Locally Advanced Low Rectal AdenocarcinomaPhase 3NCT07277842
PD-1 + FOLFOXIRI vs CAPOX as Total Neoadjuvant Therapy for pMMR Low Rectal Cancer
A Phase 3 study testing Serplulimab, FOLFOXIRI chemotherapy and CAPOX chemotherapy in people with Locally Advanced Low Rectal Adenocarcinoma and pMMR (Microsatellite Stable Rectal Cancer), run by Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this clinical trial is to find out if adding a PD-1 antibody (serplulimab) to FOLFOXIRI chemotherapy and radiotherapy works better than CAPOX chemotherapy with radiotherapy as total neoadjuvant therapy for adults with pMMR locally advanced low rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Low Rectal Adenocarcinoma, pMMR (Microsatellite Stable Rectal Cancer)
- What is being tested?
- Serplulimab, FOLFOXIRI chemotherapy and CAPOX chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2025to 29 Dec 2028
- Phase
- Phase 3
- 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
- Histologically confirmed rectal adenocarcinoma.
- pMMR status documented by immunohistochemistry (MSH1, MSH2, MSH6 and PMS2 all positive) or by MSI testing showing MSS or MSI-L.
- Primary tumor located within 5 cm from the anal verge on pelvic MRI.
- Clinical stage cT3-4bN0M0 or cTxN+M0, with or without positive mesorectal fascia (MRF) and/or extramural vascular invasion (EMVI), and assessed by the multidisciplinary team as resectable with the potential for R0 resection.
- No clinical or radiologic evidence of bowel obstruction.
- No prior colorectal surgery.
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- No prior chemotherapy or radiotherapy.
- No prior treatment with biologic agents (e.g., monoclonal antibodies), immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4), or other investigational drugs.
- Age 18 to 75 years (inclusive).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Estimated life expectancy > 2 years.
- Adequate bone marrow function: WBC > 3.5 × 10^9/L; platelets > 100 × 10^9/L; hemoglobin > 80 g/L.
- Adequate liver function: ALT and AST ≤ 1.5 × upper limit of normal (ULN); total bilirubin < 23.0 μmol/L.
- Adequate renal function: eGFR ≥ 60 mL/min/1.73 m² (CKD-EPI) or creatinine clearance (Ccr) ≥ 60 mL/min.
- Ability to understand and willingness to sign a written informed consent form.
Who cannot join
- Evidence of inguinal or lateral pelvic lymph node metastasis (lymph node short-axis diameter ≥ 7 mm or MRI features typical for metastatic lymph nodes).
- Clinically significant cardiac disease, including arrhythmias requiring anti-arrhythmic treatment (except β-blockers or digoxin), symptomatic coronary artery disease or myocardial ischemia (myocardial infarction within the last 6 months), or congestive heart failure > NYHA class II.
- Uncontrolled severe hypertension.
- History of HIV infection or active chronic hepatitis B (HBV DNA > 2 × 10^3 IU/mL) or hepatitis C (HCV RNA > 1 × 10^3 IU/mL).
- Active pulmonary tuberculosis under treatment or having received anti-tuberculosis therapy within 1 year before screening.
- Other active severe infections (as defined by NCI-CTCAE v5.0).
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- Evidence of distant metastasis outside the pelvis before treatment.
- Cachexia or decompensated organ dysfunction.
- Prior pelvic or abdominal radiotherapy.
- Multiple primary colorectal cancers.
- History of seizures requiring ongoing treatment (e.g., corticosteroids or anti-epileptic drugs).
- History of another malignancy within the past 5 years, except adequately treated cervical carcinoma in situ or basal cell carcinoma of the skin.
- Drug or alcohol abuse, or any medical, psychological, or social condition that, in the investigator's judgment, could interfere with study participation or the evaluation of study results.
- Any active autoimmune disease or history of autoimmune disease (including but not limited to interstitial pneumonia, uveitis, colitis, hepatitis, hypophysitis, nephritis, hyperthyroidism, or hypothyroidism).
