Rectal CancerPhase 2PKUCH- R11NCT07394192
Short-Course Radiotherapy With Tumor-Draining Lymph Node Preservation Followed by PD-1 Inhibitors in pMMR/MSS Stage II-III Rectal Cancer
A Phase 2 study testing short-course radiotherapy that preserves tumor-draining lymph nodes in people with Rectal Cancer and Radiotherapy, run by Peking University Cancer Hospital & Institute.
Trial summary
This study aims to evaluate the efficacy (pathological complete response rate) of short-course radiotherapy with preservation of tumor-draining lymph nodes followed by sequential PD-1 inhibitor neoadjuvant therapy in patients with stage II-III pMMR/MSS locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer, Radiotherapy, PD-1 Inhibitor
- What is being tested?
- short-course radiotherapy that preserves tumor-draining lymph nodes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 31 Dec 2031
- 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 18-75 years old, regardless of sex.
- Fibrocolonoscopy or digital rectal examination indicates that the distal border of the lesion is located 5-10 cm from the anal verge.
- Pathologically confirmed rectal adenocarcinoma.
- Imaging examinations (including pelvic MRI and chest-abdominal CT) confirm a clinical stage of II/III (cT3-T4aN0 or cT2-4aN+, MRF (-), with no distant metastasis) according to the AJCC Cancer Staging Manual, 8th Edition (2018) (for detailed TNM staging of rectal cancer).
- If N+, metastatic lymph nodes are confined to the mesorectal and superior rectal artery drainage regions, with no lateral pelvic lymph node metastasis.
- ⑥ Confirmed by immunohistochemistry or molecular testing to be mismatch repair proficient (pMMR) or microsatellite stable (MSS).
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- ⑦ Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1 (see Appendix 2 for details).
- ⑧ Meeting the following laboratory criteria: Hemoglobin ≥ 90 g/L, white blood cell count ≥ 3.5 × 10⁹/L; Neutrophil count ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L; Creatinine ≤ 1.0 × upper limit of normal (ULN), blood urea nitrogen (BUN) ≤ 1.0 × ULN; Alanine aminotransferase (ALT) ≤ 1.5 × ULN; Aspartate aminotransferase (AST) ≤ 1.5 × ULN; Alkaline phosphatase (ALP) ≤ 1.5 × ULN; Total bilirubin (TBIL) ≤ 1.5 × ULN; Urine protein negative; normal coagulation time; normal thyroid function.
- ⑨ Patients with primary rectal cancer must have undergone no surgical interventions (excluding palliative stoma formation), chemotherapy, or other antitumor treatments from the time of diagnosis to enrollment.
- ⑩ The planned radiation field must have no history of prior radiotherapy.
- The patient voluntarily agrees to participate in this study, signs the informed consent form, demonstrates good compliance, and is willing to cooperate with follow-up visits and data provision.
Who cannot join
- Previous treatment with anti-PD-1/L1, anti-CTLA-4 immunotherapies, or other investigational immunotherapeutic agents is excluded.
- Patients with severe autoimmune diseases are excluded, including active inflammatory bowel disease (such as Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's granulomatosis), etc.
- Patients with symptomatic interstitial lung disease or active infectious/non-infectious pneumonitis are excluded.
- Patients with clinical or imaging evidence of intestinal obstruction or perforation, or those deemed by the investigator to be at high risk of perforation or hemorrhage, are excluded.
- History of other malignancies, excluding curatively treated non-melanoma skin cancer and carcinoma in situ of the cervix, are excluded.
- Patients with severe cardiovascular or cerebrovascular diseases are excluded, including cerebrovascular accidents, transient ischemic attacks, myocardial infarction within 6 months prior to enrollment, or significant vascular diseases (including but not limited to aortic aneurysms requiring surgical repair or recent arterial thrombosis). Also excluded are those with poorly controlled cardiac symptoms or conditions, such as unstable angina, heart failure of New York Heart Association (NYHA) Class II or higher, left ventricular ejection fraction (LVEF) < 50% on echocardiography, or severe arrhythmias uncontrolled by medication.
