Gastrointestinal TumorsPhase 2ALTER-G-001NCT05262335
Anlotinib Plus Chemotherapy as First-line Therapy for Gastrointestinal Tumor Patients With Unresectable Liver Metastasis (ALTER-G-001)
A Phase 2 study testing Anlotinib + Oxaliplatin + Capecitabine, Anlotinib + Cisplatin + Paclitaxel/ Docetaxel and Anlotinib + Standard first-line chemotherapy in people with Gastrointestinal Tumors, run by Ruijin Hospital at 7 sites in China.
Trial summary
This is an open, multi-cohort, multi-center, exploratory and phase II clinical trial. To evaluate the efficacy and safety Anlotinib combined with chemotherapy as first-line and maintenance therapy for Gastrointestinal Tumors with Unresectable Liver Metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Tumors
- What is being tested?
- Anlotinib + Oxaliplatin + Capecitabine, Anlotinib + Cisplatin + Paclitaxel/ Docetaxel and Anlotinib + Standard first-line chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 7 sitesChina
- Study dates
- 1 Dec 2021to 1 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 or cytologically confirmed Ⅳ phase of colorectal cancer with liver metastases (TanyNanyM1), and the liver metastases are unresectable; Or Histologically or cytologically confirmed Ⅳb phase of esophageal squamous cell carcinoma with liver metastases (TanyNanyM1) (excluding mixed type adenosquamous carcinoma), and the liver metastases are unresectable; Or Histologically or cytologically confirmed other gastrointestinal tumors with liver metastases (excluding gastrointestinal stromal tumors, neuroendocrine tumors and other malignant tumors of non-glandular epithelial origin), and the liver metastases are unresectable;
- No previous systemic treatment, including chemotherapy, targeted and immunotherapy;
- The target lesion must contain liver metastases. According to RECIST version 1.1, liver metastases have at least one measurable focus;
- Age from 18-75 years old;
- ECOG performance status of 0-1;
- Life expectancy of at least 3 months;
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- The main organs are functioning normally (normal main organs function as defined below: Hemoglobin (Hb) ≥ 90 g/L, Neutrophils (ANC) ≥ 1.5×109/L, Platelet count (PLT) ≥ 90×109/L, Total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 5 ×ULN, Creatinine Clearance rate (CCr) ≥60ml/min)
- Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 3 months after study is stopped；the result of serum or urine pregnancy test should be negative before enrollment；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 2 months after study is stopped.
- Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.
Who cannot join
- Patients with active bleeding within 2 months of primary and/or metastatic lesions;
- Patients with previous arterial/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attack), deep venous thrombosis or pulmonary embolism;
- Patients who are receiving thrombolytic or anticoagulant therapies such as warfarin, heparin, or their analogists; allowed to take low-dose heparin (6000 to 12,000 U/d for adults) or low-dose aspirin (≤100 mg/d) for prophylactic purposes with an INR≤1.5×ULN;
- Gastrointestinal diseases with a bleeding tendency (such as active gastrointestinal ulcer) or be likely to cause gastrointestinal bleeding, perforation, or obstruction, or patients with fistula;
- Have undergone major surgery (craniotomy, thoracotomy or open surgery) within 4 weeks prior to the first dose study;
- HER2-positive gastric adenocarcinoma;
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- A history of immunodeficiency, including a positive HIV test or other acquired, congenital immunodeficiency disease, or a history of organ transplantation;
- A variety of factors affecting oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
- Symptomatic central nervous system metastasis and/or cancerous meningitis are known to exist;
- Patients with any severe and / or uncontrolled disease, including: Patients with hypertension that cannot be well controlled by single antihypertensive therapy (SBP ≥150 mmHg, Diastolic BP ≥100mmHg); Or taking two or more antihypertensive drugs to control blood pressure; Acute myocardial infarction, malignant arrhythmias (including QT interval > 450ms in men and > 470ms in women) and ≥2 grade congestive heart failure (NYHA grade); Active or uncontrolled severe infection (NCI-CTC AE grade ≥2 infection); Liver diseases such as cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis (HBV-DNA > 1000 IU/mL) require antiviral therapy; Diabetic patients with poor blood glucose control (fasting blood glucose (FBG) > 10 mmol/L); Routine urine indicated urine protein ≥ ++, and confirmed 24-hour urine protein quantitative > 1.0 g;
- Clinically significant ascites, including any ascites that can be found on a physical examination, ascites that has been treated or currently in need of treatment, and only those with a small amount of ascites but no symptoms can be selected;
