Locally Advanced Rectal CancerPhase 2NCT05086627
Short-course Radiotherapy Followed by Tislelizumab + CapeOX in the Treatment for Locally Advanced Rectal Cancer
A Phase 2 study testing Tislelizumab, Short-course radiotherapy and Capecitabine+Oxaliplatin in people with Locally Advanced Rectal Cancer, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
This study is a single-center, prospective, open-label, randomized controlled clinical study, and the purpose of this study was to compare the pathological complete response rate (PCR) of patients with locally advanced rectal cancer treated with short-course radiotherapy sequential Tislelizumab combined with CapeOX… 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?
- Tislelizumab, Short-course radiotherapy and Capecitabine+Oxaliplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 20 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients or their family members agree to participate in the study and sign the informed consent form;
- Patients ≥ 18 and ≤75 years old, male or female;
- ECOG performance status of 0 or 1;
- Patients with histologically confirmed rectal adenocarcinoma;
- The clinical diagnosis of chest CT, abdominal and pelvic enhanced MRI was T1-2N+M0 and cT3-4NanyM0 (the T and N stage was based on pelvic enhanced MRI+DWI, M stage was determined by liver enhanced MRI+DWI and chest CT, and if necessary, PET-CT was used);
- The distance between the lower edge of the tumor and the anal edge is less than or equal to 10 cm;
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- No history of immune system diseases;
- No history of immunodeficiency, including HIV positive;
- No history of other malignancies;
- No history of myocarditis;
- No history of severe cardiovascular and cerebrovascular diseases;
- No history of thyroid dysfunction;
- No history of liver and kidney diseases;
- No history of mental illness, no history of Infectious diseases;
- No history of organ transplantation or allogeneic bone marrow transplantation;
- There is no history of other systemic diseases other than the above diseases;
- Voluntarily accept the neoadjuvant treatment scheme of radiotherapy, sequential chemotherapy / chemotherapy combined with immunotherapy;
- Swallowing pills normally;
- Rectal cancer without radiotherapy, chemotherapy, surgery, Chinese medicine anti-tumor treatment, etc.;
- Surgical treatment is planned after neoadjuvant treatment.
Who cannot join
- Patients who do not meet the above inclusion criteria;
- Documented history of allergy to study drugs, including any component of Tislelizumab, capecitabine, oxaliplatin and other platinum drugs;
- Patients who need to be treated with corticosteroid (dose equivalent to prednisone of >10 mg/day) or other immunosuppressive agents within 2 weeks prior to study drug administration; Major surgery or severe trauma within 4 weeks before the first use of the study drug;
- Severe infection (CTCAE > 2) occurred within 4 weeks before the first use of the study drug; Baseline chest imaging revealed active pulmonary inflammation, signs and symptoms of infection within 14 days prior to the first use of the study drug, or oral or intravenous antibiotic therapy, except for prophylactic use of antibiotics;
- Female patients who is pregnant or breastfeeding;
- Patients who refuse to sign informed consent by themselves or their authorized persons;
- Patients with poor cognitive ability, unable to answer questions, unable to fill in questionnaires or mental disorders;
- Patients considered unsuitable for the study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
About this study
Official title: A Single -Centers, Randomized, Open-label, Controlled Phase Ⅱ Clinical Trial of Short-course Radiotherapy Followed by Tislelizumab + CapeOX in the Treatment for Locally Advanced Rectal Cancer
This study is a single-center, prospective, open-label, randomized controlled clinical study, and the purpose of this study was to compare the pathological complete response rate (PCR) of patients with locally advanced rectal cancer treated with short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A) versus short-course radiotherapy sequential CapeOX (group B). A total of 100 patients with locally advanced rectal cancer will be enrolled in the study. These patients were randomly assigned to the experimental group (group A) and the control group (group B) in a ratio of 1:1.
