Locally Advanced Pancreatic CancerPhase 1/2NCT07802184
GnP Combined With SHR-1701 and Apatinib as First-Line Treatment for Locally Advanced or Metastatic PDAC
A Phase 1/2 study testing SHR-1701, Apatinib and gemcitabine in people with Locally Advanced Pancreatic Cancer and Metastatic Pancreatic Cancer, run by West China Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety and efficacy of GnP combined with SHR-1701 and Apatinib as first-line treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Pancreatic Cancer, Metastatic Pancreatic Cancer
- What is being tested?
- SHR-1701, Apatinib and gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2026to 1 May 2029
- Phase
- Phase 1/2
- 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
- 1) Age 18-75 years, regardless of sex; 2) patients with histologically confirmed pancreatic ductal adenocarcinoma (PDAC); 3) previously untreated patients with unresectable locally advanced or metastatic PDAC, with at least one measurable lesion according to RECIST v1.1, and target lesions must not have received prior radiotherapy or local treatment; 4) ECOG performance status of 0-1; 5) life expectancy ≥3 months; 6) willingness to comply with study procedures and able to receive treatment and undergo follow-up; 7) adequate major organ function, with laboratory test results meeting the following criteria within 7 days before enrollment: white blood cell (WBC) count ≥2.5×10⁹/L, absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet (PLT) count ≥75×10⁹/L, hemoglobin (HGB) ≥90 g/L (without blood transfusion or erythropoietin [EPO] dependence within 7 days), total bilirubin (TBIL) ≤1.5× the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN, albumin ≥30 g/L, international normalized ratio (INR) ≤1.5×ULN, serum creatinine (Cr) ≤1.5×ULN, and urinary protein ≤1+; 8) patients who are hepatitis B surface antigen (HBsAg)-positive with a peripheral blood hepatitis B virus DNA (HBV-DNA) level ≤1×10³/L; patients who are HBsAg-positive with a peripheral blood HBV-DNA level ≥1×10³/L may also be eligible if, in the investigator's judgment, chronic hepatitis B is clinically stable and does not increase the patient's risk; 9) voluntary participation in the study and provision of written informed consent.
Who cannot join
- 1) Known hypersensitivity to any study drug; 2) known or suspected central nervous system metastases, defined as signs or symptoms suggestive of CNS metastasis, unless CNS metastasis has been excluded by CT or MRI; 3) history of other malignancies within 5 years, except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix; 4) requiring any concomitant anticancer treatment other than the study treatment during the study, including chemotherapy, targeted therapy, hormonal therapy, immunotherapy, radiotherapy, or traditional Chinese medicine with antitumor activity; 5) prior or current treatment with chemotherapy, FAK inhibitors, or antibodies targeting PD-1, PD-L1, PD-L2, CD137, or cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), including ipilimumab or any other antibody or drug targeting T-cell costimulatory or checkpoint pathways; 6) diagnosis of immunodeficiency or chronic systemic corticosteroid therapy (prednisone >10 mg/day or equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment; 7) receipt of a live vaccine within 30 days before the first dose of study treatment, including but not limited to measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccines; inactivated seasonal influenza vaccines are permitted, whereas live attenuated vaccines such as intranasal influenza vaccines (e.g., FluMist) are not permitted; 8) uncontrolled hypertension, defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg despite treatment; 9) significant cardiac disease, including congestive heart failure (NYHA class III-IV), previous myocardial infarction, or uncontrolled angina within 6 months; 10) clinically significant arrhythmias requiring treatment, including atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, or ventricular fibrillation, or ECG abnormalities confirmed on repeat examination that, in the investigator's judgment, require clinical intervention or treatment; 11) history of hemorrhagic or thromboembolic events within the past 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, or spontaneous major tumor-related bleeding; 12) surgery required within 28 days before or anticipated within 28 days after the last dose of study treatment; 13) uncontrolled third-space fluid accumulation, such as large pleural effusion or ascites; 14) definite gastrointestinal bleeding tendency within 4 weeks before the first dose, including: ① active localized ulcerative lesions with positive fecal occult blood; ② melena or hematemesis within 28 days; or ③ positive fecal occult blood in patients with unresected tumor invasion of the gastrointestinal tract who, in the opinion of the principal investigator at the study center, may be at risk of major gastrointestinal bleeding; 15) previous gastrointestinal perforation or suspected risk of gastrointestinal perforation, or intestinal obstruction; 16) concomitant medications that, in the investigator's judgment, are required during the trial and may affect the metabolism of the investigational drug, such as strong CYP3A4 inhibitors or inducers, or drugs with a narrow therapeutic index that are primarily metabolized by CYP3A4, CYP2C8, CYP2C9, CYP2C19, or CYP2D6; 17) severe psychiatric disorders; 18) women who are pregnant, breastfeeding, or potentially pregnant; 19) women or men of childbearing potential unwilling to use effective contraception during the study and for 3 months after the last dose of study treatment; 20) participation in another clinical trial of a drug or medical device within 4 weeks before enrollment; 21) any other condition that, in the investigator's judgment, makes the patient unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Min Ren contact
China1 site
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Dan Cao, +8618980605963, caodan@scu.edu.cn
About this study
Official title: GnP Combined With SHR-1701 and Apatinib as First-Line Treatment for Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma: A Single-Center, Open-Label, Phase Ib/II Trial
The goal of this clinical trial is to evaluate the safety and efficacy of GnP combined with SHR-1701 and Apatinib as first-line treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma.