- A moderate amount of fluid in both sides of the chest, or a large amount of fluid in one side of the chest, or has caused respiratory dysfunction Patient to be drained;
- Uncontrolled metabolic disorders or other non-malignant organs or secondary reactions to systemic diseases or cancers that may lead to higher medical risk and/or uncertainty in survival evaluation;
- Known to have active tuberculosis;
- Suffering from interstitial lung disease requiring steroid therapy;
- Significantly malnourished patients;
- Those who have a history of psychotropic substance abuse and are unable to quit or have a mental disorder;
- Known to be allergic to the test drug;
- Participated in clinical trials of other anti-tumor therapies within 4 weeks;
- Pregnant or lactating women.;
- History of other primary malignancies, but the following: 1) complete remission of malignant tumors for at least 2 years prior to enrollment and no additional treatment during the study; 2) non-melanoma skin cancer or malignant freckle-like sputum with adequate treatment and no evidence of disease recurrence; 3) adequately treated and In situ carcinoma without evidence of disease recurrence;
- According to the investigator's judgment, there are serious concomitant diseases that endanger the safety of the patient or affect the patient's completion of the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Not yet recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu
Liangjun Zhu, MD & Ph. D
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
Lingjun Zhu, MD & Ph. D
- Recruiting
Jiading Cental Hospital Shanghai University of Medicine & Health Sciences
Shanghai
Jun Yan, MD & Ph. D
- Recruiting
Ruijin Hospital
Shanghai
Jun Zhang, Ph. D, +86-21-64370045, junzhang10977@sjtu.edu.cn
- Not yet recruiting
Tongji Hospital of Tongji University
Shanghai
Hong Jiang, MD & Ph. D
- Not yet recruiting
Affiliated Hospital of Jiannan University
Wuxi, Jiangsu
Yong Mao, MD & Ph. D
- Recruiting
Wuxi Branch of Rujin Hospital
Wuxi, Jiangsu
Xinyu Tang, MD & Ph. D
About this study
Official title: Anlotinib Plus Chemotherapy as First-line Therapy for Gastrointestinal Tumor Patients With Unresectable Liver Metastasis: A Multi-cohort, Multi-center Clinical Trial (ALTER-G-001)
This is an open, multi-cohort, multi-center, exploratory and phase II clinical trial. To evaluate the efficacy and safety Anlotinib combined with chemotherapy as first-line and maintenance therapy for Gastrointestinal Tumors with Unresectable Liver Metastases.
- Conditions
- Gastrointestinal Tumors
- Being tested
- Anlotinib + Oxaliplatin + Capecitabine, Anlotinib + Cisplatin + Paclitaxel/ Docetaxel, Anlotinib + Standard first-line chemotherapy
- Medical subject headings
- Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib + Oxaliplatin + CapecitabineDrug
- Before 6 cycles, Anlotinib 12mg, po.qd, d1-14; Capecitabine 850 mg/m2, po. bid, d1-14; Oxaliplatin 130 mg/m2, iv (D1). The above schemes are repeated every three weeks.
- After 6 cycles, the regimen is changed to Anlotinib (12mg, po.qd, d1-14)+ Capecitabine (500 mg, po. bid, d1-21). The regimen is repeated every 3 weeks until the disease progresses or unacceptable toxicity.
Anlotinib + Cisplatin + Paclitaxel/ DocetaxelDrug
- Anlotinib 12mg, po.qd, d1-14; Cisplatin 60-75mg/m2, iv, d1/d1-d3; Paclitaxel 135mg/m2, iv (D1). or Docetaxel 75mg/m2, iv (D1). The above schemes are repeated every three weeks.
- After 6 cycles, the regimen is changed to Anlotinib (12mg, po.qd, d1-14)+ Capecitabine (500 mg, po. bid, d1-21). The regimen is repeated every 3 weeks until the disease progresses or unacceptable toxicity.
Anlotinib + Standard first-line chemotherapyDrug
- Anlotinib 12mg, po.qd, d1-14; Standard first-line chemotherapy determined by the researchers. The above schemes are repeated every three weeks.
- After 6 cycles, the regimen is changed to Anlotinib (12mg, po.qd, d1-14)+ Capecitabine (500 mg, po. bid, d1-21). The regimen is repeated every 3 weeks until the disease progresses or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Experimental group 1 | Experimental | Initial treatment: Anlotinib + Oxaliplatin + Capecitabine. Maintenance treatment (after 6 cycles): Anlotinib + Capecitabine Receives: Drug: Anlotinib + Oxaliplatin + Capecitabine |
| Experimental: Experimental group 2 | Experimental | Initial treatment: Anlotinib + Cisplatin + Paclitaxel/ Docetaxel. Maintenance treatment (after 6 cycles): Anlotinib + Capecitabine Receives: Drug: Anlotinib + Cisplatin + Paclitaxel/ Docetaxel |
| Experimental: Experimental group 3 | Experimental | Initial treatment: Anlotinib + Standard first-line chemotherapy Maintenance treatment (after 6 cycles): Anlotinib + Capecitabine Receives: Drug: Anlotinib + Standard first-line chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective response rate is defined as the percentage of subjects whose best response was complete response (CR) or partial response (PR) according to the RECIST v1.1.
