Locally Advanced Rectal CancerPhase 2NCT05245474

Neoadjuvant Long-course Chemoradiation Plus PD-1 Blockade for Mid-low Locally Advanced Rectal Cancer

A Phase 2 study testing Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor) in people with Locally Advanced Rectal Cancer, run by Beijing Friendship Hospital at 8 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

This is a phase II/III, multi-center, open-label, 3-arm, randomized controlled trial assessing the efficacy and safety of neoadjuvant long-course chemoradiation combined with Tislelizumab (PD-1 inhibitor) and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Locally Advanced Rectal Cancer
What is being tested?: Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 186 participants
Where: 8 sitesChina
Study dates: 1 Apr 2022to 1 Sep 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

aged 18~75
ECOG score 0~2
biopsy diagnosed rectal adenocarcinoma, distal margin within 10cm to anal verge
no distant metastasis, staged II/III (T4b excluded) by MRI
maximum diameter of rectal cancer lesion≥10mm according to baseline CT or MRI (i.e. a "measurable lesion" as per RECIST 1.1 criteria)
willing and able to comply with study protocol

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consent to the use of blood and tissue specimens for study
no history of previous anti-tumor treatment (e.g. radiation, chemo, immuno, bio, herbal, etc.)
no disorders/diseases of immune system (e.g. systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, hyperthyroidism/hypothyroidism, ulcerative colitis, autoimmune hemolytic anemia, HIV infection, etc.)
no significant dysfunction of major viscera (e.g. heart, lung, liver, kidney, etc.)
no jaundice or gastrointestinal obstruction
no acute/ongoing infection
no significant irregularities in blood routine test and biochemical test results, particular requirements include: neutrophils≥1.5×109/L, HGB≥80g/L, platelet≥100×109/L, serum creatinine≤1.5×ULN, total bilirubin≤1.5×ULN, ALT、AST≤2.5×ULN
no social or mental disorder
for women of child-bearing age, a negative result of serological pregnancy test is required, and effective contraception measures from inclusion till 60 days after the last dose of study drug is required

Who cannot join

multiple cancers, or with concomitant malignant tumors besides rectal cancer
having received any anti-cancer treatment (surgery, drugs, etc.) in the past 5 years
history of recent major surgery
with condition that affects the absorption of capecitabine via gastrointestinal tract (e.g. inability to swallow, nausea, vomiting, chronic diarrhea, etc.)
with uncontrolled, severe, concomitant diseases of any sort
allergic to any of the ingredients under study

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estimated survival ≤ 5 years due to any reason
preparing for or having previously received organ or bone marrow transplant
having received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to inclusion
for patients with history of disorder of central nervous system, investigator discretion is required as to whether the clinical severity prevents the signing of informed consent or affects the patient's oral medication compliance
with other conditions/issues that may affect the study results or cause the study treatment to be terminated halfway (e.g. alcoholism, drug abuse, etc.)
pregnant or lactating women, or women intending on conception during treatment period

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhongtao Zhang, M.D. contact

+8613801060364

zhangzht@ccmu.edu.cn

City, postcode or hospital

Sites recruiting now only

8 sites in 1 country

China8 sites, 4 recruiting

Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Kai Pang, M.D., 86 18811792819, pk2wys@foxmail.com
Zhongtao Zhang, M.D.
Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Completed
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality
Completed
Beijing Hospital
Beijing, Beijing Municipality
Completed
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Danyang Zhu, M.D., 86 13466711222, 17710202092@163.com
Yi Xiao, M.D.
Recruiting
Peking University First Hospital
Beijing, Beijing Municipality
Yingchao Wu, M.D., 86 13693214551, wuyingchao112@163.com
Xin Wang, M.D.
Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Shuang Cao, M.D., 1610301226@pku.edu.cn
Yingjiang Ye, M.D.
Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality
Completed