- Receipt of any prophylactic vaccine against infectious diseases (e.g., influenza, varicella) within 4 weeks before enrollment.
- Requirement for long-term immunosuppressive therapy or systemic/local corticosteroids at immunosuppressive doses (equivalent to > 10 mg/day of prednisone or other corticosteroids).
- Known or suspected allergy or hypersensitivity to any study drug or to any component of the study treatments.
- Any unstable condition or other circumstance that may, in the opinion of the investigator, compromise patient safety or study compliance.
- Pregnant or breastfeeding women, or women of childbearing potential who are unwilling or unable to use adequate contraception during the study.
- Refusal or inability to provide written informed consent.
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
Sun Yat-Sen University Cancer Center
Guangzhou, None Selected, 510060
Junzhong Lin, 02087343124, linjzh@sysucc.org.cn
About this study
Official title: A Multicenter, Prospective, Phase III Randomized Controlled Trial of PD-1 Antibody Plus FOLFOXIRI Combined With Radiotherapy Versus CAPOX Combined With Radiotherapy as Total Neoadjuvant Therapy for pMMR Locally Advanced Low Rectal Cancer
The goal of this clinical trial is to find out if adding a PD-1 antibody (serplulimab) to FOLFOXIRI chemotherapy and radiotherapy works better than CAPOX chemotherapy with radiotherapy as total neoadjuvant therapy for adults with pMMR locally advanced low rectal cancer. It will also look at the safety of these treatments and how they affect long-term outcomes such as organ preservation and survival.
The main questions it aims to answer are:
Read more
Does PD-1 antibody plus FOLFOXIRI with radiotherapy improve 3-year event-free survival compared with CAPOX with radiotherapy?
Does this treatment increase the chance of clinical complete response and avoiding a permanent stoma (sphincter-preserving or non-surgical "watch-and-wait" management)?
What side effects and medical problems occur during and after these treatments?
Researchers will compare:
Group A (experimental group): PD-1 antibody (serplulimab) plus FOLFOXIRI chemotherapy combined with long-course radiotherapy as total neoadjuvant therapy.
Group B (control group): CAPOX chemotherapy combined with long-course radiotherapy as total neoadjuvant therapy.
Participants will:
Sign an informed consent form and have screening tests (physical exam, blood tests, ECG, imaging such as MRI/CT, endoscopy) to confirm they can join the trial.
Be randomly assigned (like drawing lots) to Group A or Group B. Receive several cycles of chemotherapy together with a 5-week course of pelvic radiotherapy before surgery; the experimental group will also receive PD-1 antibody during part of the chemotherapy and radiotherapy period.
Have regular clinic visits for checkups, blood tests, and assessment of side effects during treatment.
After neoadjuvant therapy, have MRI/CT and endoscopy to assess tumor response. Depending on the response, they may:
Receive surgery to remove the rectal tumor, or
If a clinical complete response is achieved and both doctor and patient agree, enter a "watch-and-wait" program instead of immediate surgery.
Provide blood samples and allow tumor tissue to be collected (for example, from biopsy and surgery) for future research (such as building PDX models and testing blood markers).
Be followed regularly for at least 5 years with clinic visits, blood tests (including CEA), imaging, and colonoscopy to check for tumor recurrence, side effects, and quality of life.
- Being tested
- Serplulimab, FOLFOXIRI chemotherapy, CAPOX chemotherapy, Long-course pelvic radiotherapy
- Keywords
- pMMR locally advanced rectal cancer, total neoadjuvant therapy, PD-1 antibody, serplulimab, watch-and-wait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerplulimabDrug
Also called PD-1 antibody
Serplulimab will be administered intravenously in combination with FOLFOXIRI chemotherapy and long-course pelvic radiotherapy as part of total neoadjuvant therapy in the experimental arm.
FOLFOXIRI chemotherapyDrug
Also called 5-fluorouracil, leucovorin, oxaliplatin, irinotecan
The FOLFOXIRI chemotherapy regimen (5-fluorouracil, leucovorin, oxaliplatin, irinotecan) will be administered according to the study protocol as part of total neoadjuvant therapy in the experimental arm, in combination with serplulimab and long-course pelvic radiotherapy.
