Hepatocellular Carcinoma Non-ResectableEarly Phase 1NCT07746960

Chemotherapy With the Ralox Regimen Combined With Anlotinib and Penpulimab for Unresectable Hepatocellular Carcinoma

A Early Phase 1 study testing Intravenous chemotherapy with the Ralox regimen combined with Anlotinib and Penpulimab in people with Hepatocellular Carcinoma Non-Resectable, run by Nanfang Hospital, Southern Medical University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The objective of this clinical trial study is to determine whether intravenous chemotherapy with the Ralox regimen in combination with Anlotinib and Penpulimab has certain efficacy and high safety for patients with unresectable hepatocellular carcinoma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatocellular Carcinoma Non-Resectable
What is being tested?: Intravenous chemotherapy with the Ralox regimen combined with Anlotinib and Penpulimab
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteChina
Study dates: 1 Jan 2025to 31 Dec 2027
Phase: Early 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult males or females;
Meeting the relevant criteria in the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)", and diagnosed with HCC through examinations such as ultrasound, enhanced CT and, magnetic resonance imaging, liver puncture biopsy;
Patients with unresectable HCC (patients with recurrence after radical resection are eligible for enrollment);
ECOG PS score ≤ 2;
Liver function of Child-Pugh class A/B, and liver function reserve ICG ≤ 30%;
According to the mRECIST criteria for tumor assessment, having ≥ 1 measurable intrahepatic target lesion, and the estimated survival period ≥ 6 months;
Normal organ and bone marrow functions before randomization, including: hemoglobin ≥ 90 g/L, absolute neutrophil count ≥ 1.0 × 10^9/L, platelet count ≥ 75 × 10^9/L, total bilirubin ≤ 2.0 × the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN, albumin ≥ 28 g/L, international normalized ratio PT-INR ≤ 1.6, glomerular filtration rate (DCK-EPI formula) ≥ 50 mL/min, urine protein < 2+ or 24 - hour urine protein quantification < 1.0 g;
Those who voluntarily sign the informed consent form.

Who cannot join

Patients with obvious abnormalities in organ and bone marrow functions that are difficult to reverse before randomization, including: hemoglobin < 90 g/L, absolute neutrophil count < 1.0 × 10^9/L, platelet count < 75 × 10^9/L, total bilirubin > 2.0 × the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 5 × ULN, albumin < 28 g/L, international normalized ratio PT - INR > 1.6, glomerular filtration rate (CKD - EPI formula) < 30 mL/min, urine protein ≥ 2+ or 24 - hour urine protein quantification ≥ 1.0 g.
Patients with infection, bleeding tendency, massive ascites and hepatic encephalopathy.
Patients who have been using hepatotoxic drugs for a long - term due to their own diseases and cannot stop taking the drugs.
Patients who have previously received chemotherapy, radiotherapy, immunotherapy or targeted therapy.
Patients with other severe diseases of the heart, brain, kidneys and other organs, autoimmune diseases, or diseases such as HIV/tuberculosis that the researcher deems inappropriate for enrollment.
Patients who fail to complete the treatment cycle before tumor assessment after the first treatment.
Patients with incomplete clinical general data or imaging data.
Patients who are currently participating in other therapeutic studies.

Trial locations and contacts

1 site in 1 country.

China1 site

Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515

Other trials in China

About this study

Official title: A Single-center Exploratory Clinical Study of Chemotherapy With the Ralox Regimen Combined With Anlotinib and Penpulimab for Unresectable Hepatocellular Carcinoma

Overall design: This clinical study is a single - center, single - arm, prospective clinical study.

In this single - arm study, randomization grouping is not involved. Sample size estimation: According to previous research reports, the objective response rate (ORR0) of targeted immunotherapy for literature unresectable HCC is 30%. If α = 0.05 and 1 - β = 0.80 are set, and assuming that the ORR1 of systemic chemotherapy combined with targeted immunotherapy for unresectable HCC is 59.2%, at least 21 patients need to be enrolled as calculated by the PASS15.0 software. Considering a 10% dropout rate, 24 patients need to be enrolled. It is planned to enroll a total of 30 patients.

Subjects will receive systemic intravenous chemotherapy combined with immune checkpoint inhibitors and targeted drug therapy:

The intravenous chemotherapy regimen is as follows: Oxaliplatin 100 mg/m², intravenous infusion for 3 hours on Day 1, once every 3 weeks; Raltitrexed 3 mg/m², intravenous infusion for 15 minutes on Day 1.

Penpulimab 200 mg, once every 3 weeks. Anlotinib 12 mg, taken orally once a day, with 2 weeks of administration followed by 1 week of discontinuation.

