Esophageal CancerPhase 2OMEC-5NCT07000253
Timing of Comprehensive Local Treatment After First-Line Systemic Therapy in Oligometastatic Esophageal or Gastric Adenocarcinoma
A Phase 2 study testing Chemotherapy, Targeted Systemic Therapy and Immunotherapy in people with Esophageal Cancer and Gastric (Stomach) Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 5 sites in 3 countries.
Trial summary
Purpose of the Study: This clinical study investigates whether a shorter or longer duration of systemic therapy before local treatment (surgery or radiation) results in better disease control in patients with esophageal or gastric cancer with a limited number of metastases, also known as oligometastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Gastric (Stomach) Cancer, Gastric Adenocarcinoma
- What is being tested?
- Chemotherapy, Targeted Systemic Therapy and Immunotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 29 Apr 2026to Jan 2034
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Ability to provide written informed consent
- Histologically confirmed esophageal, gastric or gastroesophageal junction tumor with oligometastatic (M1) disease defined according to the OMEC consensus statement:
- One organ with ≤3 metastases or 1 involved extra-regional lymph node station (based on the TNM 8 classification)
- ≤3 unilobar liver metastases or ≤2 bilobar liver metastases
- ≤ 3 unilateral lung metastases
Show all 19Show fewer
- Unilateral adrenal gland involvement
- Metastasis confined to 1 bone structure or 1 soft tissue compartment
- Synchronous oligometastatic disease with a resectable primary tumor or metachronous oligometastatic disease (in the event of a locoregional recurrence this should be resectable)
- Metastases should be deemed amenable by the international multidisciplinary expert team for radical local treatment
- WHO performance status 0-2
- Indication for checkpoint inhibition and/or targeted therapy
- PD-L1 with a CPS of 1 or higher as per local clinical practice for immunotherapy use
- HER2 overexpression as per local clinical practice for trastuzumab use
- Claudin 18.2 overexpression as per local clinical practice for zolbetuximab use.
- Any other biomarker that allows targeted therapy in first line approved by EMA
- No prior systemic therapy for metastatic disease
- CT-scan ≤8 weeks prior to inclusion
- Ability to undergo local treatment and start systemic treatment beyond 18 weeks of total systemic treatment.
Who cannot join
- Squamous cell carcinoma
- Brain metastases
- Peritoneal or pleural carcinomatosis
- Patients with MSI dMMR
- Uncontrolled immunodeficiency (e.g. AIDS)
- Peripheral neuropathy >CTCAE grade 1, precluding start of full dose oxaliplatin treatment
Show all 18Show fewer
- Both organ metastasis and extra-regional lymph node metastasis
- Conditions precluding local treatment or systemic therapy for oligometastatic disease:
- Serious medical comorbidities precluding local treatment (e.g., interstitial lung disease in patients with pulmonary metastasis)
- Clinical or radiological evidence of spinal cord compression or epidural tumor within 2 mm of the spinal cord
- Simultaneous other malignancy or previous other malignancy with a disease-free period of <5 years, except adequately treated non-melanoma skin cancer or in-situ cancers
- Uncontrolled (bacterial) infections
- Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments
- Uncontrolled angina pectoris, cardiac failure or clinically significant arrhythmias
- Continuous use of immunosuppressive agents equivalent to >10 mg daily prednisone
- Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine
- Pregnancy or breast feeding
- Patients (M/F) with reproductive potential not implementing adequate contraceptive measures
Trial locations and contacts
5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Richard van Hillgersberg, MD, PhD contact
5 sites in 3 countries
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam University Medical Center
Amsterdam
Hanneke van Laarhoven, MD, PhD, PhD, +31204444321, h.vanlaarhoven@amsterdamumc.nl
Peter van Rossum, MD, PhD, p.s.n.vanrossum@amsterdamumc.nl
- Not yet recruiting
UMC Utrecht
Utrecht
Richard van Hillegersberg, +313088 755 5555, r.vanhillgersberg@umcutrecht.nl
Norway2 sites, 2 recruiting
- Recruiting
University of Oslo
Oslo
- Recruiting
University of North Norway
Tromsø
Spain1 site, 1 recruiting
- Recruiting
Instituto de Investigación Sanitaria - INCLIVA
Valencia
About this study
Official title: Timing of Minimally Invasive Local Treatment After First-Line Systemic Therapy in Oligometastatic Esophageal or Gastric Adenocarcinoma: A Randomized Prospective Clinical Study (OMEC-5)
Purpose of the Study:
This clinical study investigates whether a shorter or longer duration of systemic therapy before local treatment (surgery or radiation) results in better disease control in patients with esophageal or gastric cancer with a limited number of metastases, also known as oligometastases.
