CholangiocarcinomaPhase 1NCT06490198
Phase 2 Study: OBI-833/OBI-821 Maintenance for Globo H+ Advanced Biliary Tract Cancer After Gemcitabine/Cisplatin
A Phase 1 study testing OBI-833/OBI-821 in people with Cholangiocarcinoma and Chemotherapy Effect, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
Trial summary
A Phase 2 clinical trial protocol for evaluating the efficacy and safety of OBI-833/OBI-821, a carbohydrate-conjugate vaccine combined with an immune adjuvant, as maintenance therapy in combination with first-line gemcitabine and cisplatin chemotherapy for patients with Globo H-positive advanced biliary tract cancer. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Cholangiocarcinoma, Chemotherapy Effect, Immunotherapy
- What is being tested?
- OBI-833/OBI-821
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTaiwan
- Study dates
- 31 Jul 2024to 31 Jul 2027
- Phase
- Phase 1
- 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 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 20 years.
- Histologically confirmed, unresectable advanced or metastatic biliary tract cancer, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
- Patient with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
- Patient with recurrent disease >6 months after curative surgery or >6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.
- Patient must have a documented Globo H H-score of at least 80 using a validated central IHC assay.
- Patient must have received 3±1 months of the first-line GemCis regimen (gemcitabine, 1000 mg/m2 and cisplatin, 25 mg/m2 on days 1 and 8 of each 21-day cycle), have achieved SD, PR, or CR before enrollment (as confirmed by the Investigator), and plan to continue the GemCis regimen.
Show all 13Show fewer
- At least one measurable tumor lesion according to RECIST version 1.1 as assessed by the Investigator (local radiological image assessment).
- Life expectancy ≥ 6 months.
- East Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Organ function requirements - Subjects must have adequate organ functions as defined below:
- AST/ALT ≤ 3X ULN (upper limit of normal); AST/ALT ≤ 5X ULN in the presence of liver metastases Total bilirubin ≤ 2.0 X ULN Serum creatinine ≤ 1.5X ULN ANC ≥ 1,5500 /µL Platelets ≥ 100,000/µL
- All eligible patients of childbearing potential must use effective contraception during study treatment, and for at least 2 months after the last dose of OBI-833/OBI-821. Subjects not of childbearing potential (i.e., permanently sterilized, postmenopausal) can be included in the study. Postmenopausal is defined as 12 months with no menses without an alternative medical cause.
- Understand and provide a written informed consent document according to institutional guidelines.
Who cannot join
- Patient who has CNS metastasis or spinal cord compression.
- Patient who is pregnant or breast-feeding at entry.
- Patient with splenectomy.
- Patient with HIV infection, active hepatitis B infection, or active hepatitis C infection. Patients with hepatitis B infection under anti-HBV medications are exceptionalcan be included in the study. Patients with hepatitis C infection history but inactive status are exceptionalcan be included in the study.
- Patient with any autoimmune or other disorders requiring IV/oral steroids or immunosuppressive or immunomodulatory therapies.
- (e.g., type 1 juvenile onset diabetes mellitus, antibody positive for rheumatoid arthritis, Graves disease, Hashimoto thyroiditis, lupus, scleroderma, systemic vasculitis, hemolytic anemia, immune mediated thrombocytopenia, Crohn disease, ulcerative colitis, and psoriasis).
Show all 21Show fewer
- Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Grade 0 or 1 (using National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0), except for alopecia and laboratory values listed in the inclusion criteria.
- A history of other malignancies (except non-melanoma skin carcinoma, carcinoma in situ of the uterine cervix, follicular or papillary thyroid cancer) within 5 years.
- Patient with any known uncontrolled comorbid illness including ongoing or active infections, symptomatic congestive heart failure (NYHA>2), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Treatment with any of the following therapies within 4 weeks prior to the first dose of OBI-833/OBI-821:
- Anti-cancer therapies, including chemotherapy and targeted therapy (except the GemCis regimen).
- Radiotherapy.
- Immunotherapy, including monoclonal antibodies, cytokines, interferons, and checkpoint inhibitors.
- Immunosuppressants, including cyclosporin, rapamycin, tacrolimus, rituximab, alemtuzumab, natalizumab, and cyclophosphamide.
- Other biologics, including G-CSF and other hematopoietic growth factors.
- Live attenuated vaccines.
- IV/oral steroids except single prophylactic use in CT/MRI scan or other one-time use in approved indications. Use of inhaled and topical (except on the injection site) steroids is allowed.
- Alternative and complementary medicine that may affect the immune system.
- Other investigational drugs.
- Patient with any known severe allergies (e.g., anaphylaxis) to any active or inactive ingredients in the study drugs.