Each cycle is 21 days. The combined medication will be continued for 3 cycles, or until obvious disease progression, patient intolerance, or until the researcher deems it necessary to stop the medication (whichever occurs first). After that, subsequent treatment will be carried out according to the clinical diagnosis and treatment routine based on the tumor situation.

For each subject, safety assessment and research compliance assessment will be conducted at the first dose and at Weeks 1, 2, and 3 of treatment, and the researcher will medication provide guidance. An examination will be conducted once at the screening visit, every 6 weeks during the treatment phase, and at each research visit during the follow - up period. Throughout the entire research process, its toxicity and safety will be monitored.

Conditions: Hepatocellular Carcinoma Non-Resectable
Being tested: Intravenous chemotherapy with the Ralox regimen combined with Anlotinib and Penpulimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intravenous chemotherapy with the Ralox regimen combined with Anlotinib and PenpulimabDrug
The intravenous chemotherapy regimen is as follows: Oxaliplatin 100 mg/m², intravenous infusion for 3 hours on Day 1, once every 3 weeks; Raltitrexed 3 mg/m², intravenous infusion for 15 minutes on Day 1.
Penpulimab 200 mg, once every 3 weeks. Anlotinib 12 mg, taken orally once a day, with 2 weeks of administration followed by 1 week of discontinuation

Study groups in NCT07746960
Study group	Role	What they receive
Group of patients with unresectable hepatocellular carcinoma	Experimental	Not described Receives: Drug: Intravenous chemotherapy with the Ralox regimen combined with Anlotinib and Penpulimab

What is being measured

The primary outcome is the main question the study is designed to answer.

ORR
ORR = (Number of CR cases + Number of PR cases) / Total number of cases
Measured: through study completion.Continuously follow up the patient's subsequent treatment and survival status，an average of 1 year

Secondary outcomes (3)

Conduct imaging evaluation
Perform imaging examinations such as enhanced CT/MRI of the upper abdomen and plain CT of the chest.
Complete response (CR): All the arterial-phase enhanced imaging of target lesions disappears; Partial response (PR): The sum of the maximum diameters of target lesions (with enhanced arterial-phase imaging) is reduced by more than 30% compared with the baseline; Stable disease (SD): Between PR and progressive disease (PD); Progressive disease (PD): The sum of the maximum diameters of target lesions (with enhanced arterial-phase imaging) increases by more than 20% or new lesions appear.
Measured: Evaluate the efficacy of solid tumor treatment according to the criteria established by mRECIST1.1 at the 6th and 12th weeks of the patient's treatment.
DCR
DCR = (Number of CR cases + Number of PR cases + Number of SD cases) / Total number of cases
Measured: through study completion.Continuously follow up the patient's subsequent treatment and survival status，an average of 1 year
Incidence of adverse events
Inc ofidence adverse events = Number of cases with adverse events (AE) / Total number of cases Evaluate the adverse drug reactions and grade them according to the relevant standards in the Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0), which is an internationally recognized standard. These adverse reactions include but are not limited to common ones during drug use, such as fever (body temperature > 38 °C), leukopenia (persistent peripheral white blood cell count < 4.0×10⁹/L), hand - foot syndrome (a combination of skin swelling, peeling, blistering, cracking, bleeding or erythema on the palms and soles, often accompanied by pain), gastrointestinal reactions (including nausea and vomiting), hair loss, etc.
Measured: During anti - tumor treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202531 Dec 2027