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- Physical examination findings, clinical laboratory abnormalities, or other uncontrolled conditions that, in the investigator's judgment, may interfere with the study results or increase the patient's risk of treatment complications are excluded.
- Lactating or pregnant women are excluded. ⑨ Patients with congenital or acquired immunodeficiency diseases, including human immunodeficiency virus (HIV) infection, or a history of organ transplantation or allogeneic stem cell transplantation, are excluded.
- ⑩ Known active hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, or active tuberculosis are excluded.
- ⑪ Patients with concurrent use of other immunomodulators, chemotherapeutic agents, other investigational drugs, or requiring long-term corticosteroid therapy are excluded.
- ⑫ Patients with psychiatric disorders, substance abuse, or social issues that may affect compliance, as determined upon physician review, are excluded.
- ⑬ Patients with allergies or contraindications to the investigational drug(s) are excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Exploratory Study on the Efficacy and Safety of Short-Course Radiotherapy With Tumor-Draining Lymph Node Preservation Followed by PD-1 Inhibitors in pMMR/MSS Stage II-III Rectal Cancer
This study aims to evaluate the efficacy (pathological complete response rate) of short-course radiotherapy with preservation of tumor-draining lymph nodes followed by sequential PD-1 inhibitor neoadjuvant therapy in patients with stage II-III pMMR/MSS locally advanced rectal cancer.
Read the detailed description
This study is a single-arm, open-label exploratory clinical trial designed to investigate the feasibility and preliminary efficacy of a novel neoadjuvant treatment strategy for locally advanced rectal cancer. The strategy combines short-course radiotherapy (SCRT) with deliberate preservation of tumor-draining lymph nodes, followed by sequential PD-1 inhibitor therapy, with the aim of enhancing antitumor immune activation prior to definitive surgery. Given the exploratory nature of the study, no blinding will be applied, and both investigators and participants will be aware of the assigned treatment. Approximately 44 eligible patients are planned for enrollment.
The study is conducted across four sequential phases: screening and enrollment, neoadjuvant treatment, surgical intervention, and postoperative follow-up. During the screening phase, eligibility will be confirmed through histopathological evaluation, molecular testing, and standardized imaging assessments to establish disease stage and anatomical suitability for the protocol-defined treatment approach.
Neoadjuvant treatment begins with short-course radiotherapy administered in the first week after enrollment. Radiotherapy will be delivered using volumetric modulated arc therapy (VMAT) following standard procedures for patient positioning, immobilization, CT/MRI simulation, target volume delineation, treatment planning, and image-guided verification. In contrast to conventional pelvic irradiation, the clinical target volume is intentionally limited to the primary rectal tumor, excluding tumor-draining lymph nodes and elective pelvic nodal regions, in order to preserve regional immune structures. The prescribed dose is 25 Gy delivered in five fractions over five consecutive working days. Patients will be closely monitored for acute radiation-related toxicities, which will be graded and managed according to standard criteria.
Two weeks after completion of radiotherapy, patients will initiate immunotherapy. Sintilimab, a PD-1 inhibitor, will be administered intravenously at a fixed dose of 200 mg every three weeks for four cycles. Prior to each cycle, patients will undergo routine safety evaluations, including physical examination and laboratory testing, to assess treatment tolerance and determine eligibility for continued dosing. Treatment interruption, delay, or discontinuation will be guided by protocol-defined toxicity management rules.
A comprehensive restaging assessment will be performed approximately 2-4 weeks after completion of neoadjuvant therapy using standardized imaging modalities, including pelvic MRI and thoracoabdominal CT. Patients without evidence of disease progression will proceed to definitive surgical management. Radical resection with total mesorectal excision (TME) is required, with the specific surgical procedure selected according to tumor characteristics and individual clinical considerations.