Read the detailed description
Baseline examnation: All enrolled patients in this study, in addition to routine laboratory and imaging examinations such as blood routine, blood biochemistry, serum tumor markers (Incl. CEA, CA-199, CA-724 β2-microglobulin, Ferroprotein), chest CT, abdominal and pelvic MRI, etc., were required to undergo KRAS, NRAS, BREF, PD-L1, MMR/MSS testings before SCRT, and blood lymphocyte subgroups were analyzed before SCRT, systemic therapy, and surgery.
Subjects in group A will be treated according to the following treatment plan:
Standard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5)
Sequential treatment period: After resting for 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14) and an additional intravenous infusion of 200mg Tislelizumab on the first day of each cycle of CapeOX.
Surgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed.
Postoperative adjuvant chemotherapy:Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX with or without Tislelizumab will be undergone to these willing cases.
Subjects in group B will be treated according to the following treatment plan:
Standard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5)
Sequential treatment period: After resting for 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14).
Surgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed.
Postoperative adjuvant chemotherapy:Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX will be undergone to these willing cases.
Endpoint: The primary endpoint was pCR rate. Secondary endpoints included MPR (TRG0+TRG1), 3-year PFS, 3-year OS, and treatment safety.
Follow-up records during treatment: For the duration of operation, the time required to complete the TME surgery and the amount of blood loss were recorded, and the impact of neoadjuvant therapy on the operation was observed. During the SCRT process, and the period of resting after SCRT, of the entire preoperative systemic treatment, of the resting after TME surgery, of the postoperative chemotherapy (these willing cases), the occurrence of adverse events (AE) of participants were closely monitored and actively responded.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Tislelizumab, Short-course radiotherapy, Capecitabine+Oxaliplatin
- Keywords
- Locally advanced rectal cancer, Neoadjuvant radiotherapy, Immune checkpoint inhibitors, Programmed death-1 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Patients were treated with Tislelizumab on the first day of each cycle of CapeOX (Capecitabine+Oxaliplatin).
Short-course radiotherapyRadiation
Patients were treated with short-course neoadjuvant radiotherapy
Capecitabine+OxaliplatinDrug
Patients were treated with neoadjuvant chemotherapy with CapeOX (Capecitabine+Oxaliplatin).
| Study group | Role | What they receive |
|---|---|---|
| Short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A) | Experimental | Standard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5)
Sequential treatment period: After resting for 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14) and an additional intravenous infusion of 200mg Tislelizumab on the first day of each cycle of CapeOX.
Surgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed.
Postoperative adjuvant chemotherapy: Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX with or without Tislelizumab will be undergone to these willing cases. Receives: Drug: Tislelizumab; Radiation: Short-course radiotherapy; Drug: Capecitabine+Oxaliplatin |
| Short-course radiotherapy sequential CapeOX (group B) | Active comparator | Standard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5)
Sequential treatment period: After resting for 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14).
Surgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed.
Postoperative adjuvant chemotherapy: Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX will be undergone to these willing cases. Receives: Radiation: Short-course radiotherapy; Drug: Capecitabine+Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate
Pathological complete response rate was defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes (ypT0N0)
Measured: 1 week after surgery
Secondary outcomes (4)
major pathologic response (TRG0+TRG1)
TRG 0 indicates no remaining viable cancer cells (complete response); TRG 1 indicates a single cell or small groups of cancer cells (moderate response)
Measured: 1 week after surgery
3-year PFS
PFS refers to the time from randomization to tumor progresses or death from any cause
Measured: 3 years from randomization
3-year OS
OS refers to the time from randomization to death from any cause
Measured: 3 years from randomization
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] during treatment, including chemoradiotherapy, immunology, sugery
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Sep 2021
- Primary completion30 Jul 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth 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
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086627
- Sponsor's protocol ID
- 2021104
- Status last verified
- Aug 2024
- First submitted
- 15 Sep 2021
- Last updated
- 22 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu F, Hu X, Li B, Zhang J, Wang G, Fan H, An G, Yu B, Ma H, Zhao B, Li Z, Gao B, Liu M, Wang X, Liu D, Hu J, Liu H, Liu Y, Wang F, Zhang J, Feng J, Wang X, Meng Z, Zhang Z, Li Z, Sun J, Liu S, Wang N, Han J, Niu W, Zhou C, Xiao L, Wang G. Short-Course Radiotherapy-Based Total Neoadjuvant Therapy plus Tislelizumab for Locally Advanced Rectal Cancer (Neo-STAR): Early Outcomes of a Randomized Phase II Trial. Cancer Commun (Lond). 2026 Jul 23;46:0041. doi: 10.34133/cancomm.0041. eCollection 2026.
