ESCCPhase 2NeoSCRTIC-01NCT07808853
Node-Sparing Short-Course Radiotherapy (25 Gy/5 Fractions) Combined With Chemoimmunotherapy as Neoadjuvant Treatment for Locally Advanced Esophageal Squamous Cell Carcinoma：A Prospective Single-Arm, Phase II Study
A Phase 2 study testing Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/Carboplatin in people with ESCC, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
This prospective, single-arm phase II study will evaluate the efficacy and safety of lymphatic-drainage-sparing short-course radiotherapy combined with camrelizumab and nab-paclitaxel/carboplatin as neoadjuvant treatment for patients with resectable, locally advanced thoracic esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ESCC
- What is being tested?
- Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/Carboplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2026to 31 Dec 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
- Written informed consent before enrollment.
- Age 18 to 75 years, any sex.
- Treatment-naive esophageal squamous cell carcinoma confirmed by pathology and PET-CT.
- Clinical stage cT1b-3N1-2M0 or cT2-3N0M0 (stage II/III according to the AJCC 9th edition).
- Disease assessed as amenable to R0 surgical resection before treatment.
- At least one measurable lesion according to RECIST v1.1.
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- ECOG performance status 0-1.
- Adequate organ function: absolute neutrophil count ≥1,500/mm³; platelets ≥100,000/mm³; hemoglobin ≥9 g/dL; serum creatinine ≤1.5 mg/dL and/or creatinine clearance ≥60 mL/min; bilirubin ≤1.5×ULN; AST and ALT ≤1.5×ULN; no blood components or hematopoietic growth factors within 14 days.
- For women of childbearing potential: medically accepted contraception during treatment and for 3 months afterward; negative serum or urine HCG within 7 days before enrollment; not breastfeeding.
- For men who are not surgically sterile: agreement to use medically accepted contraception with their partner during treatment and for 3 months afterward.
- Willingness to participate and comply with safety and survival follow-up.
Who cannot join
- Prior radiotherapy, chemotherapy, prolonged/high-dose corticosteroid therapy, surgery, or molecular targeted therapy.
- Previous or concurrent other malignancy.
- Prior PD-1/PD-L1 therapy; known allergy to macromolecular protein preparations or any component of PD-1 therapy.
- Active autoimmune disease or relevant autoimmune disease history as specified in the protocol.
- Immunosuppressive agents for immunosuppression within 2 weeks before enrollment.
- Symptomatic pleural or peritoneal effusion requiring therapeutic puncture or drainage.
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- Poorly controlled clinically significant cardiac disease as specified in the protocol.
- Abnormal coagulation with bleeding tendency or thrombolytic/anticoagulant therapy.
- Recent gastrointestinal conditions associated with bleeding or perforation risk.
- Severe bleeding within 3 months, hemoptysis within 4 weeks, or thromboembolic event within 12 months according to protocol thresholds.
- Active infection or unexplained fever >38.5°C during screening or before first dose.
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks before study treatment.
- History/current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severe pulmonary dysfunction.
- Congenital/acquired immunodeficiency including HIV infection, or active hepatitis outside protocol-defined limits.
- Participation in another clinical study or completion of a previous clinical study within 1 month; anticipated need for other systemic anticancer therapy.
- Live vaccine within 4 weeks before study treatment or anticipated during the study.
- Known history of psychotropic drug abuse, alcohol abuse, or illicit drug abuse.
- Unable or unwilling to bear self-paid portions of study-related examinations or treatment.
- Any other condition considered by the investigator to compromise participant safety, study completion, or data/sample collection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hongying Liao MD, Professor / Chief Physician, MD and PhD contact
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Guanzhou, Guangdong, 510655
Hongying Liao MD, Professor / Chief Physician, MD and PhD, +86-020-35919121, liaohy2@mail.sysu.edu.cn
Jiayan Wu MD, MD and PhD, +86-020-35919121, wujy526@mail.sysu.edu.cn
About this study
This prospective, single-arm phase II study will evaluate the efficacy and safety of lymphatic-drainage-sparing short-course radiotherapy combined with camrelizumab and nab-paclitaxel/carboplatin as neoadjuvant treatment for patients with resectable, locally advanced thoracic esophageal squamous cell carcinoma. Participants will receive three 3-week cycles of camrelizumab plus chemotherapy, with 25 Gy in 5 fractions of short-course radiotherapy delivered to the primary tumor and radiographically positive lymph nodes while elective lymphatic drainage regions are spared. Definitive McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant therapy. The primary endpoint is pathologic complete response (ypT0N0).