Other trials in China

About this study

Official title: Efficacy and Safety of Neoadjuvant Long-course Chemoradiation Plus Tislelizumab in Mid-low Locally Advanced Rectal Cancer: a Phase II, Multi-center, Open-label, Randomized Controlled Trial (POLARSTAR Trial)

Read the detailed description

This phase II, multi-center, open-label, 3-arm, randomized trial aims to recruit patients aged 18-75 years, diagnosed histologically as rectal adenocarcinoma, without metastasis (by CT), staged II/III (by MRI, T4b excluded), with distal margin within 10cm to anal verge. All patients should have no history of immune diseases, nor history of immunotherapy or radiotherapy. Sample size was thoroughly calculated to be 186. Eligible participants will be randomly assigned to Experiment Arm 1 (50.4Gy radiation, capecitabine, and anti-PD1 starting at Day 8 of radiation), Experiment Arm 2 (50.4Gy radiation, capecitabine, and anti-PD1 starting 2 weeks after completion of radiation), and Control Arm (50.4Gy radiation, capecitabine) in a 1:1:1 ratio. Randomization is stratified by different centers, with a block size of 6. For both experiment arms, Tislelizumab (anti-PD1) is scheduled to be administered at 200mg each time for 3 times, with 3-week intervals. The primary endpoint is pCR rate, and secondary endpoints include sphincter-preserving rate, adverse event rates, and DFS and OS rate at 2, 3 and 5 years post-operation. Data will be analyzed with an intention-to-treat or modified intention-to-treat approach.

Conditions: Locally Advanced Rectal Cancer
Being tested: Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)
Keywords: LARC, radiation, chemoradiation, PD-1, Tislelizumab, neoadjuvant, randomized, controlled

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)Combination product
Tislelizumab is added to long-course chemoradiation (CRT) of LARC patients, with CRT+concurrent Tislelizumab for Arm 1, CRT+sequential Tislelizumab for Arm 2, and CRT only for Arm 3

Study groups in NCT05245474
Study group	Role	What they receive
CRT+concurrent PD-1 inhibition (Experiment Arm 1)	Experimental	Long-course chemoradiation plus PD-1 inhibition (Tislelizumab 200mg, 3 times, 3-week interval) starting on Day 8 of radiation therapy. TME surgery is scheduled in 8~12 weeks after completion of radiation. Receives: Combination Product: Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)
CRT+sequential PD-1 inhibition (Experiment Arm 2)	Experimental	Long-course chemoradiation plus PD-1 inhibition (Tislelizumab 200mg, 3 times, 3-week interval) starting on Day 15 after completion of radiation therapy. TME surgery is scheduled in 8~12 weeks after completion of radiation. Receives: Combination Product: Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)
CRT without PD-1 inhibition (Control Arm)	Active comparator	Long-course chemoradiation plus PD-1 inhibition with no PD-1 inhibition. TME surgery is scheduled in 6~12 weeks after completion of radiation. Receives: Combination Product: Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)

What is being measured

The primary outcome is the main question the study is designed to answer.

pCR rate
pathological complete response rate
Measured: within 10 days after surgery

Secondary outcomes (21)