Measured: up to 24 months
Secondary outcomes (6)
Progression-free survival (PFS)
Progression-free survival is defined as the time from enrollment to the date of first document disease progression or death from any cause.
Measured: up to 24 months
Disease Control Rate (DCR)
Disease control rate is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the RECIST v1.1.
Measured: up to 24 months
Duration of Response (DoR)
Duration of Response is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the RECIST v1.1 or death due to any cause, whichever occurs first.
Measured: up to 24 months
Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Adverse events assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).
Measured: Until 30 day safety follow-up visit
Overall Survival (OS)
Overall Survival (OS) is defined as the time from enrollment to death from any cause.
Measured: Up to 24 months
Radical Resection Rate of Liver Metastases
Radical Resection Rate of Liver Metastases is defined as the percentage of subjects whose liver metastases from unresectable to resectable.
Measured: Up to 6 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Dec 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal TumorsStudies of the same condition, open and under way.
- More trials run by Ruijin 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262335
- Sponsor's protocol ID
- 2021223
- Acronym
- ALTER-G-001
- Status last verified
- Feb 2023
- First submitted
- 21 Feb 2022
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu JW, Zhou CF, Han ZX, Zhang H, Yan J, Chen J, Wang CB, Qin ZQ, Mao Y, Tang XY, Zhu LJ, Wei XW, Cui DH, Yang XL, Shi M, Zhao LQ, Jiang JL, Zhu WY, Wang HM, Wang C, Zhu LJ, Zhang J. Anlotinib plus chemotherapy as a first-line treatment for gastrointestinal cancer patients with unresectable liver metastases: a multicohort, multicenter, exploratory trial. Signal Transduct Target Ther. 2024 Dec 9;9(1):344. doi: 10.1038/s41392-024-02051-4.
PubMed 39648217Li H, Feng H, Zhang T, Wu J, Shen X, Xu S, Xu L, Wang S, Zhang Y, Jia W, Ji X, Cheng X, Zhao R. CircHAS2 activates CCNE2 to promote cell proliferation and sensitizes the response of colorectal cancer to anlotinib. Mol Cancer. 2024 Mar 21;23(1):59. doi: 10.1186/s12943-024-01971-7.
PubMed 38515149
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anlotinib Plus Chemotherapy as First-line Therapy for Gastrointestinal Tumor Patients With Unresectable Liver Metastasis: A Multi-cohort, Multi-center Clinical Trial (ALTER-G-001)
- ClinicalTrials.gov ID
- NCT05262335
- Acronym / sponsor ID
- ALTER-G-001 / 2021223
- Conditions
- Gastrointestinal Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 2 Mar 2022 (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 is an open, multi-cohort, multi-center, exploratory and phase II clinical trial. To evaluate the efficacy and safety Anlotinib combined with chemotherapy as first-line and maintenance therapy for Gastrointestinal Tumors with Unresectable Liver Metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Experimental group 1 | Experimental | Drug: Anlotinib + Oxaliplatin + CapecitabineInitial treatment: Anlotinib + Oxaliplatin + Capecitabine. Maintenance treatment (after 6 cycles): Anlotinib + Capecitabine |
| Experimental: Experimental group 2 | Experimental | Drug: Anlotinib + Cisplatin + Paclitaxel/ DocetaxelInitial treatment: Anlotinib + Cisplatin + Paclitaxel/ Docetaxel. Maintenance treatment (after 6 cycles): Anlotinib + Capecitabine |
| Experimental: Experimental group 3 | Experimental | Drug: Anlotinib + Standard first-line chemotherapyInitial treatment: Anlotinib + Standard first-line chemotherapy Maintenance treatment (after 6 cycles): Anlotinib + Capecitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically or cytologically confirmed Ⅳ phase of colorectal cancer with liver metastases (TanyNanyM1), and the liver metastases are unresectable; Or Histologically or cytologically confirmed Ⅳb phase of esophageal squamous cell carcinoma with liver metastases (TanyNanyM1) (excluding mixed type adenosquamous carcinoma), and the liver metastases are unresectable; Or Histologically or cytologically confirmed other gastrointestinal tumors with liver metastases (excluding gastrointestinal stromal tumors, neuroendocrine tumors and other malignant tumors of non-glandular epithelial origin), and the liver metastases are unresectable;
- No previous systemic treatment, including chemotherapy, targeted and immunotherapy;
- The target lesion must contain liver metastases. According to RECIST version 1.1, liver metastases have at least one measurable focus;