Read the detailed description
This study is a prospective, single-arm, single-center, phase Ib/II clinical trial evaluating the safety and efficacy of GnP combined with SHR-1701 and Apatinib as first-line treatment in patients with locally advanced or metastatic pancreatic cancer.
- Being tested
- SHR-1701, Apatinib, gemcitabine, Nab-paclitaxel
- Keywords
- Locally advanced pancreatic cancer, Metastatic pancreatic cancer, SHR-1701, Apatinib, GnP
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1701Drug
SHR-1701 is administered by intravenous infusion at a dose of 30 mg/kg once every 3 weeks (Q3W). The dose may be adjusted to the recommended phase II dose (RP2D) determined during the phase Ib safety run-in phase.
ApatinibDrug
Apatinib is administered orally at a dose of 250 mg once daily (QD). The dose may be adjusted to the recommended phase II dose (RP2D) determined during the phase Ib safety run-in phase.
gemcitabineDrug
Gemcitabine is administered by intravenous infusion at a dose of 1000 mg/m² on days 1 and 8 of each 3-week cycle.
Nab-paclitaxelDrug
Nab-paclitaxel is administered by intravenous infusion at a dose of 125 mg/m² on days 1 and 8 of each 3-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| SHR-1701 combined with Apatinib and GnP | Experimental | Not described Receives: Drug: SHR-1701; Drug: Apatinib; Drug: gemcitabine; Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase II Dose (RP2D)
RP2D will be determined on the basis of evaluation on safety and efficacy data in Phase Ib.
Measured: through phase I study completion, an average of 5 months
Objective Response Rate (ORR)
Proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST v1.1 criteria.
Measured: through study completion, an average of 2 years
Secondary outcomes (8)
Overall Survival (OS)
Time from the first administration of study treatment to death from any cause. Participants who are alive or lost to follow-up at the time of analysis will be censored at the date of their last known survival assessment.
Measured: through study completion, an average of 2 years
Progression-Free Survival (PFS)
Time from the first administration of study treatment to the first documented disease progression according to RECIST v1.1 or death from any cause, whichever occurs first. Participants who are alive and have not experienced disease progression will be censored at the date of the last tumor assessment.
Measured: through study completion, an average of 2 years
Disease Control Rate (DCR)
Proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) as the best overall response according to RECIST v1.1 criteria.
Measured: through study completion, an average of 2 years
Duration of Response (DOR)
Time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.
Measured: through study completion, an average of 2 years
Time to Progression (TTP)
Time from the first administration of study treatment to the first documented disease progression according to RECIST v1.1 in the ITT population. Participants who have not experienced disease progression at the time of analysis will be censored at the date of the last tumor assessment.
Measured: through study completion, an average of 2 years
R0 Resection Rate
Proportion of participants in the ITT population who undergo surgical resection and achieve R0 resection, defined as complete macroscopic tumor removal with no microscopic residual tumor at the resection margin.
Measured: through study completion, an average of 2 years
Incidence of Treatment-Related Adverse Events (TRAEs)
Incidence and severity of adverse events considered by the investigator to be related to study treatment, graded according to NCI-CTCAE version 5.0.