CAPOX chemotherapyDrug
Also called Capecitabine plus oxaliplatin
The CAPOX chemotherapy regimen (capecitabine plus oxaliplatin) will be administered according to the study protocol as part of total neoadjuvant therapy in the active comparator arm, in combination with long-course pelvic radiotherapy.
Long-course pelvic radiotherapyRadiation
Also called External beam radiotherapy, Pelvic radiotherapy
Long-course pelvic external beam radiotherapy will be delivered according to institutional standards as part of total neoadjuvant therapy in both study arms, in combination with chemotherapy (FOLFOXIRI plus serplulimab in the experimental arm or CAPOX in the active comparator arm).
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Serplulimab + FOLFOXIRI + Radiotherapy | Experimental | Participants in this arm will receive a PD-1 antibody (serplulimab) in combination with FOLFOXIRI chemotherapy and long-course pelvic radiotherapy as total neoadjuvant therapy before surgery. Treatment will be given according to the study protocol, with regular safety monitoring and response assessments. Receives: Drug: Serplulimab; Drug: FOLFOXIRI chemotherapy; Radiation: Long-course pelvic radiotherapy |
| Active Comparator: CAPOX + Radiotherapy | Active comparator | Participants in this arm will receive CAPOX chemotherapy and long-course pelvic radiotherapy as total neoadjuvant therapy before surgery. Treatment will be given according to the study protocol, with regular safety monitoring and response assessments. Receives: Drug: CAPOX chemotherapy; Radiation: Long-course pelvic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year Event-Free Survival (EFS)
Event-free survival (EFS) is defined as the time from randomization to the first occurrence of any of the following events: (1) locoregional failure, including unresectable primary tumor after completion of total neoadjuvant therapy, R2 resection (macroscopic residual tumor), or local bed recurrence after R0-R1 resection; (2) distant metastasis; (3) new invasive primary colorectal cancer; or (4) death from any cause. Patients without an event at the time of analysis will be censored at the date of the last tumor assessment.
Measured: Up to 3 years after randomization
Secondary outcomes (3)
Clinical Complete Response (cCR) Rate
Proportion of participants achieving clinical complete response (cCR) after completion of total neoadjuvant therapy. cCR will be assessed by digital rectal examination, endoscopy, pelvic MRI and serum CEA according to predefined criteria (no palpable tumor, endoscopic whitening or telangiectasia only, fibrotic signal on MRI without residual tumor or nodes, and normal CEA).
Measured: At 10-14 weeks after completion of radiotherapy (response assessment prior to definitive management)
Anal Sphincter Preservation Rate
Proportion of participants who achieve anal sphincter preservation, defined as undergoing sphincter-preserving surgery (e.g., low anterior resection, intersphincteric resection) or managed with a watch-and-wait strategy without permanent stoma at last follow-up.
Measured: From randomization to definitive management (surgery or decision for watch-and-wait) and last follow-up, up to approximately 1 year after randomization
Incidence of Treatment-related Adverse Events During Total Neoadjuvant Therapy
Number and proportion of participants experiencing treatment-related adverse events during total neoadjuvant therapy, graded according to NCI-CTCAE version 5.0. Both overall adverse events and grade 3-5 toxicities related to chemotherapy, immunotherapy, or radiotherapy will be summarized.
Measured: From first dose of study treatment until 30-90 days after completion of chemotherapy/radiotherapy or surgery, up to approximately 1 year after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start29 Dec 2025 (estimated)
- Primary completion29 Dec 2028 (estimated)
- Study completion29 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Low Rectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHI-ZHONG PAN, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277842
- Sponsor's protocol ID
- 2025-FXY-302
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2025
- Last updated
- 11 Dec 2025
- 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 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Phase III Randomized Controlled Trial of PD-1 Antibody Plus FOLFOXIRI Combined With Radiotherapy Versus CAPOX Combined With Radiotherapy as Total Neoadjuvant Therapy for pMMR Locally Advanced Low Rectal Cancer
- ClinicalTrials.gov ID
- NCT07277842
- Acronym / sponsor ID
- 2025-FXY-302
- Keywords
- pMMR locally advanced rectal cancer, total neoadjuvant therapy, PD-1 antibody, serplulimab, watch-and-wait
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 29 Dec 2025 (estimated)
- Primary completion
- 29 Dec 2028 (estimated)
- Study completion
- 29 Dec 2028 (estimated)
- First posted
- 11 Dec 2025 (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.