NAR score
neoadjuvant rectal score
Measured: within 10 days after surgery
2-y OS rate
2-year overall survival rate
Measured: 2 year
2-y DFS rate
2-year disease free survival rate
Measured: 2 year
3-y OS rate
3-year overall survival rate
Measured: 3 year
3-y DFS rate
3-year disease free survival rate
Measured: 3 year
5-y OS rate
5-year overall survival rate
Measured: 5 year
5-y DFS rate
5-year disease free survival rate
Measured: 5 year
median OS time
median length (in months) of overall survival period
Measured: 0~60 months
median DFS time
median length (in months) of disease free survival period
Measured: 0~60 months
R0 resection rate
rate of R0 resection
Measured: within 10 days after surgery
sphincter preserving rate
proportion of patients with preserved anal sphincter
Measured: instantly after surgery
nearly pCR rate
nearly pathological complete response rate
Measured: within 10 days after surgery
ORR
objective response rate
Measured: before surgery
immune-related adverse event rate
adverse event rate that is deemed to be associated with PD-1 inhibition
Measured: from commencing of PD-1 inhibition to the 30th day after surgery
Grade 3+ immune-related adverse event rate
adverse event (above Grade 3) rate that is deemed to be associated with PD-1 inhibition
Measured: from commencing of PD-1 inhibition to the 30th day after surgery
treatment-related adverse event rate
adverse event rate that is deemed to be associated with all treatments
Measured: from commencing of treatment to the 30th day after surgery
Grade 3+ treatment-related adverse event rate
adverse event (above Grade 3) rate that is deemed to be associated with all treatments
Measured: from commencing of treatment to the 30th day after surgery
cCR rate
clinical complete response rate
Measured: before surgery
incidence rate of surgical complications
incidence rate of surgical complications within 30 days after surgery
Measured: within 30 days after surgery
incidence rate of Grade 3+ surgical complications
incidence rate of Grade 3+ surgical complications within 30 days after surgery
Measured: within 30 days after surgery
quality of life score
quality of life score during the 5 years after surgery, multiple timepoint assessment
Measured: during the 5 years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20221 Sep 2029

First posted18 Feb 2022
Study start1 Apr 2022
Primary completion1 Mar 2024 (estimated)
Study completion1 Sep 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Locally Advanced Rectal CancerStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 186 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05245474
Sponsor's protocol ID: BFH-POLARSTAR
Status last verified: Jan 2024
First submitted: 6 Feb 2022
Last updated: 10 Jan 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Export of individual patient data is a sensitive issue according to current Chinese laws

Publications

Pang K, Yang Y, Zhao P, Wu G, Li J, Gao J, Yao H, Yang Y, Zhang Z. Adding immune checkpoint blockade to neoadjuvant chemoradiation in locally advanced rectal cancer. Br J Surg. 2022 Oct 14;109(11):1178-1179. doi: 10.1093/bjs/znac298. No abstract available.
PubMed 36001602
Pang K, Sun P, Liu X, Yang D, Zhao P, Huang Y, Cao S, Gao Y, Chen G, Yu H, Duan L, Yang Y, Zhang Z. Development of the rationale of a personalized cancer vaccine based on the in situ vaccine effect of radiotherapy: a mechanistic study of the POLARSTAR trial. Cancer Immunol Immunother. 2025 Nov 12;74(12):369. doi: 10.1007/s00262-025-04229-3.
PubMed 41222702
Yang Y, Pang K, Lin G, Liu X, Gao J, Zhou J, Xu L, Gao Z, Wu Y, Li A, Han J, Wu G, Wang X, Li F, Ye Y, Zhang J, Chen G, Wang H, Kong Y, Wu A, Xiao Y, Yao H, Zhang Z. Neoadjuvant chemoradiation with or without PD-1 blockade in locally advanced rectal cancer: a randomized phase 2 trial. Nat Med. 2025 Feb;31(2):449-456. doi: 10.1038/s41591-024-03360-5. Epub 2025 Jan 6.
PubMed 39762418
Pang K, Yang Y, Tian D, Zeng N, Cao S, Ling S, Gao J, Zhao P, Wang H, Kong Y, Zhang J, Chen G, Deng W, Bai Z, Jin L, Wu G, Zhu D, Wang Y, Zhou J, Wu B, Lin G, Xiao Y, Gao Z, Ye Y, Wang X, Li A, Han J, Yao H, Yang Y, Zhang Z. Long-course chemoradiation plus concurrent/sequential PD-1 blockade as neoadjuvant treatment for MMR-status-unscreened locally advanced rectal cancer: protocol of a multicentre, phase 2, randomised controlled trial (the POLAR-STAR trial). BMJ Open. 2023 Sep 12;13(9):e069499. doi: 10.1136/bmjopen-2022-069499.
PubMed 37699634

Interested in taking part?

Zhongtao Zhang, M.D.