Measured: through study completion, an average of 2 years
Incidence of Serious Adverse Events (SAEs)
Incidence of serious adverse events, including events resulting in death, life-threatening events, hospitalization or prolongation of hospitalization, persistent or significant disability, congenital anomaly, or other medically important events.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by West China 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Cao, West China Hospital
- Investigators
- Dan Cao, Principal investigator, Division of Abdominal Tumor, Department of Medical Oncology, Cancer Center and State Key Laboratory of Biological Therapy, West China Hospital, Sichuan University, Chengdu, Sichuan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802184
- Sponsor's protocol ID
- SHR1701-IIT-PDAC001
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy protection requirements, regulatory restrictions in China, and limitations in the original informed consent process that did not include provisions for external data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GnP Combined With SHR-1701 and Apatinib as First-Line Treatment for Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma: A Single-Center, Open-Label, Phase Ib/II Trial
- ClinicalTrials.gov ID
- NCT07802184
- Acronym / sponsor ID
- SHR1701-IIT-PDAC001
- Keywords
- Locally advanced pancreatic cancer, Metastatic pancreatic cancer, SHR-1701, Apatinib, GnP
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 3 Sep 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.
The goal of this clinical trial is to evaluate the safety and efficacy of GnP combined with SHR-1701 and Apatinib as first-line treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma.
Detailed description
This study is a prospective, single-arm, single-center, phase Ib/II clinical trial evaluating the safety and efficacy of GnP combined with SHR-1701 and Apatinib as first-line treatment in patients with locally advanced or metastatic pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-1701 combined with Apatinib and GnP | Experimental | Drug: SHR-1701, Drug: Apatinib, Drug: gemcitabine, Drug: Nab-paclitaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Age 18-75 years, regardless of sex; 2) patients with histologically confirmed pancreatic ductal adenocarcinoma (PDAC); 3) previously untreated patients with unresectable locally advanced or metastatic PDAC, with at least one measurable lesion according to RECIST v1.1, and target lesions must not have received prior radiotherapy or local treatment; 4) ECOG performance status of 0-1; 5) life expectancy ≥3 months; 6) willingness to comply with study procedures and able to receive treatment and undergo follow-up; 7) adequate major organ function, with laboratory test results meeting the following criteria within 7 days before enrollment: white blood cell (WBC) count ≥2.5×10⁹/L, absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet (PLT) count ≥75×10⁹/L, hemoglobin (HGB) ≥90 g/L (without blood transfusion or erythropoietin [EPO] dependence within 7 days), total bilirubin (TBIL) ≤1.5× the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN, albumin ≥30 g/L, international normalized ratio (INR) ≤1.5×ULN, serum creatinine (Cr) ≤1.5×ULN, and urinary protein ≤1+; 8) patients who are hepatitis B surface antigen (HBsAg)-positive with a peripheral blood hepatitis B virus DNA (HBV-DNA) level ≤1×10³/L; patients who are HBsAg-positive with a peripheral blood HBV-DNA level ≥1×10³/L may also be eligible if, in the investigator's judgment, chronic hepatitis B is clinically stable and does not increase the patient's risk; 9) voluntary participation in the study and provision of written informed consent.
Key exclusion criteria (1 listed)
- 1) Known hypersensitivity to any study drug; 2) known or suspected central nervous system metastases, defined as signs or symptoms suggestive of CNS metastasis, unless CNS metastasis has been excluded by CT or MRI; 3) history of other malignancies within 5 years, except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix; 4) requiring any concomitant anticancer treatment other than the study treatment during the study, including chemotherapy, targeted therapy, hormonal therapy, immunotherapy, radiotherapy, or traditional Chinese medicine with antitumor activity; 5) prior or current treatment with chemotherapy, FAK inhibitors, or antibodies targeting PD-1, PD-L1, PD-L2, CD137, or cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), including ipilimumab or any other antibody or drug targeting T-cell costimulatory or checkpoint pathways; 6) diagnosis of immunodeficiency or chronic systemic corticosteroid therapy (prednisone >10 mg/day or equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment; 7) receipt of a live vaccine within 30 days before the first dose of study treatment, including but not limited to measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccines; inactivated seasonal influenza vaccines are permitted, whereas live attenuated vaccines such as intranasal influenza vaccines (e.g., FluMist) are not permitted; 8) uncontrolled hypertension, defined as systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg despite treatment; 9) significant cardiac disease, including congestive heart failure (NYHA class III-IV), previous myocardial infarction, or uncontrolled angina within 6 months; 10) clinically significant