Colorectal CancerPhase 2NCT07353268
Phase Ib/II Study of QL1706 + Fruquintinib + SCRT vs. Standard Third-Line Therapy in Unresectable Liver-Metastatic pMMR/MSS Colorectal Cancer: Safety, Tolerability, and Efficacy.
A Phase 2 study testing QL1706 + Fruquintinib + Short-Course Ablative Radiotherapy (SCART) and Standard Third-Line Therapy in people with Colorectal Cancer, run by Tao Zhang at 1 site in China.
Trial summary
This study is designed to evaluate the safety, tolerability, and efficacy of Epalolitovoreli Monoclonal Antibody (QL1706) combined with Fruquintinib and Short-Course Radiotherapy (SCRT), compared with standard third-line therapy, in the treatment of patients with unresectable liver-metastatic pMMR/MSS colorectal… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- QL1706 + Fruquintinib + Short-Course Ablative Radiotherapy (SCART) and Standard Third-Line Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2026to 31 Dec 2027
- 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
- Signed written informed consent, and ability to comply with the scheduled visits and related procedures as specified in the protocol.
- Age ≥18 years and ≤75 years, male or female.
- Histologically or cytologically confirmed metastatic colorectal cancer with unresectable liver metastasis(es) measuring ≥5 cm in the longest diameter.
- Confirmed pMMR (proficient mismatch repair) or MSS (microsatellite stable) status by immunohistochemistry (IHC), next-generation sequencing (NGS), or PCR testing.
- Disease progression after, intolerance to, lack of access to, or refusal of standard second-line therapy.
- Baseline* hematologic tests (within 7 days prior to the first dose of study drug) meeting the following criteria:
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- Hemoglobin ≥90 g/L.
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L.
- Platelet count ≥100 × 10⁹/L.
- Eosinophil count ≤1.5 × Upper Limit of Normal (ULN).
- Baseline serum biochemical tests (within 7 days prior to the first dose) meeting the following criteria:
- Total bilirubin ≤1.5 × ULN (if total bilirubin >1.5 × ULN but direct bilirubin ≤ ULN, enrollment is permitted).
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3 × ULN.
- Serum creatinine ≤1.5 × ULN or creatinine clearance (CCr) ≥45 mL/min (calculated using the Cockcroft-Gault formula with actual body weight).
- Albumin ≥30 g/L.
- Baseline coagulation tests (within 7 days prior to the first dose) meeting the following criteria:
- International normalized ratio (INR) ≤1.5 × ULN (or ≤3 × ULN if on stable-dose anticoagulation therapy).
- Partial thromboplastin time (PTT) [or activated partial thromboplastin time (aPTT)] ≤1.5 × ULN (or ≤3 × ULN if on stable-dose anticoagulation therapy).
- Baseline urinalysis (within 7 days prior to the first dose) meeting the following criterion: Urine protein (UPRO) <2+ or 24-hour urine protein quantification <1 g.
- At least one measurable lesion as defined by RECIST v1.1 criteria.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Life expectancy ≥3 months.
- For female patients of childbearing potential or male patients with partners of childbearing potential, agreement to use effective contraception strictly throughout the treatment period and for 6 months thereafter.
Who cannot join
- 1. History of allergy to any study drug, including Epalolitovoreli Monoclonal Antibody and Fruquintinib.
- 2. Pregnant or breastfeeding women, or women planning to become pregnant within 6 months before, during, or after the last dose of study drug.
- 3. Known history of active seizures, active central nervous system metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal metastases; newly diagnosed brain or leptomeningeal metastases.
- 4. Cardiovascular or cerebrovascular diseases with significant clinical implications, including:
- Ventricular arrhythmias or other uncontrolled arrhythmias requiring medical intervention (e.g., antiarrhythmic medication).
- Severe conduction disorders (e.g., third-degree atrioventricular block).
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- Heart rate-corrected QT interval (QTc, calculated using Fridericia's formula) ≥480 ms.
- Uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg), history of hypertensive crisis or hypertensive encephalopathy.
- History of myocarditis.
- Current congestive heart failure requiring treatment.
- New York Heart Association (NYHA) Class III or IV cardiovascular disease.
- Acute coronary syndrome (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to the first dose.
- Cerebrovascular accident or transient ischemic attack within 6 months prior to the first dose.
- Interstitial lung disease, pulmonary fibrosis, pneumoconiosis, drug-related pneumonia, radiation pneumonitis requiring steroid or other treatment, severe pulmonary dysfunction, or history of other forms of restrictive lung disease.
- 5. History of allergic constitution, asthma, or atopic dermatitis. 6. Patients with massive pleural effusion or massive ascites. 7. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic treatment.