Read the detailed description
The study is designed as a Simon optimal two-stage, single-arm phase II trial. The target sample size is 33 participants, allowing for approximately 10% attrition. In stage 1, 15 participants will be enrolled; if at least 4 achieve pathologic complete response, enrollment will proceed to stage 2. A further 15 evaluable participants will then be enrolled. The protocol considers the regimen promising if at least 15 of 30 evaluable participants achieve pathologic complete response.
Eligible participants are treatment-naive adults aged 18-75 years with PET-CT and pathologically confirmed thoracic esophageal squamous cell carcinoma, clinical stage cT1b-3N1-2M0 or cT2-3N0M0 (AJCC 9th edition), ECOG performance status 0-1, measurable disease by RECIST v1.1, and disease considered amenable to R0 resection.
Neoadjuvant treatment consists of camrelizumab 200 mg intravenously on Day 1 every 3 weeks plus nab-paclitaxel 260 mg/m² on Day 1 and carboplatin AUC 5 on Day 1 for three cycles. Short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle, targeting only the primary tumor and positive lymph nodes and sparing elective lymphatic drainage regions. Tumor imaging is performed after the second cycle and before surgery. McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant therapy when hematologic and organ function have recovered. Postoperative survival follow-up is planned every 3 months for 3 years.
- Conditions
- ESCC
- Being tested
- Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/Carboplatin
- Keywords
- ESCC; short-course radiotherapy; lymphatic drainage sparing;neoadjuvant therapy; pCR
- Medical subject headings
- Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/CarboplatinRadiation
Participants receive three 3-week cycles of camrelizumab plus nab-paclitaxel and carboplatin. Lymphatic-drainage-sparing short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle. McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant treatment.
Drug: Camrelizumab Camrelizumab 200 mg intravenously on Day 1 of each 3-week cycle for 3 cycles.
Drug: Nab-paclitaxel Nab-paclitaxel 260 mg/m² intravenously on Day 1 of each 3-week cycle for 3 cycles.
Drug: Carboplatin Carboplatin AUC 5 intravenously on Day 1 of each 3-week cycle for 3 cycles.
Radiation: Short-course radiotherapy 25 Gy in 5 fractions over 5 days, delivered to the primary tumor and radiographically positive lymph nodes while elective lymphatic drainage regions are spared.
Procedure: McKeown esophagectomy McKeown esophagectomy with thoracoabdominal two-field lymph node dissection, planned 4-6 weeks after completion of neoadjuvant therapy (maximum extension of 2 additional
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/Carboplatin | Experimental | Participants receive three 3-week cycles of camrelizumab plus nab-paclitaxel and carboplatin. Lymphatic-drainage-sparing short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle. McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant treatment. Receives: Radiation: Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR) Rate
Percentage of participants undergoing definitive surgery who have no residual viable tumor in the resected primary tumor and regional lymph nodes, defined in the protocol as ypT0N0.
Measured: At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
Secondary outcomes (5)
Major Pathologic Response (MPR) Rate
Major pathologic response (MPR) is defined as ≤10% residual viable tumor cells in the primary esophageal tumor resection specimen, regardless of lymph node status, as pre-specified in study protocol. The percentage of participants achieving this protocol-defined MPR criterion in post-neoadjuvant surgical resection specimen will be calculated.
Measured: At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
Objective Response Rate (ORR)
Percentage of participants with complete response or partial response according to RECIST v1.1 based on protocol-specified imaging assessments.