First posted5 Aug 2026
Study start1 Jan 2025
Primary completion31 Oct 2026 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Hepatocellular Carcinoma Non-ResectableStudies of the same condition, open and under way.
More trials run by Nanfang Hospital, Southern Medical 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: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07746960
Sponsor's protocol ID: NFEC-2025-009
Status last verified: Jul 2026
First submitted: 20 Jul 2026
Last updated: 5 Aug 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Zang M, Hu X, Yuan G, Li R, Li W, Pang H, Li Q, Chen J. Tyrosine kinase inhibitors, immune checkpoint inhibitors combined with hepatic arterial infusion of oxaliplatin and raltitrexed versus oxaliplatin, 5-fluorouracil and leucovorin for intermediate and advanced hepatocellular carcinoma: A retrospective study. Int Immunopharmacol. 2023 Dec;125(Pt A):111019. doi: 10.1016/j.intimp.2023.111019. Epub 2023 Oct 24.
PubMed 37879230
Zang M, Li Q, Hu X, Pang H, Li R, Li W, Chen Y, Zhu P, Su K, Yuan G, Li Y, Li Y, Chen J. Camrelizumab Combined with Lenvatinib and RALOX-Hepatic Arterial Infusion Chemotherapy for Unresectable Hepatocellular Carcinoma (Cal Era): A Prospective, Single-Arm, Phase II Trial. Liver Cancer. 2025 May 26;14(6):731-742. doi: 10.1159/000546575. eCollection 2025 Dec.
PubMed 40567389
Lyu N, Kong Y, Mu L, Lin Y, Li J, Liu Y, Zhang Z, Zheng L, Deng H, Li S, Xie Q, Guo R, Shi M, Xu L, Cai X, Wu P, Zhao M. Hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin vs. sorafenib for advanced hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):60-69. doi: 10.1016/j.jhep.2018.02.008. Epub 2018 Feb 20.
PubMed 29471013
Qin S, Cheng Y, Liang J, Shen L, Bai Y, Li J, Fan J, Liang L, Zhang Y, Wu G, Rau KM, Yang TS, Jian Z, Liang H, Sun Y. Efficacy and safety of the FOLFOX4 regimen versus doxorubicin in Chinese patients with advanced hepatocellular carcinoma: a subgroup analysis of the EACH study. Oncologist. 2014 Nov;19(11):1169-78. doi: 10.1634/theoncologist.2014-0190. Epub 2014 Sep 15.
PubMed 25223462
Hou JL, Zhao W, Lee C, Hann HW, Peng CY, Tanwandee T, Morozov V, Klinker H, Sollano JD, Streinu-Cercel A, Cheinquer H, Xie Q, Wang YM, Wei L, Jia JD, Gong G, Han KH, Cao W, Cheng M, Tang X, Tan D, Ren H, Duan Z, Tang H, Gao Z, Chen S, Lin S, Sheng J, Chen C, Shang J, Han T, Ji Y, Niu J, Sun J, Chen Y, Cooney EL, Lim SG. Outcomes of Long-term Treatment of Chronic HBV Infection With Entecavir or Other Agents From a Randomized Trial in 24 Countries. Clin Gastroenterol Hepatol. 2020 Feb;18(2):457-467.e21. doi: 10.1016/j.cgh.2019.07.010. Epub 2019 Jul 12.
PubMed 31306800
de Martel C, Georges D, Bray F, Ferlay J, Clifford GM. Global burden of cancer attributable to infections in 2018: a worldwide incidence analysis. Lancet Glob Health. 2020 Feb;8(2):e180-e190. doi: 10.1016/S2214-109X(19)30488-7. Epub 2019 Dec 17.
PubMed 31862245
Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
PubMed 38572751

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatocellular Carcinoma Non-Resectable trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center Exploratory Clinical Study of Chemotherapy With the Ralox Regimen Combined With Anlotinib and Penpulimab for Unresectable Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT07746960
Acronym / sponsor ID: NFEC-2025-009
Conditions: Hepatocellular Carcinoma Non-Resectable
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
Study start: 1 Jan 2025 (actual)
Primary completion: 31 Oct 2026 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 5 Aug 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.

Overall design: This clinical study is a single - center, single - arm, prospective clinical study.

Subjects will receive systemic intravenous chemotherapy combined with immune checkpoint inhibitors and targeted drug therapy:

Penpulimab 200 mg, once every 3 weeks. Anlotinib 12 mg, taken orally once a day, with 2 weeks of administration followed by 1 week of discontinuation.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Group of patients with unresectable hepatocellular carcinoma	Experimental	Drug: Intravenous chemotherapy with the Ralox regimen combined with Anlotinib and Penpulimab

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Adult males or females;
Meeting the relevant criteria in the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)", and diagnosed with HCC through examinations such as ultrasound, enhanced CT and, magnetic resonance imaging, liver puncture biopsy;
Patients with unresectable HCC (patients with recurrence after radical resection are eligible for enrollment);
ECOG PS score ≤ 2;
Liver function of Child-Pugh class A/B, and liver function reserve ICG ≤ 30%;

Key exclusion criteria (8 listed)

Patients with obvious abnormalities in organ and bone marrow functions that are difficult to reverse before randomization, including: hemoglobin < 90 g/L, absolute neutrophil count < 1.0 × 10^9/L, platelet count < 75 × 10^9/L, total bilirubin > 2.0 × the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 5 × ULN, albumin < 28 g/L, international normalized ratio PT - INR > 1.6, glomerular filtration rate (CKD - EPI formula) < 30 mL/min, urine protein ≥ 2+ or 24 - hour urine protein quantification ≥ 1.0 g.
Patients with infection, bleeding tendency, massive ascites and hepatic encephalopathy.
Patients who have been using hepatotoxic drugs for a long - term due to their own diseases and cannot stop taking the drugs.
Patients who have previously received chemotherapy, radiotherapy, immunotherapy or targeted therapy.
Patients with other severe diseases of the heart, brain, kidneys and other organs, autoimmune diseases, or diseases such as HIV/tuberculosis that the researcher deems inappropriate for enrollment.