- Any other reason that the investigator deems the patient to be unsuitable for the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Wen-Kuan Huang, PhD contact
Taiwan2 sites
Chang Gung Memorial Hospital Linkou Branch
Taoyuan, 333
Chang-Gung Memorial Hospital, Linkou Branch
Taoyuan
About this study
Official title: A Single-Arm, Phase 2 Study to Evaluate OBI-833/OBI-821 Maintenance Therapy in Patients With Globo H-Positive Advanced Biliary Tract Cancer Not Progresseding Under First-Line Gemcitabine and Cisplatin
A Phase 2 clinical trial protocol for evaluating the efficacy and safety of OBI-833/OBI-821, a carbohydrate-conjugate vaccine combined with an immune adjuvant, as maintenance therapy in combination with first-line gemcitabine and cisplatin chemotherapy for patients with Globo H-positive advanced biliary tract cancer. The study is designed as a single-arm trial with 30 patients who have achieved stable disease, partial response, or complete response after 3±1 months of initial chemotherapy. The primary endpoint is progression-free survival, with secondary endpoints including overall survival, tumor response, and safety profile. The treatment regimen involves subcutaneous injections of OBI-833/OBI-821 on a gradually decreasing frequency schedule for up to 80 weeks. The trial also includes exploratory objectives to assess immune responses and biomarkers. This study aims to address the unmet need for improved treatment options in advanced biliary tract cancer by leveraging the potential of immunotherapy targeting the Globo H antigen.
Read the detailed description
This clinical trial is a single-arm, phase 2 study evaluating OBI-833/OBI-821 as maintenance therapy in patients with Globo H-positive advanced biliary tract cancer who have not progressed on first-line gemcitabine and cisplatin chemotherapy. The study is grounded in the challenging prognosis of biliary tract cancer, including cholangiocarcinoma, which has limited treatment options. Currently, the standard first-line therapy is gemcitabine plus cisplatin, but progression-free survival remains short at around 6 months, highlighting the need for improved treatment strategies.
The investigational therapy, OBI-833, is a glycoconjugate vaccine targeting Globo H, a tumor-associated carbohydrate antigen expressed in many epithelial cancers. It is used in combination with OBI-821, an adjuvant designed to enhance the immune response. Previous studies have demonstrated that OBI-833/OBI-821 can elicit immune responses and provide disease stabilization in some cancer patients. Notably, Globo H expression has been detected in about 41% of intrahepatic cholangiocarcinoma specimens, providing a rationale for investigating this approach in biliary tract cancer.
The study design involves enrolling 30 patients in a single-arm trial. Eligible patients must have Globo H-positive advanced biliary tract cancer that has not progressed after 3±1 months of first-line gemcitabine/cisplatin therapy. Patients will receive OBI-833/OBI-821 subcutaneously on a gradually decreasing frequency schedule for up to 80 weeks, while continuing their gemcitabine/cisplatin regimen. The primary endpoint of the study is progression-free survival, with secondary endpoints including overall survival, tumor response, safety, and correlations between Globo H expression/antibodies and survival outcomes.
To ensure safety, the study incorporates a lead-in safety cohort of 6 patients before proceeding to full enrollment. Following the treatment period, patients will be followed for survival for up to 12 months after the end of treatment. This single-arm design allows for an efficient assessment of efficacy signals that could inform potential further development of this therapeutic approach.
The overall aim of the study is to evaluate whether adding OBI-833/OBI-821 maintenance therapy can prolong disease control in this patient population with high unmet medical need. By focusing on patients with Globo H-positive tumors who have initially responded to standard chemotherapy, the study seeks to explore a potentially targeted approach to maintaining and extending the benefits of first-line treatment in advanced biliary tract cancer.
- Conditions
- Cholangiocarcinoma, Chemotherapy Effect, Immunotherapy
- Being tested
- OBI-833/OBI-821
- Keywords
- Cholangiocarcinoma, Immunotherapy, Chemotherapy, Globo-H
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBI-833/OBI-821Drug
Also called Globo H-CRM197
OBI-833 is a glycoconjugate that consists of Globo H, a unique tumor-associated carbohydrate antigen (TACA), covalently linked to cross-reacting material 197 (CRM197), an inactive and nontoxic form of diphtheria toxin (DT) acting as the carrier protein.