PubMed 42495710
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single -Centers, Randomized, Open-label, Controlled Phase Ⅱ Clinical Trial of Short-course Radiotherapy Followed by Tislelizumab + CapeOX in the Treatment for Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT05086627
- Acronym / sponsor ID
- 2021104
- Conditions
- Locally Advanced Rectal Cancer
- Keywords
- Locally advanced rectal cancer, Neoadjuvant radiotherapy, Immune checkpoint inhibitors, Programmed death-1 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single-center, prospective, open-label, randomized controlled clinical study, and the purpose of this study was to compare the pathological complete response rate (PCR) of patients with locally advanced rectal cancer treated with short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A) versus short-course radiotherapy sequential CapeOX (group B). A total of 100 patients with locally advanced rectal cancer will be enrolled in the study. These patients were randomly assigned to the experimental group (group A) and the control group (group B) in a ratio of 1:1.
Detailed description
Baseline examnation: All enrolled patients in this study, in addition to routine laboratory and imaging examinations such as blood routine, blood biochemistry, serum tumor markers (Incl. CEA, CA-199, CA-724 β2-microglobulin, Ferroprotein), chest CT, abdominal and pelvic MRI, etc., were required to undergo KRAS, NRAS, BREF, PD-L1, MMR/MSS testings before SCRT, and blood lymphocyte subgroups were analyzed before SCRT, systemic therapy, and surgery.
Subjects in group A will be treated according to the following treatment plan:
Standard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5)
Sequential treatment period: After resting for 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14) and an additional intravenous infusion of 200mg Tislelizumab on the first day of each cycle of CapeOX.
Surgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed.
Postoperative adjuvant chemotherapy:Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX with or without Tislelizumab will be undergone to these willing cases.
Subjects in group B will be treated according to the following treatment plan:
Standard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5)
Sequential treatment period: After resting for 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14).
Surgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed.
Postoperative adjuvant chemotherapy:Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX will be undergone to these willing cases.
Endpoint: The primary endpoint was pCR rate. Secondary endpoints included MPR (TRG0+TRG1), 3-year PFS, 3-year OS, and treatment safety.