- 8. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- 9. Known or suspected hypersensitivity to the study drugs or any of their excipients.
- 10. History of significant toxicity related to immune checkpoint inhibitors or Fruquintinib-class drugs that led to permanent discontinuation of the treatment.
- 11. Residual toxicity > Grade 1 from any prior anti-tumor therapy (except for persistent Grade 2 alopecia, peripheral neuropathy, decreased hemoglobin, and hypomagnesemia).
- 12. Active uncontrolled bleeding, known bleeding tendency, severely unhealed wounds, ulcers, or fractures; such as esophageal or gastric varices requiring immediate intervention (e.g., ligation or sclerotherapy); or evidence of portal hypertension deemed by the investigator to confer a high risk of bleeding.
- 13. Patients with risk of bowel obstruction (except surgically cured or completely resolved obstruction) or gastrointestinal perforation within 28 days prior to the first dose in this study (including, but not limited to, acute diverticulitis, intra-abdominal abscess, abdominal cancer, history of gastrointestinal perforation and/or fistula within 6 months prior to screening).
- 14. Patients with current or recent (within 6 months) significant gastrointestinal disease or conditions, including:
- History of clinically significant gastrointestinal bleeding. b) Active peptic ulcer. c) Diarrhea ≥ Grade 2 within 2 weeks prior to the first dose. 15. Patients with uncontrolled tumor-related pain or symptomatic hypercalcemia. 16. Known positive HIV test, active Hepatitis B, Hepatitis C (HCV), tuberculosis, or history of such infections. Exceptions are as follows:
- Patients who are HBsAg positive or HBcAb positive must have HBV DNA ≤2.5 × 10³ copies/mL or ≤500 IU/mL or below the limit of detection to be eligible.
- Patients with positive HCV serology are eligible if HCV RNA is negative or below the limit of detection.
- Patients who have received HCV treatment and have undetectable viral loads are eligible.
- 17. Severe/active/uncontrolled infection requiring systemic intravenous antibiotic therapy, or unexplained fever (>38°C) within 2 weeks prior to the first dose.
- 18. Diagnosis of another malignancy within 5 years prior to the first dose, except for radically treated basal cell carcinoma, squamous cell carcinoma of the skin, radically resected carcinoma in situ, radically treated localized prostate cancer, papillary thyroid carcinoma, etc.
- 19. Prohibited medications and other treatments (patients must not receive any of the following):
- Any chemotherapy or small molecule targeted therapy within 2 weeks or 5 half-lives (whichever is shorter) prior to the first dose, without delayed toxicity.
- Any monoclonal antibody therapy within 4 weeks prior to the first dose.
- Participation in any interventional clinical trial involving medical devices or other therapies within 2 weeks prior to the first dose.
- Palliative radiotherapy within 2 weeks prior to the first dose.
- Live vaccines for infectious disease prevention within 4 weeks prior to the first dose.
- Immunosuppressive or systemic corticosteroid therapy (>10 mg/day prednisone equivalent) within 2 weeks prior to the first dose.
- For patients on anticoagulant therapy, coagulation parameters are not stably controlled within the target range, or there is unstable thrombosis, pulmonary embolism events, or clinically significant bleeding events within the past 6 months.
- Any major surgery within 4 weeks prior to the first dose. 20. Any disease, treatment, laboratory abnormality, history of substance abuse, or current evidence that, in the investigator's judgment, may compromise the patient's safety, interfere with obtaining informed consent, affect patient compliance, or impact the safety evaluation of the study drug.
- 21. Patients deemed unsuitable for participation in this study by the investigator.
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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Tao Zhang, MD,PHD, 862785871982, 1277577866@qq.com
Zhenyu Lin, MD, 15827130393, tojilin@gmail.com
About this study
Official title: A Phase Ib/II Study Evaluating the Safety, Tolerability, and Efficacy of Epalolitovoreli Monoclonal Antibody (QL1706) and Fruquintinib Combined With Short-Course Radiotherapy (SCRT) Versus Standard Third-Line Therapy in Patients With Unresectable Liver-Metastatic pMMR/MSS Colorectal Cancer.
This study is designed to evaluate the safety, tolerability, and efficacy of Epalolitovoreli Monoclonal Antibody (QL1706) combined with Fruquintinib and Short-Course Radiotherapy (SCRT), compared with standard third-line therapy, in the treatment of patients with unresectable liver-metastatic pMMR/MSS colorectal cancer.