Measured: From baseline to the preoperative tumor assessment, approximately 9-15 weeks after initiation of neoadjuvant therapy.
R0 Resection Rate
Percentage of participants undergoing esophagectomy with microscopically negative resection margins.
Measured: Upon completion of final postoperative pathological assessment, expected within 7 days post-operatively
Disease-Free Survival (DFS) Rate
Disease-free survival rate at 1 and 3 years.
Measured: 1 year and 3 years after surgery.
Overall Survival (OS) Rate
Overall survival rate at the specified time points. Survival will be estimated using the Kaplan-Meier method.
Measured: 1 year and 3 years after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ESCCStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, 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
- Model description
- All enrolled participants receive the same neoadjuvant regimen followed by planned McKeown esophagectomy. A Simon optimal two-stage design is used for the primary pCR endpoint.
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HONGYING_LIAO, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808853
- Sponsor's protocol ID
- 2026ZSLYEC-647
- Acronym
- NeoSCRTIC-01
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data sharing is not currently planned. De-identified data may be considered upon reasonable request and subject to institutional and ethics requirements.
Publications
van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.
PubMed 22646630Pennathur A, Gibson MK, Jobe BA, Luketich JD. Oesophageal carcinoma. Lancet. 2013 Feb 2;381(9864):400-12. doi: 10.1016/S0140-6736(12)60643-6.
PubMed 23374478
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Node-Sparing Short-Course Radiotherapy (25 Gy/5 Fractions) Combined With Chemoimmunotherapy as Neoadjuvant Treatment for Locally Advanced Esophageal Squamous Cell Carcinoma：A Prospective Single-Arm, Phase II Study
- ClinicalTrials.gov ID
- NCT07808853
- Acronym / sponsor ID
- NeoSCRTIC-01 / 2026ZSLYEC-647
- Conditions
- ESCC
- Keywords
- ESCC; short-course radiotherapy; lymphatic drainage sparing;neoadjuvant therapy; pCR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 9 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 prospective, single-arm phase II study will evaluate the efficacy and safety of lymphatic-drainage-sparing short-course radiotherapy combined with camrelizumab and nab-paclitaxel/carboplatin as neoadjuvant treatment for patients with resectable, locally advanced thoracic esophageal squamous cell carcinoma. Participants will receive three 3-week cycles of camrelizumab plus chemotherapy, with 25 Gy in 5 fractions of short-course radiotherapy delivered to the primary tumor and radiographically positive lymph nodes while elective lymphatic drainage regions are spared. Definitive McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant therapy. The primary endpoint is pathologic complete response (ypT0N0).
Detailed description
The study is designed as a Simon optimal two-stage, single-arm phase II trial. The target sample size is 33 participants, allowing for approximately 10% attrition. In stage 1, 15 participants will be enrolled; if at least 4 achieve pathologic complete response, enrollment will proceed to stage 2. A further 15 evaluable participants will then be enrolled. The protocol considers the regimen promising if at least 15 of 30 evaluable participants achieve pathologic complete response.
Eligible participants are treatment-naive adults aged 18-75 years with PET-CT and pathologically confirmed thoracic esophageal squamous cell carcinoma, clinical stage cT1b-3N1-2M0 or cT2-3N0M0 (AJCC 9th edition), ECOG performance status 0-1, measurable disease by RECIST v1.1, and disease considered amenable to R0 resection.
Neoadjuvant treatment consists of camrelizumab 200 mg intravenously on Day 1 every 3 weeks plus nab-paclitaxel 260 mg/m² on Day 1 and carboplatin AUC 5 on Day 1 for three cycles. Short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle, targeting only the primary tumor and positive lymph nodes and sparing elective lymphatic drainage regions. Tumor imaging is performed after the second cycle and before surgery. McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant therapy when hematologic and organ function have recovered. Postoperative survival follow-up is planned every 3 months for 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants receive the same neoadjuvant regimen followed by planned McKeown esophagectomy. A Simon optimal two-stage design is used for the primary pCR endpoint.
