. Epub 2022 Nov 2.
- Individual participant dataSharing planned: No. Individual participant data are not currently planned to be shared. The study involves sensitive clinical, pathological, and human genetic resource data. Any future sharing of de-identified participant-level data would require additional institutional ethics review, compliance with applicable Chinese regulations on human genetic resources and data security, and appropriate data use agreements. The registry record will be updated if the sharing plan changes.
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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 Rimegepant, Tislelizumab and Nab-paclitaxel in people with Oral Squamous Cell Carcinoma (OSCC) and Oropharyngeal Squamous Cell Carcinoma (OPSCC), run by Shanghai Zhongshan 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 7 inclusion and 5 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 10 Sep 2026. 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 Yu Zhang (+86-13818927554, zhang.yu4@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response Rate (time frame: At pathological assessment of the definitive surgical specimen after completion of two 3-week cycles of neoadjuvant treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07812467, which also lists 3 linked publications.
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 10 Sep 2026.