+8613801060364

zhangzht@ccmu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Combining DCSZ11 With Radiation and Chemotherapy as Neoadjuvant Treatment for pMMR Locally Advanced Rectal Cancer
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All Locally Advanced Rectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Neoadjuvant Long-course Chemoradiation Plus Tislelizumab in Mid-low Locally Advanced Rectal Cancer: a Phase II, Multi-center, Open-label, Randomized Controlled Trial (POLARSTAR Trial)
ClinicalTrials.gov ID: NCT05245474
Acronym / sponsor ID: BFH-POLARSTAR
Conditions: Locally Advanced Rectal Cancer
Keywords: LARC, radiation, chemoradiation, PD-1, Tislelizumab, neoadjuvant, randomized, controlled
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 186 participants (estimated)
Lead sponsor: Beijing Friendship HospitalUniversity, hospital or other
Collaborators: Beijing Chao Yang Hospital, Xuanwu Hospital, Beijing, Beijing Hospital, Peking Union Medical College Hospital, Peking University First Hospital, Peking University People's Hospital, Peking University Cancer Hospital & Institute, BeiGene
Study start: 1 Apr 2022 (actual)
Primary completion: 1 Mar 2024 (estimated)
Study completion: 1 Sep 2029 (estimated)
First posted: 18 Feb 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
CRT+concurrent PD-1 inhibition (Experiment Arm 1)	Experimental	Combination Product: Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)Long-course chemoradiation plus PD-1 inhibition (Tislelizumab 200mg, 3 times, 3-week interval) starting on Day 8 of radiation therapy. TME surgery is scheduled in 8~12 weeks after completion of radiation.
CRT+sequential PD-1 inhibition (Experiment Arm 2)	Experimental	Combination Product: Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)Long-course chemoradiation plus PD-1 inhibition (Tislelizumab 200mg, 3 times, 3-week interval) starting on Day 15 after completion of radiation therapy. TME surgery is scheduled in 8~12 weeks after completion of radiation.
CRT without PD-1 inhibition (Control Arm)	Active comparator	Combination Product: Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)Long-course chemoradiation plus PD-1 inhibition with no PD-1 inhibition. TME surgery is scheduled in 6~12 weeks after completion of radiation.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

aged 18~75
ECOG score 0~2
biopsy diagnosed rectal adenocarcinoma, distal margin within 10cm to anal verge
no distant metastasis, staged II/III (T4b excluded) by MRI
maximum diameter of rectal cancer lesion≥10mm according to baseline CT or MRI (i.e. a "measurable lesion" as per RECIST 1.1 criteria)

Key exclusion criteria (12 listed)

multiple cancers, or with concomitant malignant tumors besides rectal cancer
having received any anti-cancer treatment (surgery, drugs, etc.) in the past 5 years
history of recent major surgery
with condition that affects the absorption of capecitabine via gastrointestinal tract (e.g. inability to swallow, nausea, vomiting, chronic diarrhea, etc.)
with uncontrolled, severe, concomitant diseases of any sort

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
Long-course chemoradiation, with or without Tislelizumab (PD-1 inhibitor)Tislelizumab is added to long-course chemoradiation (CRT) of LARC patients, with CRT+concurrent Tislelizumab for Arm 1, CRT+sequential Tislelizumab for Arm 2, and CRT only for Arm 3	Combination product	CRT without PD-1 inhibition (Control Arm), CRT+concurrent PD-1 inhibition (Experiment Arm 1), CRT+sequential PD-1 inhibition (Experiment Arm 2)

Primary outcome

pCR rate
Time frame: within 10 days after surgery
pathological complete response rate