The goal of this clinical trial is to find out if adding a PD-1 antibody (serplulimab) to FOLFOXIRI chemotherapy and radiotherapy works better than CAPOX chemotherapy with radiotherapy as total neoadjuvant therapy for adults with pMMR locally advanced low rectal cancer. It will also look at the safety of these treatments and how they affect long-term outcomes such as organ preservation and survival.
The main questions it aims to answer are:
Does PD-1 antibody plus FOLFOXIRI with radiotherapy improve 3-year event-free survival compared with CAPOX with radiotherapy?
Does this treatment increase the chance of clinical complete response and avoiding a permanent stoma (sphincter-preserving or non-surgical "watch-and-wait" management)?
What side effects and medical problems occur during and after these treatments?
Researchers will compare:
Group A (experimental group): PD-1 antibody (serplulimab) plus FOLFOXIRI chemotherapy combined with long-course radiotherapy as total neoadjuvant therapy.
Group B (control group): CAPOX chemotherapy combined with long-course radiotherapy as total neoadjuvant therapy.
Participants will:
Sign an informed consent form and have screening tests (physical exam, blood tests, ECG, imaging such as MRI/CT, endoscopy) to confirm they can join the trial.
Be randomly assigned (like drawing lots) to Group A or Group B. Receive several cycles of chemotherapy together with a 5-week course of pelvic radiotherapy before surgery; the experimental group will also receive PD-1 antibody during part of the chemotherapy and radiotherapy period.
Have regular clinic visits for checkups, blood tests, and assessment of side effects during treatment.
After neoadjuvant therapy, have MRI/CT and endoscopy to assess tumor response. Depending on the response, they may:
Receive surgery to remove the rectal tumor, or
If a clinical complete response is achieved and both doctor and patient agree, enter a "watch-and-wait" program instead of immediate surgery.
Provide blood samples and allow tumor tissue to be collected (for example, from biopsy and surgery) for future research (such as building PDX models and testing blood markers).
Be followed regularly for at least 5 years with clinic visits, blood tests (including CEA), imaging, and colonoscopy to check for tumor recurrence, side effects, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Serplulimab + FOLFOXIRI + Radiotherapy | Experimental | Drug: Serplulimab, Drug: FOLFOXIRI chemotherapy, Radiation: Long-course pelvic radiotherapyParticipants in this arm will receive a PD-1 antibody (serplulimab) in combination with FOLFOXIRI chemotherapy and long-course pelvic radiotherapy as total neoadjuvant therapy before surgery. Treatment will be given according to the study protocol, with regular safety monitoring and response assessments. |
| Active Comparator: CAPOX + Radiotherapy | Active comparator | Drug: CAPOX chemotherapy, Radiation: Long-course pelvic radiotherapyParticipants in this arm will receive CAPOX chemotherapy and long-course pelvic radiotherapy as total neoadjuvant therapy before surgery. Treatment will be given according to the study protocol, with regular safety monitoring and response assessments. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically confirmed rectal adenocarcinoma.
- pMMR status documented by immunohistochemistry (MSH1, MSH2, MSH6 and PMS2 all positive) or by MSI testing showing MSS or MSI-L.
- Primary tumor located within 5 cm from the anal verge on pelvic MRI.
- Clinical stage cT3-4bN0M0 or cTxN+M0, with or without positive mesorectal fascia (MRF) and/or extramural vascular invasion (EMVI), and assessed by the multidisciplinary team as resectable with the potential for R0 resection.