- Age from 18-75 years old;
- ECOG performance status of 0-1;
Key exclusion criteria (22 listed)
- Patients with active bleeding within 2 months of primary and/or metastatic lesions;
- Patients with previous arterial/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attack), deep venous thrombosis or pulmonary embolism;
- Patients who are receiving thrombolytic or anticoagulant therapies such as warfarin, heparin, or their analogists; allowed to take low-dose heparin (6000 to 12,000 U/d for adults) or low-dose aspirin (≤100 mg/d) for prophylactic purposes with an INR≤1.5×ULN;
- Gastrointestinal diseases with a bleeding tendency (such as active gastrointestinal ulcer) or be likely to cause gastrointestinal bleeding, perforation, or obstruction, or patients with fistula;
- Have undergone major surgery (craniotomy, thoracotomy or open surgery) within 4 weeks prior to the first dose study;
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 |
|---|---|---|
| Anlotinib + Oxaliplatin + Capecitabine1. Before 6 cycles, Anlotinib 12mg, po.qd, d1-14; Capecitabine 850 mg/m2, po. bid, d1-14; Oxaliplatin 130 mg/m2, iv (D1). The above schemes are repeated every three weeks. 2. After 6 cycles, the regimen is changed to Anlotinib (12mg, po.qd, d1-14)+ Capecitabine (500 mg, po. bid, d1-21). The regimen is repeated every 3 weeks until the disease progresses or unacceptable toxicity. | Drug | Experimental: Experimental group 1 |
| Anlotinib + Cisplatin + Paclitaxel/ Docetaxel1. Anlotinib 12mg, po.qd, d1-14; Cisplatin 60-75mg/m2, iv, d1/d1-d3; Paclitaxel 135mg/m2, iv (D1). or Docetaxel 75mg/m2, iv (D1). The above schemes are repeated every three weeks. 2. After 6 cycles, the regimen is changed to Anlotinib (12mg, po.qd, d1-14)+ Capecitabine (500 mg, po. bid, d1-21). The regimen is repeated every 3 weeks until the disease progresses or unacceptable toxicity. | Drug | Experimental: Experimental group 2 |
| Anlotinib + Standard first-line chemotherapy1. Anlotinib 12mg, po.qd, d1-14; Standard first-line chemotherapy determined by the researchers. The above schemes are repeated every three weeks. 2. After 6 cycles, the regimen is changed to Anlotinib (12mg, po.qd, d1-14)+ Capecitabine (500 mg, po. bid, d1-21). The regimen is repeated every 3 weeks until the disease progresses or unacceptable toxicity. | Drug | Experimental: Experimental group 3 |
Primary outcome
Objective response rate (ORR)
Time frame: up to 24 months
Objective response rate is defined as the percentage of subjects whose best response was complete response (CR) or partial response (PR) according to the RECIST v1.1.
6 secondary outcomes
Progression-free survival (PFS)
Time frame: up to 24 months
Disease Control Rate (DCR)
Time frame: up to 24 months
Duration of Response (DoR)
Time frame: up to 24 months
Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Until 30 day safety follow-up visit
Overall Survival (OS)
Time frame: Up to 24 months
Radical Resection Rate of Liver Metastases
Time frame: Up to 6 cycles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 39648217Wu JW, Zhou CF, Han ZX, Zhang H, Yan J, Chen J, Wang CB, Qin ZQ, Mao Y, Tang XY, Zhu LJ, Wei XW, Cui DH, Yang XL, Shi M, Zhao LQ, Jiang JL, Zhu WY, Wang HM, Wang C, Zhu LJ, Zhang J. Anlotinib plus chemotherapy as a first-line treatment for gastrointestinal cancer patients with unresectable liver metastases: a multicohort, multicenter, exploratory trial. Signal Transduct Target Ther. 2024 Dec 9;9(1):344. doi: 10.1038/s41392-024-02051-4.
- Derived from this study: PubMed 38515149Li H, Feng H, Zhang T, Wu J, Shen X, Xu S, Xu L, Wang S, Zhang Y, Jia W, Ji X, Cheng X, Zhao R. CircHAS2 activates CCNE2 to promote cell proliferation and sensitizes the response of colorectal cancer to anlotinib. Mol Cancer. 2024 Mar 21;23(1):59. doi: 10.1186/s12943-024-01971-7.
- 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. This study is not recruiting at the moment.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib + Oxaliplatin + Capecitabine, Anlotinib + Cisplatin + Paclitaxel/ Docetaxel and Anlotinib + Standard first-line chemotherapy in people with Gastrointestinal Tumors, run by Ruijin Hospital at 7 sites 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 9 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Zhang, Ph. D (+86-21-64370045, junzhang10977@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05262335, which also lists 2 linked publications.
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 28 Nov 2023.