Read more
Background:
In about 25% of patients with advanced esophageal or gastric cancer, the disease spreads to only a few sites (oligometastatic disease). Prior studies suggest that local treatment after systemic therapy may extend survival in this subgroup. However, it is unclear how long systemic therapy should last before initiating local treatment. The OMEC-5 study aims to clarify this.
Study Design:
Initiated by Amsterdam UMC and UMCU and conducted in multiple hospitals across Europe.
Total of 414 patients to be enrolled.
Duration: ~53 months (35 months enrollment + 18 months follow-up).
Approved by the medical ethics committee at Amsterdam UMC.
Procedure:
Eligibility screening: Includes physical exam, blood tests (incl. circulating tumor cells), medical history review, and confirmation of oligometastases by an expert panel.
Initial treatment: All participants receive 4 months of standard systemic therapy (chemotherapy + immunotherapy and/or targeted therapy depending on tumor markers like HER2 or Claudin 18.2).
Response assessment (Review 1): Imaging and/or laparoscopic examination.
If oligometastases persist and tumors have not progressed, participants are randomized into two groups:
Group A (longer systemic therapy): 4 more months of systemic therapy, then local treatment if disease is stable, followed by 4 months of immunotherapy ± targeted therapy.
Group B (shorter systemic therapy): Immediate local treatment followed by 4 months of systemic therapy, then reassessment and potentially 4 months of immunotherapy ± targeted therapy.
Follow-up: Regular scans and quality-of-life questionnaires (5 times), and periodic blood sampling (4 times).
Treatments Involved:
Chemotherapy: CapOx or FOLFOX
Immunotherapy: nivolumab or pembrolizumab
Targeted therapy: trastuzumab (HER2-positive) or zolbetuximab (Claudin 18.2-positive)
Potential Benefits and Risks:
Patients may benefit from better disease control and a personalized treatment strategy.
Known side effects relate to the standard treatments used (chemo, immuno, targeted therapies), and no extra medical risk is expected beyond routine care.
Possible inconveniences include blood draws, scans, minor surgery (laparoscopy), and time investment.
Data and Sample Handling:
Personal data and tumor/blood samples for exploratory research (if patients consent) are coded and securely stored.
Data may be used for future cancer research if the patient consents.
Participants can withdraw at any time.
Confidentiality and Privacy:
Patient data are kept confidential, and participants have rights to access or delete their data. Privacy measures comply with GDPR and Dutch law.
Compensation and Insurance:
Participation is voluntary, with no financial compensation. Standard treatment costs are covered by healthcare insurance. No extra insurance is required, as the treatment aligns with standard care practices.
- Conditions
- Esophageal Cancer, Gastric (Stomach) Cancer, Gastric Adenocarcinoma, Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma, Esophageal Carcinoma, Gastric (Cardia, Body) Cancer
- Being tested
- Chemotherapy, Targeted Systemic Therapy, Immunotherapy, Surgery, Radiotherapy
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Chemotherapy preferably CapOx (capecitabine + oxaliplatin) or FOLFOX (5-fluoruracil, leucovorin and oxaliplatin) will be combined with immunotherapy (preferably nivolumab or pembrolizumab) and/or targeted therapy (for example trastuzumab in the case of HER2 overexpression or zolbetuximab in the case of Claudin 18.2 overexpression). These regiments are the standard-of-care (SOC) combination therapies used in this study. Acceptable chemotherapy regimens predominantly for Asian centers include SOX (S-1 and Oxaliplatin).
Targeted Systemic TherapyDrug
Biomarker selected patients will receive trastuzumab, zolbetuximab or any other targeted agent according to standard of care.
ImmunotherapyDrug
Biomarker selected patients will recieve checkpoint inhibitors according to standard care
SurgeryProcedure or surgery
If the primary tumor is present, this tumor will be surgically removed. Metastases may also be removed by surgery.