- No clinical or radiologic evidence of bowel obstruction.
Key exclusion criteria (20 listed)
- Evidence of inguinal or lateral pelvic lymph node metastasis (lymph node short-axis diameter ≥ 7 mm or MRI features typical for metastatic lymph nodes).
- Clinically significant cardiac disease, including arrhythmias requiring anti-arrhythmic treatment (except β-blockers or digoxin), symptomatic coronary artery disease or myocardial ischemia (myocardial infarction within the last 6 months), or congestive heart failure > NYHA class II.
- Uncontrolled severe hypertension.
- History of HIV infection or active chronic hepatitis B (HBV DNA > 2 × 10^3 IU/mL) or hepatitis C (HCV RNA > 1 × 10^3 IU/mL).
- Active pulmonary tuberculosis under treatment or having received anti-tuberculosis therapy within 1 year before screening.
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 |
|---|---|---|
| SerplulimabAlso: PD-1 antibodySerplulimab will be administered intravenously in combination with FOLFOXIRI chemotherapy and long-course pelvic radiotherapy as part of total neoadjuvant therapy in the experimental arm. | Drug | Experimental: Serplulimab + FOLFOXIRI + Radiotherapy |
| FOLFOXIRI chemotherapyAlso: 5-fluorouracil, leucovorin, oxaliplatin, irinotecanThe FOLFOXIRI chemotherapy regimen (5-fluorouracil, leucovorin, oxaliplatin, irinotecan) will be administered according to the study protocol as part of total neoadjuvant therapy in the experimental arm, in combination with serplulimab and long-course pelvic radiotherapy. | Drug | Experimental: Serplulimab + FOLFOXIRI + Radiotherapy |
| CAPOX chemotherapyAlso: Capecitabine plus oxaliplatinThe CAPOX chemotherapy regimen (capecitabine plus oxaliplatin) will be administered according to the study protocol as part of total neoadjuvant therapy in the active comparator arm, in combination with long-course pelvic radiotherapy. | Drug | Active Comparator: CAPOX + Radiotherapy |
| Long-course pelvic radiotherapyAlso: External beam radiotherapy, Pelvic radiotherapyLong-course pelvic external beam radiotherapy will be delivered according to institutional standards as part of total neoadjuvant therapy in both study arms, in combination with chemotherapy (FOLFOXIRI plus serplulimab in the experimental arm or CAPOX in the active comparator arm). | Radiation | Active Comparator: CAPOX + Radiotherapy, Experimental: Serplulimab + FOLFOXIRI + Radiotherapy |
Primary outcome
3-year Event-Free Survival (EFS)
Time frame: Up to 3 years after randomization
Event-free survival (EFS) is defined as the time from randomization to the first occurrence of any of the following events: (1) locoregional failure, including unresectable primary tumor after completion of total neoadjuvant therapy, R2 resection (macroscopic residual tumor), or local bed recurrence after R0-R1 resection; (2) distant metastasis; (3) new invasive primary colorectal cancer; or (4) death from any cause. Patients without an event at the time of analysis will be censored at the date of the last tumor assessment.
3 secondary outcomes
Clinical Complete Response (cCR) Rate
Time frame: At 10-14 weeks after completion of radiotherapy (response assessment prior to definitive management)
Anal Sphincter Preservation Rate
Time frame: From randomization to definitive management (surgery or decision for watch-and-wait) and last follow-up, up to approximately 1 year after randomization
Incidence of Treatment-related Adverse Events During Total Neoadjuvant Therapy
Time frame: From first dose of study treatment until 30-90 days after completion of chemotherapy/radiotherapy or surgery, up to approximately 1 year after randomization
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 11 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Serplulimab, FOLFOXIRI chemotherapy and CAPOX chemotherapy in people with Locally Advanced Low Rectal Adenocarcinoma and pMMR (Microsatellite Stable Rectal Cancer), run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 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 11 Dec 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Junzhong Lin, MD (+862087343124, linjzh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year Event-Free Survival (EFS) (time frame: Up to 3 years after randomization). 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 11 Dec 2025.