Postoperative management will be determined based on pathological findings and multidisciplinary team discussion approximately one month after surgery. All patients will then enter a structured follow-up program lasting three years, with visits scheduled every three months. Follow-up evaluations will focus on disease status, survival outcomes, and the assessment of late treatment-related toxicities, using clinical examinations, laboratory tests, tumor markers, and imaging studies as clinically indicated.
- Conditions
- Rectal Cancer, Radiotherapy, PD-1 Inhibitor
- Being tested
- short-course radiotherapy that preserves tumor-draining lymph nodes
- Keywords
- short-course radiotherapy, tumor-draining lymph nodes, PD-1 inhibitors, pMMR/MSS, locally advanced rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short-course radiotherapy that preserves tumor-draining lymph nodesRadiation
Patients with stage II-III pMMR/MSS locally advanced rectal cancer receive neoadjuvant therapy with short-course radiotherapy that preserves tumor-draining lymph nodes, followed by 4 cycles of PD-1 inhibitors
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Neoadjuvant therapy with short-course radiotherapy that preserves tumor-draining lymph nodes, followed by 4 cycles of PD-1 inhibitors Receives: Radiation: short-course radiotherapy that preserves tumor-draining lymph nodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response rate
Defined as the absence of residual tumor cells in the surgically resected specimen after neoadjuvant therapy, including both the primary site and lymph nodes.
Measured: Perioperative
Secondary outcomes (11)
tumor regression grade
The extent of postoperative tumor regression is graded and assessed according to the American Joint Committee on Cancer (AJCC) criteria, and the proportions of different grades are calculated.
Measured: Perioperative
R0 Resection Rate
R0 Resection Rate is defined as the proportion of patients in whom a complete microscopic resection is achieved. Specifically, it indicates that no residual tumor cells are found at the microscopic level on the surgical margin after pathological examination of the resected specimen, also known as a negative microscopic margin.
Measured: Perioperative
30-Day Postoperative Complication Rate
30-Day Postoperative Complication Rate is defined as the proportion of patients who experience one or more adverse events directly related to the surgical procedure within the first 30 days after the operation, with the severity of each complication classified according to the Clavien-Dindo Classification system.
Measured: within the first 30 days after the operation
3-Year Local-Regional Recurrence Rate
The cumulative incidence of disease recurrence confined to the primary tumor site (local) and/or the regional lymph node basins, assessed at 3 years following surgery. This rate is typically estimated using the Kaplan-Meier method.
Measured: 3 years following surgery
3-Year Distant Metastasis Rate
The cumulative incidence of cancer spread to distant organs or sites beyond the primary tumor region and its local lymphatic drainage area, assessed at 3 years following the surgery. This rate is typically estimated using the Kaplan-Meier method.
Measured: 3 years following the surgery
3-Year Disease-Free Survival (DFS) Rate
The proportion of patients who remain alive and free from any documented recurrence (local, regional, or distant), secondary primary cancer, or death from any cause, assessed at 3 years following surgery. The rate is estimated using the Kaplan-Meier method.
Measured: 3 years following surgery
3-Year Overall Survival (OS) Rate
The proportion of patients who are still alive from any cause, assessed at 3 years following surgery. This rate is estimated using the Kaplan-Meier method.
Measured: 3 years following surgery.