21 secondary outcomes

NAR score
Time frame: within 10 days after surgery
2-y OS rate
Time frame: 2 year
2-y DFS rate
Time frame: 2 year
3-y OS rate
Time frame: 3 year
3-y DFS rate
Time frame: 3 year
5-y OS rate
Time frame: 5 year
5-y DFS rate
Time frame: 5 year
median OS time
Time frame: 0~60 months
median DFS time
Time frame: 0~60 months
R0 resection rate
Time frame: within 10 days after surgery
sphincter preserving rate
Time frame: instantly after surgery
nearly pCR rate
Time frame: within 10 days after surgery
ORR
Time frame: before surgery
immune-related adverse event rate
Time frame: from commencing of PD-1 inhibition to the 30th day after surgery
Grade 3+ immune-related adverse event rate
Time frame: from commencing of PD-1 inhibition to the 30th day after surgery
treatment-related adverse event rate
Time frame: from commencing of treatment to the 30th day after surgery
Grade 3+ treatment-related adverse event rate
Time frame: from commencing of treatment to the 30th day after surgery
cCR rate
Time frame: before surgery
incidence rate of surgical complications
Time frame: within 30 days after surgery
incidence rate of Grade 3+ surgical complications
Time frame: within 30 days after surgery
quality of life score
Time frame: during the 5 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 10 Jan 2024.
Background: PubMed 36001602Pang K, Yang Y, Zhao P, Wu G, Li J, Gao J, Yao H, Yang Y, Zhang Z. Adding immune checkpoint blockade to neoadjuvant chemoradiation in locally advanced rectal cancer. Br J Surg. 2022 Oct 14;109(11):1178-1179. doi: 10.1093/bjs/znac298. No abstract available.
Derived from this study: PubMed 41222702Pang K, Sun P, Liu X, Yang D, Zhao P, Huang Y, Cao S, Gao Y, Chen G, Yu H, Duan L, Yang Y, Zhang Z. Development of the rationale of a personalized cancer vaccine based on the in situ vaccine effect of radiotherapy: a mechanistic study of the POLARSTAR trial. Cancer Immunol Immunother. 2025 Nov 12;74(12):369. doi: 10.1007/s00262-025-04229-3.
Derived from this study: PubMed 39762418Yang Y, Pang K, Lin G, Liu X, Gao J, Zhou J, Xu L, Gao Z, Wu Y, Li A, Han J, Wu G, Wang X, Li F, Ye Y, Zhang J, Chen G, Wang H, Kong Y, Wu A, Xiao Y, Yao H, Zhang Z. Neoadjuvant chemoradiation with or without PD-1 blockade in locally advanced rectal cancer: a randomized phase 2 trial. Nat Med. 2025 Feb;31(2):449-456. doi: 10.1038/s41591-024-03360-5. Epub 2025 Jan 6.
Derived from this study: PubMed 37699634Pang K, Yang Y, Tian D, Zeng N, Cao S, Ling S, Gao J, Zhao P, Wang H, Kong Y, Zhang J, Chen G, Deng W, Bai Z, Jin L, Wu G, Zhu D, Wang Y, Zhou J, Wu B, Lin G, Xiao Y, Gao Z, Ye Y, Wang X, Li A, Han J, Yao H, Yang Y, Zhang Z. Long-course chemoradiation plus concurrent/sequential PD-1 blockade as neoadjuvant treatment for MMR-status-unscreened locally advanced rectal cancer: protocol of a multicentre, phase 2, randomised controlled trial (the POLAR-STAR trial). BMJ Open. 2023 Sep 12;13(9):e069499. doi: 10.1136/bmjopen-2022-069499.
Study protocol was published as an abstract on 2022 ESMO CongressLink provided by the sponsor.
Individual participant dataSharing planned: No. Export of individual patient data is a sensitive issue according to current Chinese laws

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RecruitingPhase 1
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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.

Zhongtao Zhang, M.D. contact

+8613801060364

zhangzht@ccmu.edu.cn

Zhongtao Zhang principal investigator

Beijing Friendship Hospital

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 15 inclusion and 12 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 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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 Zhongtao Zhang, M.D. (+8613801060364, zhangzht@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pCR rate (time frame: within 10 days after surgery). 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 NCT05245474, which also lists 4 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 Jan 2024.