Follow-up records during treatment: For the duration of operation, the time required to complete the TME surgery and the amount of blood loss were recorded, and the impact of neoadjuvant therapy on the operation was observed. During the SCRT process, and the period of resting after SCRT, of the entire preoperative systemic treatment, of the resting after TME surgery, of the postoperative chemotherapy (these willing cases), the occurrence of adverse events (AE) of participants were closely monitored and actively responded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A) | Experimental | Drug: Tislelizumab, Radiation: Short-course radiotherapy, Drug: Capecitabine+OxaliplatinStandard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5) Sequential treatment period: After resting for 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14) and an additional intravenous infusion of 200mg Tislelizumab on the first day of each cycle of CapeOX. Surgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed. Postoperative adjuvant chemotherapy: Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX with or without Tislelizumab will be undergone to these willing cases. |
| Short-course radiotherapy sequential CapeOX (group B) | Active comparator | Radiation: Short-course radiotherapy, Drug: Capecitabine+OxaliplatinStandard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5) Sequential treatment period: After resting for 3-7 days following completion of SCRT, patients were treated with 4 cycles of CapeOX (Oxaliplatin 130 mg/m2 intravenously, day 1; Capecitabine 1000 mg/m2, Bid,days 1-14). Surgery: After 3 weeks of the completion of neoadjuvant therapy, the TME surgery was performed. Postoperative adjuvant chemotherapy: Whether postoperative chemotherapy was implemented mainly depended on the patient's wishes, and 2 cycles of CapeOX will be undergone to these willing cases. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients or their family members agree to participate in the study and sign the informed consent form;
- Patients ≥ 18 and ≤75 years old, male or female;
- ECOG performance status of 0 or 1;
- Patients with histologically confirmed rectal adenocarcinoma;
- The clinical diagnosis of chest CT, abdominal and pelvic enhanced MRI was T1-2N+M0 and cT3-4NanyM0 (the T and N stage was based on pelvic enhanced MRI+DWI, M stage was determined by liver enhanced MRI+DWI and chest CT, and if necessary, PET-CT was used);
Key exclusion criteria (8 listed)
- Patients who do not meet the above inclusion criteria;
- Documented history of allergy to study drugs, including any component of Tislelizumab, capecitabine, oxaliplatin and other platinum drugs;
- Patients who need to be treated with corticosteroid (dose equivalent to prednisone of >10 mg/day) or other immunosuppressive agents within 2 weeks prior to study drug administration; Major surgery or severe trauma within 4 weeks before the first use of the study drug;
- Severe infection (CTCAE > 2) occurred within 4 weeks before the first use of the study drug; Baseline chest imaging revealed active pulmonary inflammation, signs and symptoms of infection within 14 days prior to the first use of the study drug, or oral or intravenous antibiotic therapy, except for prophylactic use of antibiotics;
- Female patients who is pregnant or breastfeeding;
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 |
|---|---|---|
| TislelizumabPatients were treated with Tislelizumab on the first day of each cycle of CapeOX (Capecitabine+Oxaliplatin). | Drug | Short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A) |
| Short-course radiotherapyPatients were treated with short-course neoadjuvant radiotherapy | Radiation | Short-course radiotherapy sequential CapeOX (group B), Short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A) |
| Capecitabine+OxaliplatinPatients were treated with neoadjuvant chemotherapy with CapeOX (Capecitabine+Oxaliplatin). | Drug | Short-course radiotherapy sequential CapeOX (group B), Short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A) |
Primary outcome
Pathological complete response rate
Time frame: 1 week after surgery
Pathological complete response rate was defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes (ypT0N0)
4 secondary outcomes
major pathologic response (TRG0+TRG1)
Time frame: 1 week after surgery
3-year PFS
Time frame: 3 years from randomization
3-year OS
Time frame: 3 years from randomization
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Derived from this study: PubMed 42495710Wu F, Hu X, Li B, Zhang J, Wang G, Fan H, An G, Yu B, Ma H, Zhao B, Li Z, Gao B, Liu M, Wang X, Liu D, Hu J, Liu H, Liu Y, Wang F, Zhang J, Feng J, Wang X, Meng Z, Zhang Z, Li Z, Sun J, Liu S, Wang N, Han J, Niu W, Zhou C, Xiao L, Wang G. Short-Course Radiotherapy-Based Total Neoadjuvant Therapy plus Tislelizumab for Locally Advanced Rectal Cancer (Neo-STAR): Early Outcomes of a Randomized Phase II Trial. Cancer Commun (Lond). 2026 Jul 23;46:0041. doi: 10.34133/cancomm.0041. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Tislelizumab, Short-course radiotherapy and Capecitabine+Oxaliplatin in people with Locally Advanced Rectal Cancer, run by Hebei Medical University Fourth 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 20 inclusion and 8 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: finished, as of the sponsor's last update on 22 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (time frame: 1 week 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 NCT05086627, which also lists 1 linked publication.
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 22 Aug 2024.