- Conditions
- Colorectal Cancer
- Being tested
- QL1706 + Fruquintinib + Short-Course Ablative Radiotherapy (SCART), Standard Third-Line Therapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1706 + Fruquintinib + Short-Course Ablative Radiotherapy (SCART)Drug
Patients will receive the PD-1/CTLA-4 bispecific antibody Epalolitovoreli Monoclonal Antibody (QL1706) at a dose of 5 mg/kg by intravenous infusion every 3 weeks (Q3W).
Patients will concomitantly receive oral Fruquintinib once daily (QD). The dose will be determined in a Phase Ib dose-escalation phase exploring 3 mg and 4 mg QD levels, using a modified 3+3 design to establish the Recommended Phase II Dose (RP2D).
Patients will undergo Short-Course Ablative Radiotherapy (SCART) to the liver metastasis/metastases. The prescribed dose is 15 Gy in 3 fractions to the Gross Tumor Volume (GTV) and 45-72 Gy in 3 fractions to the Subclinical Target Volume (STV).
Treatment with QL1706 and Fruquintinib will continue until disease progression, unacceptable toxicity, or other protocol-specified discontinuation criteria.
Standard Third-Line TherapyDrug
Patients will receive one of the following standard-of-care third-line therapies for metastatic colorectal cancer, selected by the investigator based on the patient's prior treatment history and comprehensive condition:
Cetuximab with or without Irinotecan (for patients not previously treated with cetuximab).
Regorafenib. Fruquintinib. Trifluridine/Tipiracil (TAS-102) with or without Bevacizumab.
| Study group | Role | What they receive |
|---|---|---|
| QL1706 + Fruquintinib + Short-Course Ablative Radiotherapy (SCART) | Experimental | Patients will receive the PD-1/CTLA-4 bispecific antibody Epalolitovoreli Monoclonal Antibody (QL1706) at a dose of 5 mg/kg by intravenous infusion every 3 weeks (Q3W).
Patients will concomitantly receive oral Fruquintinib once daily (QD). The dose will be determined in a Phase Ib dose-escalation phase exploring 3 mg and 4 mg QD levels, using a modified 3+3 design to establish the Recommended Phase II Dose (RP2D).
Patients will undergo Short-Course Ablative Radiotherapy (SCART) to the liver metastasis/metastases. The prescribed dose is 15 Gy in 3 fractions to the Gross Tumor Volume (GTV) and 45-72 Gy in 3 fractions to the Subclinical Target Volume (STV).
Treatment with QL1706 and Fruquintinib will continue until disease progression, unacceptable toxicity, or other protocol-specified discontinuation criteria. Receives: Drug: QL1706 + Fruquintinib + Short-Course Ablative Radiotherapy (SCART) |
| Standard Third-Line Therapy | Active comparator | Patients will receive one of the following standard-of-care third-line therapies for metastatic colorectal cancer, selected by the investigator based on the patient's prior treatment history and comprehensive condition:
Cetuximab with or without Irinotecan (for patients not previously treated with cetuximab).
Regorafenib. Fruquintinib. Trifluridine/Tipiracil (TAS-102) with or without Bevacizumab. Receives: Drug: Standard Third-Line Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival（PFS）
Progression-free survival (PFS) is defined as the time from the initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever comes first.
Measured: an expected average of 6 months
Secondary outcomes (2)
Overall Survival
The time from the date of randomization to the death caused by any cause
Measured: an expected average of 5 years
dverse events (AEs) were graded according to the NCI CTCAE version 5·0
Adverse events and surgical safety
Measured: an expected average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start21 Jan 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tao Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tao Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Tao Zhang, MD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353268
- Sponsor's protocol ID
- ZLK20250622
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study Evaluating the Safety, Tolerability, and Efficacy of Epalolitovoreli Monoclonal Antibody (QL1706) and Fruquintinib Combined With Short-Course Radiotherapy (SCRT) Versus Standard Third-Line Therapy in Patients With Unresectable Liver-Metastatic pMMR/MSS Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT07353268
- Acronym / sponsor ID
- ZLK20250622
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Tao ZhangUniversity, hospital or other
- Study start
- 21 Jan 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Jan 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 is designed to evaluate the safety, tolerability, and efficacy of Epalolitovoreli Monoclonal Antibody (QL1706) combined with Fruquintinib and Short-Course Radiotherapy (SCRT), compared with standard third-line therapy, in the treatment of patients with unresectable liver-metastatic pMMR/MSS colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL1706 + Fruquintinib + Short-Course Ablative Radiotherapy (SCART) | Experimental | Drug: QL1706 + Fruquintinib + Short-Course Ablative Radiotherapy (SCART)Patients will receive the PD-1/CTLA-4 bispecific antibody Epalolitovoreli Monoclonal Antibody (QL1706) at a dose of 5 mg/kg by intravenous infusion every 3 weeks (Q3W). Patients will concomitantly receive oral Fruquintinib once daily (QD). The dose will be determined in a Phase Ib dose-escalation phase exploring 3 mg and 4 mg QD levels, using a modified 3+3 design to establish the Recommended Phase II Dose (RP2D). Patients will undergo Short-Course Ablative Radiotherapy (SCART) to the liver metastasis/metastases. The prescribed dose is 15 Gy in 3 fractions to the Gross Tumor Volume (GTV) and 45-72 Gy in 3 fractions to the Subclinical Target Volume (STV). Treatment with QL1706 and Fruquintinib will continue until disease progression, unacceptable toxicity, or other protocol-specified discontinuation criteria. |
| Standard Third-Line Therapy | Active comparator | Drug: Standard Third-Line TherapyPatients will receive one of the following standard-of-care third-line therapies for metastatic colorectal cancer, selected by the investigator based on the patient's prior treatment history and comprehensive condition: Cetuximab with or without Irinotecan (for patients not previously treated with cetuximab). Regorafenib. Fruquintinib. Trifluridine/Tipiracil (TAS-102) with or without Bevacizumab. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Signed written informed consent, and ability to comply with the scheduled visits and related procedures as specified in the protocol.