OBI-821 is a saponin-based adjuvant derived from the bark of the Quillaja saponaria Molina tree. It is a purified saponin adjuvant structurally similar to adjuvant QS-21. The OBI-833/OBI-821 combination represents a carbohydrate-conjugate vaccine combined with an immune adjuvant, intended to serve as an active cancer immunotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Globo-H | Experimental | OBI-833, 30 μg/ OBI-821 100 μg, Subcutaneous injection at Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48, 56, 64, 72, and 80 weeks Receives: Drug: OBI-833/OBI-821 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The time from start of treatment until disease progression or death from any cause
Measured: 12 to 18 months of subject recruitment, 80 weeks of OBI-833/OBI-821 treatment, and another 1 year for overall survival follow-up.
Secondary outcomes (4)
Overall survival
The time from start of treatment until death from any cause
Measured: 12 to 18 months of subject recruitment, 80 weeks of OBI-833/OBI-821 treatment, and another 1 year for overall survival follow-up.
Best overall tumor response
by RECIST 1.1 criteria
Measured: 12 to 18 months of subject recruitment, 80 weeks of OBI-833/OBI-821 treatment, and another 1 year for overall survival follow-up.
Adverse events
Incidences of adverse events and serious adverse events, Local injection site reaction, Changes in laboratory tests, including hematology and serum chemistry, Changes in vital signs, Changes in physical examination
Measured: 12 to 18 months of subject recruitment, 80 weeks of OBI-833/OBI-821 treatment, and another 1 year for overall survival follow-up.
Correlation between anti-Globo H IgM and IgG concentrations and survival
biomarker response and survival correlation analysis
Measured: 12 to 18 months of subject recruitment, 80 weeks of OBI-833/OBI-821 treatment, and another 1 year for overall survival follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start31 Jul 2024 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeh Chun-Nan, Chang Gung Memorial Hospital
- Investigators
- Chun-Nan Yeh, Principal investigator, Department of Surgery, Chang Gung Memorial Hospital, Linkou, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490198
- Sponsor's protocol ID
- 202400601A0C601
- Status last verified
- Jun 2024
- First submitted
- 30 Jun 2024
- Last updated
- 8 Jul 2024
- 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Phase 2 Study to Evaluate OBI-833/OBI-821 Maintenance Therapy in Patients With Globo H-Positive Advanced Biliary Tract Cancer Not Progresseding Under First-Line Gemcitabine and Cisplatin
- ClinicalTrials.gov ID
- NCT06490198
- Acronym / sponsor ID
- 202400601A0C601
- Conditions
- Cholangiocarcinoma, Chemotherapy Effect, Immunotherapy
- Keywords
- Cholangiocarcinoma, Immunotherapy, Chemotherapy, Globo-H
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 31 Jul 2024 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 8 Jul 2024 (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.
A Phase 2 clinical trial protocol for evaluating the efficacy and safety of OBI-833/OBI-821, a carbohydrate-conjugate vaccine combined with an immune adjuvant, as maintenance therapy in combination with first-line gemcitabine and cisplatin chemotherapy for patients with Globo H-positive advanced biliary tract cancer. The study is designed as a single-arm trial with 30 patients who have achieved stable disease, partial response, or complete response after 3±1 months of initial chemotherapy. The primary endpoint is progression-free survival, with secondary endpoints including overall survival, tumor response, and safety profile. The treatment regimen involves subcutaneous injections of OBI-833/OBI-821 on a gradually decreasing frequency schedule for up to 80 weeks. The trial also includes exploratory objectives to assess immune responses and biomarkers. This study aims to address the unmet need for improved treatment options in advanced biliary tract cancer by leveraging the potential of immunotherapy targeting the Globo H antigen.
Detailed description
This clinical trial is a single-arm, phase 2 study evaluating OBI-833/OBI-821 as maintenance therapy in patients with Globo H-positive advanced biliary tract cancer who have not progressed on first-line gemcitabine and cisplatin chemotherapy. The study is grounded in the challenging prognosis of biliary tract cancer, including cholangiocarcinoma, which has limited treatment options. Currently, the standard first-line therapy is gemcitabine plus cisplatin, but progression-free survival remains short at around 6 months, highlighting the need for improved treatment strategies.
The investigational therapy, OBI-833, is a glycoconjugate vaccine targeting Globo H, a tumor-associated carbohydrate antigen expressed in many epithelial cancers. It is used in combination with OBI-821, an adjuvant designed to enhance the immune response. Previous studies have demonstrated that OBI-833/OBI-821 can elicit immune responses and provide disease stabilization in some cancer patients. Notably, Globo H expression has been detected in about 41% of intrahepatic cholangiocarcinoma specimens, providing a rationale for investigating this approach in biliary tract cancer.