RadiotherapyRadiation
Metastases may be irradiated
| Study group | Role | What they receive |
|---|---|---|
| long duration of systemic therapy | Experimental | Patients with no disease progression at 4 months (18 weeks) after systemic therapy with oxaliplatin, fluorpyrimidine, checkpoint inhibitor and/or taregted therapy and fit for local treatment will receive 4 additional months of systemic therapy and subsequent evaluation for local treatment to all disease sites. Receives: Drug: Chemotherapy; Drug: Targeted Systemic Therapy; Drug: Immunotherapy; Procedure: Surgery; Radiation: Radiotherapy |
| Short duration of systemic therapy | Active comparator | Patients with no disease progression at 4 months (18 weeks) after systemic therapy oxaliplatin, fluorpyrimidine, checkpoint inhibitor and/or targeted therapy and fit for local treatment will recieve direct local treatment to all disease sites. Receives: Drug: Chemotherapy; Drug: Targeted Systemic Therapy; Drug: Immunotherapy; Procedure: Surgery; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
the time interval from the date of randomization to the date of first occurrence of the following events (or last follow-up) up to 53 months after study initiation:
- Disease progression (consisting of either progression in the number of metastases, recurrence at surgically treated metastasis, progression of ablated or irradiated metastasis, or recurrence of the primary tumor or regional lymph node metastasis)
- Death due to any cause.
Measured: the time interval from the date of randomization to the date of first occurrence of the following events (or last follow-up) up to 53 months after study initiation: Disease progression, death
Secondary outcomes (2)
Overall survival (OS)
Measured: Interval between randomization and death or last follow-up up to 53 months after study initiation
2. Quality of Life (QoL)
Measured by the Summary Score of the EORTC QLQ-C30
Measured: At 12 months after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2025
- Study start29 Apr 2026
- Primary completionNov 2031 (estimated)
- Study completionJan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht
- Responsible party
- Principal investigator, Hanneke W. M. van Laarhoven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Peter van Rossum, MD, PhD, Principal investigator, Amsterdam UMCRichard van Hillgersberg, MD, PhD, Principal investigator, UMC UtrechtHanneke van Laarhoven, MD, PhD, PhD, Principal investigator, Amsterdam UMCTiuri Kroese, MD, PhD, Study director, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000253
- Sponsor's protocol ID
- OMEC-5
- Acronym
- OMEC-5
- Status last verified
- Sep 2026
- First submitted
- 8 May 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Minimally Invasive Local Treatment After First-Line Systemic Therapy in Oligometastatic Esophageal or Gastric Adenocarcinoma: A Randomized Prospective Clinical Study (OMEC-5)
- ClinicalTrials.gov ID
- NCT07000253
- Acronym / sponsor ID
- OMEC-5 / OMEC-5
- Conditions
- Esophageal Cancer, Gastric (Stomach) Cancer, Gastric Adenocarcinoma, Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma, Esophageal Carcinoma, Gastric (Cardia, Body) Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- UMC Utrecht
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- Nov 2031 (estimated)
- Study completion
- Jan 2034 (estimated)
- First posted
- 2 Jun 2025 (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.
Purpose of the Study:
This clinical study investigates whether a shorter or longer duration of systemic therapy before local treatment (surgery or radiation) results in better disease control in patients with esophageal or gastric cancer with a limited number of metastases, also known as oligometastases.
Background:
In about 25% of patients with advanced esophageal or gastric cancer, the disease spreads to only a few sites (oligometastatic disease). Prior studies suggest that local treatment after systemic therapy may extend survival in this subgroup. However, it is unclear how long systemic therapy should last before initiating local treatment. The OMEC-5 study aims to clarify this.
Study Design:
Initiated by Amsterdam UMC and UMCU and conducted in multiple hospitals across Europe.
Total of 414 patients to be enrolled.
Duration: ~53 months (35 months enrollment + 18 months follow-up).
Approved by the medical ethics committee at Amsterdam UMC.
Procedure:
Eligibility screening: Includes physical exam, blood tests (incl. circulating tumor cells), medical history review, and confirmation of oligometastases by an expert panel.
Initial treatment: All participants receive 4 months of standard systemic therapy (chemotherapy + immunotherapy and/or targeted therapy depending on tumor markers like HER2 or Claudin 18.2).
Response assessment (Review 1): Imaging and/or laparoscopic examination.
If oligometastases persist and tumors have not progressed, participants are randomized into two groups:
Group A (longer systemic therapy): 4 more months of systemic therapy, then local treatment if disease is stable, followed by 4 months of immunotherapy ± targeted therapy.