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
Intravenous chemotherapy with the Ralox regimen combined with Anlotinib and PenpulimabThe intravenous chemotherapy regimen is as follows: Oxaliplatin 100 mg/m², intravenous infusion for 3 hours on Day 1, once every 3 weeks; Raltitrexed 3 mg/m², intravenous infusion for 15 minutes on Day 1. Penpulimab 200 mg, once every 3 weeks. Anlotinib 12 mg, taken orally once a day, with 2 weeks of administration followed by 1 week of discontinuation	Drug	Group of patients with unresectable hepatocellular carcinoma

Primary outcome

ORR
Time frame: through study completion.Continuously follow up the patient's subsequent treatment and survival status，an average of 1 year
ORR = (Number of CR cases + Number of PR cases) / Total number of cases

3 secondary outcomes

Conduct imaging evaluation
Time frame: Evaluate the efficacy of solid tumor treatment according to the criteria established by mRECIST1.1 at the 6th and 12th weeks of the patient's treatment.
DCR
Time frame: through study completion.Continuously follow up the patient's subsequent treatment and survival status，an average of 1 year
Incidence of adverse events
Time frame: During anti - tumor treatment

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 5 Aug 2026.
Background: PubMed 37879230Zang M, Hu X, Yuan G, Li R, Li W, Pang H, Li Q, Chen J. Tyrosine kinase inhibitors, immune checkpoint inhibitors combined with hepatic arterial infusion of oxaliplatin and raltitrexed versus oxaliplatin, 5-fluorouracil and leucovorin for intermediate and advanced hepatocellular carcinoma: A retrospective study. Int Immunopharmacol. 2023 Dec;125(Pt A):111019. doi: 10.1016/j.intimp.2023.111019. Epub 2023 Oct 24.
Background: PubMed 40567389Zang M, Li Q, Hu X, Pang H, Li R, Li W, Chen Y, Zhu P, Su K, Yuan G, Li Y, Li Y, Chen J. Camrelizumab Combined with Lenvatinib and RALOX-Hepatic Arterial Infusion Chemotherapy for Unresectable Hepatocellular Carcinoma (Cal Era): A Prospective, Single-Arm, Phase II Trial. Liver Cancer. 2025 May 26;14(6):731-742. doi: 10.1159/000546575. eCollection 2025 Dec.
Background: PubMed 29471013Lyu N, Kong Y, Mu L, Lin Y, Li J, Liu Y, Zhang Z, Zheng L, Deng H, Li S, Xie Q, Guo R, Shi M, Xu L, Cai X, Wu P, Zhao M. Hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin vs. sorafenib for advanced hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):60-69. doi: 10.1016/j.jhep.2018.02.008. Epub 2018 Feb 20.
Background: PubMed 25223462Qin S, Cheng Y, Liang J, Shen L, Bai Y, Li J, Fan J, Liang L, Zhang Y, Wu G, Rau KM, Yang TS, Jian Z, Liang H, Sun Y. Efficacy and safety of the FOLFOX4 regimen versus doxorubicin in Chinese patients with advanced hepatocellular carcinoma: a subgroup analysis of the EACH study. Oncologist. 2014 Nov;19(11):1169-78. doi: 10.1634/theoncologist.2014-0190. Epub 2014 Sep 15.
Background: PubMed 31306800Hou JL, Zhao W, Lee C, Hann HW, Peng CY, Tanwandee T, Morozov V, Klinker H, Sollano JD, Streinu-Cercel A, Cheinquer H, Xie Q, Wang YM, Wei L, Jia JD, Gong G, Han KH, Cao W, Cheng M, Tang X, Tan D, Ren H, Duan Z, Tang H, Gao Z, Chen S, Lin S, Sheng J, Chen C, Shang J, Han T, Ji Y, Niu J, Sun J, Chen Y, Cooney EL, Lim SG. Outcomes of Long-term Treatment of Chronic HBV Infection With Entecavir or Other Agents From a Randomized Trial in 24 Countries. Clin Gastroenterol Hepatol. 2020 Feb;18(2):457-467.e21. doi: 10.1016/j.cgh.2019.07.010. Epub 2019 Jul 12.
Background: PubMed 31862245de Martel C, Georges D, Bray F, Ferlay J, Clifford GM. Global burden of cancer attributable to infections in 2018: a worldwide incidence analysis. Lancet Glob Health. 2020 Feb;8(2):e180-e190. doi: 10.1016/S2214-109X(19)30488-7. Epub 2019 Dec 17.
Background: PubMed 38572751Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: through study completion.Continuously follow up the patient's subsequent treatment and survival status，an average of 1 year). 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 NCT07746960, which also lists 7 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 5 Aug 2026.