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/Carboplatin | Experimental | Radiation: Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/CarboplatinParticipants receive three 3-week cycles of camrelizumab plus nab-paclitaxel and carboplatin. Lymphatic-drainage-sparing short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle. McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent before enrollment.
- Age 18 to 75 years, any sex.
- Treatment-naive esophageal squamous cell carcinoma confirmed by pathology and PET-CT.
- Clinical stage cT1b-3N1-2M0 or cT2-3N0M0 (stage II/III according to the AJCC 9th edition).
- Disease assessed as amenable to R0 surgical resection before treatment.
Key exclusion criteria (19 listed)
- Prior radiotherapy, chemotherapy, prolonged/high-dose corticosteroid therapy, surgery, or molecular targeted therapy.
- Previous or concurrent other malignancy.
- Prior PD-1/PD-L1 therapy; known allergy to macromolecular protein preparations or any component of PD-1 therapy.
- Active autoimmune disease or relevant autoimmune disease history as specified in the protocol.
- Immunosuppressive agents for immunosuppression within 2 weeks before 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 |
|---|---|---|
| Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/CarboplatinParticipants receive three 3-week cycles of camrelizumab plus nab-paclitaxel and carboplatin. Lymphatic-drainage-sparing short-course radiotherapy (25 Gy in 5 fractions over 5 days) is delivered after the first cycle. McKeown esophagectomy is planned 4-6 weeks after completion of neoadjuvant treatment. Drug: Camrelizumab Camrelizumab 200 mg intravenously on Day 1 of each 3-week cycle for 3 cycles. Drug: Nab-paclitaxel Nab-paclitaxel 260 mg/m² intravenously on Day 1 of each 3-week cycle for 3 cycles. Drug: Carboplatin Carboplatin AUC 5 intravenously on Day 1 of each 3-week cycle for 3 cycles. Radiation: Short-course radiotherapy 25 Gy in 5 fractions over 5 days, delivered to the primary tumor and radiographically positive lymph nodes while elective lymphatic drainage regions are spared. Procedure: McKeown esophagectomy McKeown esophagectomy with thoracoabdominal two-field lymph node dissection, planned 4-6 weeks after completion of neoadjuvant therapy (maximum extension of 2 additional | Radiation | Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/Carboplatin |
Primary outcome
Pathologic Complete Response (pCR) Rate
Time frame: At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
Percentage of participants undergoing definitive surgery who have no residual viable tumor in the resected primary tumor and regional lymph nodes, defined in the protocol as ypT0N0.
5 secondary outcomes
Major Pathologic Response (MPR) Rate
Time frame: At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.
Objective Response Rate (ORR)
Time frame: From baseline to the preoperative tumor assessment, approximately 9-15 weeks after initiation of neoadjuvant therapy.
R0 Resection Rate
Time frame: Upon completion of final postoperative pathological assessment, expected within 7 days post-operatively
Disease-Free Survival (DFS) Rate
Time frame: 1 year and 3 years after surgery.
Overall Survival (OS) Rate
Time frame: 1 year and 3 years after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 22646630van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.
- Background: PubMed 23374478Pennathur A, Gibson MK, Jobe BA, Luketich JD. Oesophageal carcinoma. Lancet. 2013 Feb 2;381(9864):400-12. doi: 10.1016/S0140-6736(12)60643-6.
- Simon's Two-Stage designLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Individual participant data sharing is not currently planned. De-identified data may be considered upon reasonable request and subject to institutional and ethics requirements.
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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.
Hongying Liao MD, Professor / Chief Physician, MD and PhD contact
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 Neoadjuvant SCRT + Camrelizumab + Nab-Paclitaxel/Carboplatin in people with ESCC, run by Sixth Affiliated Hospital, Sun Yat-sen University 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 11 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: looking for participants now, as of the sponsor's last update on 9 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 Hongying Liao MD, Professor / Chief Physician, MD and PhD (+86-020-35919121, liaohy2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (pCR) Rate (time frame: At definitive surgery, approximately 4-8 weeks after completion of neoadjuvant therapy.). 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 NCT07808853, which also lists 2 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 9 Sep 2026.