Toxicity Profile During Neoadjuvant Therapy (Graded by CTCAE v5.0)
The occurrence and severity of adverse events (toxicities) during the neoadjuvant treatment period will be documented and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
Measured: From the initiation of neoadjuvant therapy until 90 days after the last dose
EORTC QLQ-C30 questionnaire score
The impact of treatment on patients' quality of life (assessed using the EORTC QLQ-C30 questionnaires)
Measured: Baseline and very 3 months postoperatively until 3 years
EORTC QLQ-CR29 questionnaire score
The impact of treatment on patients' quality of life (assessed using the EORTC QLQ-CR29 questionnaires)
Measured: Baseline and very 3 months postoperatively until 3 years
the Low Anterior Resection Syndrome score
The impact of treatment on patients' anorectal function (evaluated with the Low Anterior Resection Syndrome score questionnaire)
Measured: Baseline and very 3 months postoperatively until 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394192
- Sponsor's protocol ID
- PKUCH- R11
- Acronym
- PKUCH- R11
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Efficacy and Safety of Short-Course Radiotherapy With Tumor-Draining Lymph Node Preservation Followed by PD-1 Inhibitors in pMMR/MSS Stage II-III Rectal Cancer
- ClinicalTrials.gov ID
- NCT07394192
- Acronym / sponsor ID
- PKUCH- R11 / PKUCH- R11
- Conditions
- Rectal Cancer, Radiotherapy, PD-1 Inhibitor
- Keywords
- short-course radiotherapy, tumor-draining lymph nodes, PD-1 inhibitors, pMMR/MSS, locally advanced rectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 6 Feb 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 aims to evaluate the efficacy (pathological complete response rate) of short-course radiotherapy with preservation of tumor-draining lymph nodes followed by sequential PD-1 inhibitor neoadjuvant therapy in patients with stage II-III pMMR/MSS locally advanced rectal cancer.
Detailed description
This study is a single-arm, open-label exploratory clinical trial designed to investigate the feasibility and preliminary efficacy of a novel neoadjuvant treatment strategy for locally advanced rectal cancer. The strategy combines short-course radiotherapy (SCRT) with deliberate preservation of tumor-draining lymph nodes, followed by sequential PD-1 inhibitor therapy, with the aim of enhancing antitumor immune activation prior to definitive surgery. Given the exploratory nature of the study, no blinding will be applied, and both investigators and participants will be aware of the assigned treatment. Approximately 44 eligible patients are planned for enrollment.
The study is conducted across four sequential phases: screening and enrollment, neoadjuvant treatment, surgical intervention, and postoperative follow-up. During the screening phase, eligibility will be confirmed through histopathological evaluation, molecular testing, and standardized imaging assessments to establish disease stage and anatomical suitability for the protocol-defined treatment approach.
Neoadjuvant treatment begins with short-course radiotherapy administered in the first week after enrollment. Radiotherapy will be delivered using volumetric modulated arc therapy (VMAT) following standard procedures for patient positioning, immobilization, CT/MRI simulation, target volume delineation, treatment planning, and image-guided verification. In contrast to conventional pelvic irradiation, the clinical target volume is intentionally limited to the primary rectal tumor, excluding tumor-draining lymph nodes and elective pelvic nodal regions, in order to preserve regional immune structures. The prescribed dose is 25 Gy delivered in five fractions over five consecutive working days. Patients will be closely monitored for acute radiation-related toxicities, which will be graded and managed according to standard criteria.
Two weeks after completion of radiotherapy, patients will initiate immunotherapy. Sintilimab, a PD-1 inhibitor, will be administered intravenously at a fixed dose of 200 mg every three weeks for four cycles. Prior to each cycle, patients will undergo routine safety evaluations, including physical examination and laboratory testing, to assess treatment tolerance and determine eligibility for continued dosing. Treatment interruption, delay, or discontinuation will be guided by protocol-defined toxicity management rules.
A comprehensive restaging assessment will be performed approximately 2-4 weeks after completion of neoadjuvant therapy using standardized imaging modalities, including pelvic MRI and thoracoabdominal CT. Patients without evidence of disease progression will proceed to definitive surgical management. Radical resection with total mesorectal excision (TME) is required, with the specific surgical procedure selected according to tumor characteristics and individual clinical considerations.