Group B (shorter systemic therapy): Immediate local treatment followed by 4 months of systemic therapy, then reassessment and potentially 4 months of immunotherapy ± targeted therapy.
Follow-up: Regular scans and quality-of-life questionnaires (5 times), and periodic blood sampling (4 times).
Treatments Involved:
Chemotherapy: CapOx or FOLFOX
Immunotherapy: nivolumab or pembrolizumab
Targeted therapy: trastuzumab (HER2-positive) or zolbetuximab (Claudin 18.2-positive)
Potential Benefits and Risks:
Patients may benefit from better disease control and a personalized treatment strategy.
Known side effects relate to the standard treatments used (chemo, immuno, targeted therapies), and no extra medical risk is expected beyond routine care.
Possible inconveniences include blood draws, scans, minor surgery (laparoscopy), and time investment.
Data and Sample Handling:
Personal data and tumor/blood samples for exploratory research (if patients consent) are coded and securely stored.
Data may be used for future cancer research if the patient consents.
Participants can withdraw at any time.
Confidentiality and Privacy:
Patient data are kept confidential, and participants have rights to access or delete their data. Privacy measures comply with GDPR and Dutch law.
Compensation and Insurance:
Participation is voluntary, with no financial compensation. Standard treatment costs are covered by healthcare insurance. No extra insurance is required, as the treatment aligns with standard care practices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| long duration of systemic therapy | Experimental | Drug: Chemotherapy, Drug: Targeted Systemic Therapy, Drug: Immunotherapy, Procedure: Surgery, Radiation: RadiotherapyPatients with no disease progression at 4 months (18 weeks) after systemic therapy with oxaliplatin, fluorpyrimidine, checkpoint inhibitor and/or taregted therapy and fit for local treatment will receive 4 additional months of systemic therapy and subsequent evaluation for local treatment to all disease sites. |
| Short duration of systemic therapy | Active comparator | Drug: Chemotherapy, Drug: Targeted Systemic Therapy, Drug: Immunotherapy, Procedure: Surgery, Radiation: RadiotherapyPatients with no disease progression at 4 months (18 weeks) after systemic therapy oxaliplatin, fluorpyrimidine, checkpoint inhibitor and/or targeted therapy and fit for local treatment will recieve direct local treatment to all disease sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥18 years
- Ability to provide written informed consent
- Histologically confirmed esophageal, gastric or gastroesophageal junction tumor with oligometastatic (M1) disease defined according to the OMEC consensus statement:
- Synchronous oligometastatic disease with a resectable primary tumor or metachronous oligometastatic disease (in the event of a locoregional recurrence this should be resectable)
- Metastases should be deemed amenable by the international multidisciplinary expert team for radical local treatment
Key exclusion criteria (18 listed)
- Squamous cell carcinoma
- Brain metastases
- Peritoneal or pleural carcinomatosis
- Patients with MSI dMMR
- Uncontrolled immunodeficiency (e.g. AIDS)
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 |
|---|---|---|
| ChemotherapyChemotherapy preferably CapOx (capecitabine + oxaliplatin) or FOLFOX (5-fluoruracil, leucovorin and oxaliplatin) will be combined with immunotherapy (preferably nivolumab or pembrolizumab) and/or targeted therapy (for example trastuzumab in the case of HER2 overexpression or zolbetuximab in the case of Claudin 18.2 overexpression). These regiments are the standard-of-care (SOC) combination therapies used in this study. Acceptable chemotherapy regimens predominantly for Asian centers include SOX (S-1 and Oxaliplatin). | Drug | Short duration of systemic therapy, long duration of systemic therapy |
| Targeted Systemic TherapyBiomarker selected patients will receive trastuzumab, zolbetuximab or any other targeted agent according to standard of care. | Drug | Short duration of systemic therapy, long duration of systemic therapy |
| ImmunotherapyBiomarker selected patients will recieve checkpoint inhibitors according to standard care | Drug | Short duration of systemic therapy, long duration of systemic therapy |
| SurgeryIf the primary tumor is present, this tumor will be surgically removed. Metastases may also be removed by surgery. | Procedure or surgery | Short duration of systemic therapy, long duration of systemic therapy |
| RadiotherapyMetastases may be irradiated | Radiation | