Rectal NeoplasmsPhase 2NCT07543848
A Prospective, Multicenter, Single-Arm Phase II Exploratory Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Treatment for Locally Advanced (cT1-3N0M0) Rectal Cancer
A Phase 2 study testing Serplulimab, Oncolytic Virus H101 and XELOX Chemotherapy in people with Rectal Neoplasms and Rectal Adenocarcinoma, run by Chongqing University Cancer Hospital at 1 site in China.
Trial summary
This study aims to evaluate the safety and effectiveness of a combination treatment including a PD-1 inhibitor (serplulimab), oncolytic virus H101, short-course radiotherapy, and XELOX chemotherapy as total neoadjuvant therapy in patients with locally advanced low rectal cancer (cT1-3N0M0). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Neoplasms, Rectal Adenocarcinoma
- What is being tested?
- Serplulimab, Oncolytic Virus H101 and XELOX Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 31 Dec 2028
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria:
- Age 18 to 80 years, male or female.
- Histologically confirmed low rectal adenocarcinoma, with tumor located ≤5 cm from the anal verge.
- Clinical stage T1-3N0M0 according to AJCC staging criteria.
- Mismatch repair-proficient (pMMR) or microsatellite stable (MSS) tumor confirmed by immunohistochemistry or genetic testing.
- No prior anti-tumor treatment.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, with an expected survival of at least 3 months.
- Adequate organ function, including:
- Absolute neutrophil count ≥1.5 × 10^9/L
- Platelet count ≥100 × 10^9/L
- Hemoglobin ≥9 g/dL
- Serum albumin ≥3 g/dL
- Total bilirubin ≤1.5 × upper limit of normal (ULN)
- ALT and AST ≤2 × ULN
- Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min
- INR or PT ≤1.5 × ULN, and aPTT ≤1.5 × ULN
- Thyroid function within normal range or adequately controlled.
- Negative pregnancy test for women of childbearing potential.
- Willingness to use effective contraception during the study and for 12 months after treatment.
- Ability to understand and willingness to sign a written informed consent form.
- Willingness and ability to comply with study procedures and follow-up.
Who cannot join
- Participants will be excluded if they meet any of the following criteria:
- Histology other than rectal adenocarcinoma (e.g., gastrointestinal stromal tumor, lymphoma).
- Prior pelvic radiotherapy.
- Prior treatment with PD-1, PD-L1, or CTLA-4 inhibitors.
- Known allergy to study drugs or their components.
- History of other malignancies, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid carcinoma.
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- Active autoimmune disease or history of autoimmune disease requiring systemic treatment.
- Immunodeficiency, including HIV infection, or history of organ transplantation.
- History of interstitial lung disease or non-infectious pneumonitis.
- Active tuberculosis infection or history of untreated tuberculosis.
- Active hepatitis B or hepatitis C infection.
- Severe cardiovascular, pulmonary, or renal disease.
- Uncontrolled hypertension despite medication.
- History of substance abuse (alcohol or drugs).
- Active uncontrolled infection.
- Use of systemic immunosuppressive therapy.
- Pregnant or breastfeeding women.
- Any condition that, in the investigator's opinion, may interfere with study participation or safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Bo Yi, MD, +86-137-8617-9533, yibo2018pro@126.com
About this study
Official title: A Prospective, Multicenter, Single-Arm Phase II Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (cT1-3N0M0)
This study aims to evaluate the safety and effectiveness of a combination treatment including a PD-1 inhibitor (serplulimab), oncolytic virus H101, short-course radiotherapy, and XELOX chemotherapy as total neoadjuvant therapy in patients with locally advanced low rectal cancer (cT1-3N0M0).
In this prospective, multicenter, single-arm phase II study, eligible patients will receive a standardized treatment regimen consisting of intratumoral injection of oncolytic virus H101, short-course radiotherapy, chemotherapy, and immunotherapy over multiple cycles. Tumor response will be assessed using imaging, endoscopy, and clinical evaluation after completion of treatment.
Read more
The primary objective is to determine the 1-year clinical complete response rate. Secondary outcomes include tumor response rate, organ preservation rate, survival outcomes, and treatment safety.
The results of this study may help improve treatment strategies for rectal cancer, increase the rate of complete response, and provide more opportunities for organ preservation while maintaining safety.
Read the detailed description
Rectal cancer is a common malignancy with a significant impact on patient survival and quality of life. For patients with locally advanced rectal cancer, the current standard treatment typically includes neoadjuvant chemoradiotherapy followed by surgery. Although this approach can achieve tumor control, the rate of complete response remains limited, and surgery may result in permanent stoma or impaired bowel, urinary, and sexual function. Therefore, there is a need to develop more effective treatment strategies that can improve tumor response and increase the chance of organ preservation.
Most rectal cancers are mismatch repair-proficient or microsatellite stable (pMMR/MSS), which generally show limited response to immunotherapy alone. Recent studies suggest that combination strategies may enhance treatment efficacy by modifying the tumor microenvironment and improving immune response.
This study is designed to evaluate a novel combination treatment approach that includes a PD-1 inhibitor (serplulimab), an oncolytic virus (H101), short-course radiotherapy, and XELOX chemotherapy as total neoadjuvant therapy. The oncolytic virus H101 selectively infects and destroys tumor cells while stimulating anti-tumor immune responses. Radiotherapy may further enhance immune activation by promoting tumor antigen release, and chemotherapy can improve tumor sensitivity to treatment. The combination of these therapies is expected to have a synergistic effect. :contentReference[oaicite:0]{index=0}
This is a prospective, multicenter, single-arm phase II clinical trial. Approximately 20 patients with low rectal adenocarcinoma (cT1-3N0M0) will be enrolled. All participants will receive a standardized treatment regimen consisting of intratumoral injections of H101, short-course radiotherapy, and systemic treatment with serplulimab and XELOX chemotherapy over multiple cycles. :contentReference[oaicite:1]{index=1}
Tumor response will be evaluated after completion of the total neoadjuvant therapy using imaging, endoscopy, and clinical assessments. Patients who achieve clinical complete response may enter a non-surgical management strategy with close follow-up, while others may proceed to surgery based on clinical evaluation.
The primary endpoint of this study is the 1-year clinical complete response rate. Secondary endpoints include objective response rate, organ preservation rate, tumor downstaging, recurrence-free survival, disease-free survival, overall survival, and safety outcomes. :contentReference[oaicite:2]{index=2}
The findings of this study may provide evidence for a new treatment strategy for rectal cancer that improves tumor response and increases the possibility of organ preservation while maintaining acceptable safety.
- Conditions
- Rectal Neoplasms, Rectal Adenocarcinoma
- Being tested
- Serplulimab, Oncolytic Virus H101, XELOX Chemotherapy, Short-course Radiotherapy
- Keywords
- Rectal Cancer, Total Neoadjuvant Therapy, Combination Therapy, Serplulimab, PD-1 Inhibitor, Oncolytic Virus H101, XELOX Chemotherapy, Short-course Radiotherapy, Organ Preservation, Clinical Complete Response
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerplulimabDrug
Serplulimab is a humanized monoclonal antibody targeting programmed cell death protein-1 (PD-1). It will be administered intravenously at a fixed dose of 300 mg on Day 1 of each 3-week cycle for a total of 6 cycles. Serplulimab is given in combination with chemotherapy, radiotherapy, and oncolytic virus therapy as part of total neoadjuvant treatment. The aim is to enhance anti-tumor immune response and improve treatment efficacy.
Oncolytic Virus H101Biological
H101 is a recombinant human adenovirus type 5 oncolytic virus that selectively replicates in and lyses tumor cells while stimulating anti-tumor immune responses. It will be administered by intratumoral injection on Day 1 of Cycle 1 and Day 1 of Cycle 4. The dose will be determined based on tumor size. H101 is used in combination with immunotherapy, chemotherapy, and radiotherapy to enhance tumor cell killing and improve immune activation.
XELOX ChemotherapyDrug
XELOX chemotherapy consists of oxaliplatin and capecitabine. Oxaliplatin will be administered intravenously at a dose of 130 mg/m² on Day 1, and capecitabine will be given orally at a dose of 1000 mg/m² twice daily from Day 1 to Day 14 of each 3-week cycle. A total of 6 cycles will be administered. Chemotherapy is combined with immunotherapy, radiotherapy, and oncolytic virus therapy to improve tumor response.
Short-course RadiotherapyRadiation
Short-course radiotherapy will be delivered to the rectal tumor using intensity-modulated radiation therapy (IMRT). The total dose is 25 Gy administered in 5 fractions over one week. Radiotherapy is given during the treatment course in combination with immunotherapy, chemotherapy, and oncolytic virus therapy. It aims to enhance local tumor control and stimulate anti-tumor immune response.
| Study group | Role | What they receive |
|---|---|---|
| Serplulimab + H101 + Short-course Radiotherapy + XELOX | Experimental | Participants with low rectal adenocarcinoma (cT1-3N0M0) will receive total neoadjuvant therapy consisting of intratumoral oncolytic virus H101, short-course radiotherapy, serplulimab, and XELOX chemotherapy. H101 will be administered on Day 1 of Cycle 1 and Day 1 of Cycle 4. Short-course radiotherapy will be delivered during treatment. Serplulimab and XELOX chemotherapy will be administered every 3 weeks according to the study protocol. Tumor response will be assessed after completion of treatment. Receives: Drug: Serplulimab; Biological: Oncolytic Virus H101; Drug: XELOX Chemotherapy; Radiation: Short-course Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Clinical Complete Response Rate
Clinical complete response (cCR) is defined as no evidence of residual tumor based on digital rectal examination, endoscopy showing mucosal healing or scar, and imaging (MRI or CT) without tumor signal or metabolic activity, and no distant metastasis. The proportion of patients achieving cCR and maintaining it for at least 1 year will be evaluated.
Measured: 1 year after completion of treatment
Secondary outcomes (5)
Objective Response Rate
The proportion of participants who achieve complete response (CR) or partial response (PR) based on imaging assessments according to RECIST criteria.
Measured: Up to 6 months after treatment initiation
Organ Preservation Rate
The proportion of patients who achieve clinical complete response and avoid radical surgery, thereby preserving the rectum.
Measured: 1 year after completion of treatment
Disease-Free Survival
Time from treatment initiation to the occurrence of disease recurrence, metastasis, or death from any cause.
Measured: Up to 3 years
Overall Survival
Time from treatment initiation to death from any cause.
Measured: Up to 3 years
Incidence of Adverse Events
The incidence and severity of treatment-related adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: From treatment initiation up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Yi, Chongqing University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543848
- Sponsor's protocol ID
- 20260115101749430
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient privacy concerns and institutional data protection policies. De-identified data may be available upon reasonable request to the corresponding investigator, subject to approval.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm Phase II Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (cT1-3N0M0)
- ClinicalTrials.gov ID
- NCT07543848
- Acronym / sponsor ID
- 20260115101749430
- Conditions
- Rectal Neoplasms, Rectal Adenocarcinoma
- Keywords
- Rectal Cancer, Total Neoadjuvant Therapy, Combination Therapy, Serplulimab, PD-1 Inhibitor, Oncolytic Virus H101, XELOX Chemotherapy, Short-course Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Apr 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 safety and effectiveness of a combination treatment including a PD-1 inhibitor (serplulimab), oncolytic virus H101, short-course radiotherapy, and XELOX chemotherapy as total neoadjuvant therapy in patients with locally advanced low rectal cancer (cT1-3N0M0).
In this prospective, multicenter, single-arm phase II study, eligible patients will receive a standardized treatment regimen consisting of intratumoral injection of oncolytic virus H101, short-course radiotherapy, chemotherapy, and immunotherapy over multiple cycles. Tumor response will be assessed using imaging, endoscopy, and clinical evaluation after completion of treatment.
The primary objective is to determine the 1-year clinical complete response rate. Secondary outcomes include tumor response rate, organ preservation rate, survival outcomes, and treatment safety.
The results of this study may help improve treatment strategies for rectal cancer, increase the rate of complete response, and provide more opportunities for organ preservation while maintaining safety.
Detailed description
Rectal cancer is a common malignancy with a significant impact on patient survival and quality of life. For patients with locally advanced rectal cancer, the current standard treatment typically includes neoadjuvant chemoradiotherapy followed by surgery. Although this approach can achieve tumor control, the rate of complete response remains limited, and surgery may result in permanent stoma or impaired bowel, urinary, and sexual function. Therefore, there is a need to develop more effective treatment strategies that can improve tumor response and increase the chance of organ preservation.
Most rectal cancers are mismatch repair-proficient or microsatellite stable (pMMR/MSS), which generally show limited response to immunotherapy alone. Recent studies suggest that combination strategies may enhance treatment efficacy by modifying the tumor microenvironment and improving immune response.
This study is designed to evaluate a novel combination treatment approach that includes a PD-1 inhibitor (serplulimab), an oncolytic virus (H101), short-course radiotherapy, and XELOX chemotherapy as total neoadjuvant therapy. The oncolytic virus H101 selectively infects and destroys tumor cells while stimulating anti-tumor immune responses. Radiotherapy may further enhance immune activation by promoting tumor antigen release, and chemotherapy can improve tumor sensitivity to treatment. The combination of these therapies is expected to have a synergistic effect. :contentReference[oaicite:0]{index=0}
This is a prospective, multicenter, single-arm phase II clinical trial. Approximately 20 patients with low rectal adenocarcinoma (cT1-3N0M0) will be enrolled. All participants will receive a standardized treatment regimen consisting of intratumoral injections of H101, short-course radiotherapy, and systemic treatment with serplulimab and XELOX chemotherapy over multiple cycles. :contentReference[oaicite:1]{index=1}
Tumor response will be evaluated after completion of the total neoadjuvant therapy using imaging, endoscopy, and clinical assessments. Patients who achieve clinical complete response may enter a non-surgical management strategy with close follow-up, while others may proceed to surgery based on clinical evaluation.
The primary endpoint of this study is the 1-year clinical complete response rate. Secondary endpoints include objective response rate, organ preservation rate, tumor downstaging, recurrence-free survival, disease-free survival, overall survival, and safety outcomes. :contentReference[oaicite:2]{index=2}
The findings of this study may provide evidence for a new treatment strategy for rectal cancer that improves tumor response and increases the possibility of organ preservation while maintaining acceptable safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serplulimab + H101 + Short-course Radiotherapy + XELOX | Experimental | Drug: Serplulimab, Biological: Oncolytic Virus H101, Drug: XELOX Chemotherapy, Radiation: Short-course RadiotherapyParticipants with low rectal adenocarcinoma (cT1-3N0M0) will receive total neoadjuvant therapy consisting of intratumoral oncolytic virus H101, short-course radiotherapy, serplulimab, and XELOX chemotherapy. H101 will be administered on Day 1 of Cycle 1 and Day 1 of Cycle 4. Short-course radiotherapy will be delivered during treatment. Serplulimab and XELOX chemotherapy will be administered every 3 weeks according to the study protocol. Tumor response will be assessed after completion of treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Participants must meet all of the following criteria:
- Age 18 to 80 years, male or female.
- Histologically confirmed low rectal adenocarcinoma, with tumor located ≤5 cm from the anal verge.
- Clinical stage T1-3N0M0 according to AJCC staging criteria.
- Mismatch repair-proficient (pMMR) or microsatellite stable (MSS) tumor confirmed by immunohistochemistry or genetic testing.
Key exclusion criteria (18 listed)
- Participants will be excluded if they meet any of the following criteria:
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 |
|---|---|---|
| SerplulimabSerplulimab is a humanized monoclonal antibody targeting programmed cell death protein-1 (PD-1). It will be administered intravenously at a fixed dose of 300 mg on Day 1 of each 3-week cycle for a total of 6 cycles. Serplulimab is given in combination with chemotherapy, radiotherapy, and oncolytic virus therapy as part of total neoadjuvant treatment. The aim is to enhance anti-tumor immune response and improve treatment efficacy. | Drug | Serplulimab + H101 + Short-course Radiotherapy + XELOX |
| Oncolytic Virus H101H101 is a recombinant human adenovirus type 5 oncolytic virus that selectively replicates in and lyses tumor cells while stimulating anti-tumor immune responses. It will be administered by intratumoral injection on Day 1 of Cycle 1 and Day 1 of Cycle 4. The dose will be determined based on tumor size. H101 is used in combination with immunotherapy, chemotherapy, and radiotherapy to enhance tumor cell killing and improve immune activation. | Biological | Serplulimab + H101 + Short-course Radiotherapy + XELOX |
| XELOX ChemotherapyXELOX chemotherapy consists of oxaliplatin and capecitabine. Oxaliplatin will be administered intravenously at a dose of 130 mg/m² on Day 1, and capecitabine will be given orally at a dose of 1000 mg/m² twice daily from Day 1 to Day 14 of each 3-week cycle. A total of 6 cycles will be administered. Chemotherapy is combined with immunotherapy, radiotherapy, and oncolytic virus therapy to improve tumor response. | Drug | Serplulimab + H101 + Short-course Radiotherapy + XELOX |
| Short-course RadiotherapyShort-course radiotherapy will be delivered to the rectal tumor using intensity-modulated radiation therapy (IMRT). The total dose is 25 Gy administered in 5 fractions over one week. Radiotherapy is given during the treatment course in combination with immunotherapy, chemotherapy, and oncolytic virus therapy. It aims to enhance local tumor control and stimulate anti-tumor immune response. | Radiation | Serplulimab + H101 + Short-course Radiotherapy + XELOX |
Primary outcome
1-year Clinical Complete Response Rate
Time frame: 1 year after completion of treatment
Clinical complete response (cCR) is defined as no evidence of residual tumor based on digital rectal examination, endoscopy showing mucosal healing or scar, and imaging (MRI or CT) without tumor signal or metabolic activity, and no distant metastasis. The proportion of patients achieving cCR and maintaining it for at least 1 year will be evaluated.
5 secondary outcomes
Objective Response Rate
Time frame: Up to 6 months after treatment initiation
Organ Preservation Rate
Time frame: 1 year after completion of treatment
Disease-Free Survival
Time frame: Up to 3 years
Overall Survival
Time frame: Up to 3 years
Incidence of Adverse Events
Time frame: From treatment initiation up to 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 22 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient privacy concerns and institutional data protection policies. De-identified data may be available upon reasonable request to the corresponding investigator, subject to approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serplulimab, Oncolytic Virus H101 and XELOX Chemotherapy in people with Rectal Neoplasms and Rectal Adenocarcinoma, run by Chongqing University Cancer 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 21 inclusion and 18 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 22 Apr 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 Bo Yi, MD (+86-137-8617-9533, yibo2018pro@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year Clinical Complete Response Rate (time frame: 1 year after completion of treatment). 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 22 Apr 2026.