Postoperative management will be determined based on pathological findings and multidisciplinary team discussion approximately one month after surgery. All patients will then enter a structured follow-up program lasting three years, with visits scheduled every three months. Follow-up evaluations will focus on disease status, survival outcomes, and the assessment of late treatment-related toxicities, using clinical examinations, laboratory tests, tumor markers, and imaging studies as clinically indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Radiation: short-course radiotherapy that preserves tumor-draining lymph nodesNeoadjuvant therapy with short-course radiotherapy that preserves tumor-draining lymph nodes, followed by 4 cycles of PD-1 inhibitors |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-75 years old, regardless of sex.
- ⑥ Confirmed by immunohistochemistry or molecular testing to be mismatch repair proficient (pMMR) or microsatellite stable (MSS).
- ⑦ Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1 (see Appendix 2 for details).
- ⑧ Meeting the following laboratory criteria: Hemoglobin ≥ 90 g/L, white blood cell count ≥ 3.5 × 10⁹/L; Neutrophil count ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L; Creatinine ≤ 1.0 × upper limit of normal (ULN), blood urea nitrogen (BUN) ≤ 1.0 × ULN; Alanine aminotransferase (ALT) ≤ 1.5 × ULN; Aspartate aminotransferase (AST) ≤ 1.5 × ULN; Alkaline phosphatase (ALP) ≤ 1.5 × ULN; Total bilirubin (TBIL) ≤ 1.5 × ULN; Urine protein negative; normal coagulation time; normal thyroid function.
- ⑨ Patients with primary rectal cancer must have undergone no surgical interventions (excluding palliative stoma formation), chemotherapy, or other antitumor treatments from the time of diagnosis to enrollment.
Key exclusion criteria (12 listed)
- Previous treatment with anti-PD-1/L1, anti-CTLA-4 immunotherapies, or other investigational immunotherapeutic agents is excluded.
- ⑩ Known active hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, or active tuberculosis are excluded.
- ⑪ Patients with concurrent use of other immunomodulators, chemotherapeutic agents, other investigational drugs, or requiring long-term corticosteroid therapy are excluded.
- ⑫ Patients with psychiatric disorders, substance abuse, or social issues that may affect compliance, as determined upon physician review, are excluded.
- ⑬ Patients with allergies or contraindications to the investigational drug(s) are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| short-course radiotherapy that preserves tumor-draining lymph nodesPatients with stage II-III pMMR/MSS locally advanced rectal cancer receive neoadjuvant therapy with short-course radiotherapy that preserves tumor-draining lymph nodes, followed by 4 cycles of PD-1 inhibitors | Radiation | Experimental arm |
Primary outcome
pathologic complete response rate
Time frame: Perioperative
Defined as the absence of residual tumor cells in the surgically resected specimen after neoadjuvant therapy, including both the primary site and lymph nodes.
11 secondary outcomes
tumor regression grade
Time frame: Perioperative
R0 Resection Rate
Time frame: Perioperative
30-Day Postoperative Complication Rate
Time frame: within the first 30 days after the operation
3-Year Local-Regional Recurrence Rate
Time frame: 3 years following surgery
3-Year Distant Metastasis Rate
Time frame: 3 years following the surgery
3-Year Disease-Free Survival (DFS) Rate
Time frame: 3 years following surgery
3-Year Overall Survival (OS) Rate
Time frame: 3 years following surgery.
Toxicity Profile During Neoadjuvant Therapy (Graded by CTCAE v5.0)
Time frame: From the initiation of neoadjuvant therapy until 90 days after the last dose
EORTC QLQ-C30 questionnaire score
Time frame: Baseline and very 3 months postoperatively until 3 years
EORTC QLQ-CR29 questionnaire score
Time frame: Baseline and very 3 months postoperatively until 3 years
the Low Anterior Resection Syndrome score
Time frame: Baseline and very 3 months postoperatively until 3 years
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 6 Feb 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing short-course radiotherapy that preserves tumor-draining lymph nodes in people with Rectal Cancer and Radiotherapy, run by Peking University Cancer Hospital & Institute.
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 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: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yangzi Zhang, MD (0086-15210821349, zyzfly77@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic complete response rate (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.