- Age ≥18 years and ≤75 years, male or female.
- Histologically or cytologically confirmed metastatic colorectal cancer with unresectable liver metastasis(es) measuring ≥5 cm in the longest diameter.
- Confirmed pMMR (proficient mismatch repair) or MSS (microsatellite stable) status by immunohistochemistry (IHC), next-generation sequencing (NGS), or PCR testing.
- Disease progression after, intolerance to, lack of access to, or refusal of standard second-line therapy.
Key exclusion criteria (38 listed)
- 1. History of allergy to any study drug, including Epalolitovoreli Monoclonal Antibody and Fruquintinib.
- 2. Pregnant or breastfeeding women, or women planning to become pregnant within 6 months before, during, or after the last dose of study drug.
- 3. Known history of active seizures, active central nervous system metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal metastases; newly diagnosed brain or leptomeningeal metastases.
- 4. Cardiovascular or cerebrovascular diseases with significant clinical implications, including:
- 5. History of allergic constitution, asthma, or atopic dermatitis. 6. Patients with massive pleural effusion or massive ascites. 7. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic treatment.
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 |
|---|---|---|
| QL1706 + Fruquintinib + Short-Course Ablative Radiotherapy (SCART)Patients will receive the PD-1/CTLA-4 bispecific antibody Epalolitovoreli Monoclonal Antibody (QL1706) at a dose of 5 mg/kg by intravenous infusion every 3 weeks (Q3W). Patients will concomitantly receive oral Fruquintinib once daily (QD). The dose will be determined in a Phase Ib dose-escalation phase exploring 3 mg and 4 mg QD levels, using a modified 3+3 design to establish the Recommended Phase II Dose (RP2D). Patients will undergo Short-Course Ablative Radiotherapy (SCART) to the liver metastasis/metastases. The prescribed dose is 15 Gy in 3 fractions to the Gross Tumor Volume (GTV) and 45-72 Gy in 3 fractions to the Subclinical Target Volume (STV). Treatment with QL1706 and Fruquintinib will continue until disease progression, unacceptable toxicity, or other protocol-specified discontinuation criteria. | Drug | QL1706 + Fruquintinib + Short-Course Ablative Radiotherapy (SCART) |
| Standard Third-Line TherapyPatients will receive one of the following standard-of-care third-line therapies for metastatic colorectal cancer, selected by the investigator based on the patient's prior treatment history and comprehensive condition: Cetuximab with or without Irinotecan (for patients not previously treated with cetuximab). Regorafenib. Fruquintinib. Trifluridine/Tipiracil (TAS-102) with or without Bevacizumab. | Drug | Standard Third-Line Therapy |
Primary outcome
Progression Free Survival（PFS）
Time frame: an expected average of 6 months
Progression-free survival (PFS) is defined as the time from the initiation of study treatment to the first occurrence of disease progression or death from any cause, whichever comes first.
2 secondary outcomes
Overall Survival
Time frame: an expected average of 5 years
dverse events (AEs) were graded according to the NCI CTCAE version 5·0
Time frame: an expected average of 1.5 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 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Tao Zhang, MD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 QL1706 + Fruquintinib + Short-Course Ablative Radiotherapy (SCART) and Standard Third-Line Therapy in people with Colorectal Cancer, run by Tao Zhang 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 23 inclusion and 38 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 20 Jan 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 Zhenyu Lin, MD (027-83262683, whxhlzy@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival（PFS） (time frame: an expected average of 6 months). 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 20 Jan 2026.