arrhythmias requiring treatment, including atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, or ventricular fibrillation, or ECG abnormalities confirmed on repeat examination that, in the investigator's judgment, require clinical intervention or treatment; 11) history of hemorrhagic or thromboembolic events within the past 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, or spontaneous major tumor-related bleeding; 12) surgery required within 28 days before or anticipated within 28 days after the last dose of study treatment; 13) uncontrolled third-space fluid accumulation, such as large pleural effusion or ascites; 14) definite gastrointestinal bleeding tendency within 4 weeks before the first dose, including: ① active localized ulcerative lesions with positive fecal occult blood; ② melena or hematemesis within 28 days; or ③ positive fecal occult blood in patients with unresected tumor invasion of the gastrointestinal tract who, in the opinion of the principal investigator at the study center, may be at risk of major gastrointestinal bleeding; 15) previous gastrointestinal perforation or suspected risk of gastrointestinal perforation, or intestinal obstruction; 16) concomitant medications that, in the investigator's judgment, are required during the trial and may affect the metabolism of the investigational drug, such as strong CYP3A4 inhibitors or inducers, or drugs with a narrow therapeutic index that are primarily metabolized by CYP3A4, CYP2C8, CYP2C9, CYP2C19, or CYP2D6; 17) severe psychiatric disorders; 18) women who are pregnant, breastfeeding, or potentially pregnant; 19) women or men of childbearing potential unwilling to use effective contraception during the study and for 3 months after the last dose of study treatment; 20) participation in another clinical trial of a drug or medical device within 4 weeks before enrollment; 21) any other condition that, in the investigator's judgment, makes the patient unsuitable 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 |
|---|---|---|
| SHR-1701SHR-1701 is administered by intravenous infusion at a dose of 30 mg/kg once every 3 weeks (Q3W). The dose may be adjusted to the recommended phase II dose (RP2D) determined during the phase Ib safety run-in phase. | Drug | SHR-1701 combined with Apatinib and GnP |
| ApatinibApatinib is administered orally at a dose of 250 mg once daily (QD). The dose may be adjusted to the recommended phase II dose (RP2D) determined during the phase Ib safety run-in phase. | Drug | SHR-1701 combined with Apatinib and GnP |
| gemcitabineGemcitabine is administered by intravenous infusion at a dose of 1000 mg/m² on days 1 and 8 of each 3-week cycle. | Drug | SHR-1701 combined with Apatinib and GnP |
| Nab-paclitaxelNab-paclitaxel is administered by intravenous infusion at a dose of 125 mg/m² on days 1 and 8 of each 3-week cycle. | Drug | SHR-1701 combined with Apatinib and GnP |
Primary outcome
Recommended Phase II Dose (RP2D)
Time frame: through phase I study completion, an average of 5 months
RP2D will be determined on the basis of evaluation on safety and efficacy data in Phase Ib.
Objective Response Rate (ORR)
Time frame: through study completion, an average of 2 years
Proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST v1.1 criteria.
8 secondary outcomes
Overall Survival (OS)
Time frame: through study completion, an average of 2 years
Progression-Free Survival (PFS)
Time frame: through study completion, an average of 2 years
Disease Control Rate (DCR)
Time frame: through study completion, an average of 2 years
Duration of Response (DOR)
Time frame: through study completion, an average of 2 years
Time to Progression (TTP)
Time frame: through study completion, an average of 2 years
R0 Resection Rate
Time frame: through study completion, an average of 2 years
Incidence of Treatment-Related Adverse Events (TRAEs)
Time frame: through study completion, an average of 2 years
Incidence of Serious Adverse Events (SAEs)
Time frame: through study completion, an average of 2 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 3 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy protection requirements, regulatory restrictions in China, and limitations in the original informed consent process that did not include provisions for external data sharing.
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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.
Min Ren contact
Dan Cao principal investigator
Division of Abdominal Tumor, Department of Medical Oncology, Cancer Center and State Key Laboratory of Biological Therapy, West China Hospital, Sichuan University, Chengdu, Sichuan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SHR-1701, Apatinib and gemcitabine in people with Locally Advanced Pancreatic Cancer and Metastatic Pancreatic Cancer, run by West China Hospital 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 1 inclusion and 1 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 3 Sep 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 combined 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.
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 Dan Cao (+8618980605963, caodan@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase II Dose (RP2D) (time frame: through phase I study completion, an average of 5 months). The study lists 2 primary outcomes in all. 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 3 Sep 2026.