The study design involves enrolling 30 patients in a single-arm trial. Eligible patients must have Globo H-positive advanced biliary tract cancer that has not progressed after 3±1 months of first-line gemcitabine/cisplatin therapy. Patients will receive OBI-833/OBI-821 subcutaneously on a gradually decreasing frequency schedule for up to 80 weeks, while continuing their gemcitabine/cisplatin regimen. The primary endpoint of the study is progression-free survival, with secondary endpoints including overall survival, tumor response, safety, and correlations between Globo H expression/antibodies and survival outcomes.
To ensure safety, the study incorporates a lead-in safety cohort of 6 patients before proceeding to full enrollment. Following the treatment period, patients will be followed for survival for up to 12 months after the end of treatment. This single-arm design allows for an efficient assessment of efficacy signals that could inform potential further development of this therapeutic approach.
The overall aim of the study is to evaluate whether adding OBI-833/OBI-821 maintenance therapy can prolong disease control in this patient population with high unmet medical need. By focusing on patients with Globo H-positive tumors who have initially responded to standard chemotherapy, the study seeks to explore a potentially targeted approach to maintaining and extending the benefits of first-line treatment in advanced biliary tract cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Globo-H | Experimental | Drug: OBI-833/OBI-821OBI-833, 30 μg/ OBI-821 100 μg, Subcutaneous injection at Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48, 56, 64, 72, and 80 weeks |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Aged ≥ 20 years.
- Histologically confirmed, unresectable advanced or metastatic biliary tract cancer, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
- Patient with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
- Patient with recurrent disease >6 months after curative surgery or >6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.
- Patient must have a documented Globo H H-score of at least 80 using a validated central IHC assay.
Key exclusion criteria (21 listed)
- Patient who has CNS metastasis or spinal cord compression.
- Patient who is pregnant or breast-feeding at entry.
- Patient with splenectomy.
- Patient with HIV infection, active hepatitis B infection, or active hepatitis C infection. Patients with hepatitis B infection under anti-HBV medications are exceptionalcan be included in the study. Patients with hepatitis C infection history but inactive status are exceptionalcan be included in the study.
- Patient with any autoimmune or other disorders requiring IV/oral steroids or immunosuppressive or immunomodulatory therapies.
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 |
|---|---|---|
| OBI-833/OBI-821Also: Globo H-CRM197OBI-833 is a glycoconjugate that consists of Globo H, a unique tumor-associated carbohydrate antigen (TACA), covalently linked to cross-reacting material 197 (CRM197), an inactive and nontoxic form of diphtheria toxin (DT) acting as the carrier protein. OBI-821 is a saponin-based adjuvant derived from the bark of the Quillaja saponaria Molina tree. It is a purified saponin adjuvant structurally similar to adjuvant QS-21. The OBI-833/OBI-821 combination represents a carbohydrate-conjugate vaccine combined with an immune adjuvant, intended to serve as an active cancer immunotherapy. | Drug | Globo-H |
Primary outcome
Progression-free survival
Time frame: 12 to 18 months of subject recruitment, 80 weeks of OBI-833/OBI-821 treatment, and another 1 year for overall survival follow-up.
The time from start of treatment until disease progression or death from any cause
4 secondary outcomes
Overall survival
Time frame: 12 to 18 months of subject recruitment, 80 weeks of OBI-833/OBI-821 treatment, and another 1 year for overall survival follow-up.
Best overall tumor response
Time frame: 12 to 18 months of subject recruitment, 80 weeks of OBI-833/OBI-821 treatment, and another 1 year for overall survival follow-up.
Adverse events
Time frame: 12 to 18 months of subject recruitment, 80 weeks of OBI-833/OBI-821 treatment, and another 1 year for overall survival follow-up.
Correlation between anti-Globo H IgM and IgG concentrations and survival
Time frame: 12 to 18 months of subject recruitment, 80 weeks of OBI-833/OBI-821 treatment, and another 1 year for overall survival follow-up.
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 8 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Cholangiocarcinoma
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 1
A Study of LY4337713 in Participants With FAP-Positive Solid Tumors
Ovarian Neoplasms, Breast Neoplasms
RecruitingPhase 3
D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer
Biliary Tract Cancer (BTC)
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
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.
Wen-Kuan Huang, PhD contact
Chun-Nan Yeh principal investigator
Department of Surgery, Chang Gung Memorial Hospital, Linkou, Taiwan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OBI-833/OBI-821 in people with Cholangiocarcinoma and Chemotherapy Effect, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
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 13 inclusion and 21 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 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Chun-Nan Yeh, MD (886-33281200, yehchunnan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 12 to 18 months of subject recruitment, 80 weeks of OBI-833/OBI-821 treatment, and another 1 year for overall survival follow-up.). 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 8 Jul 2024.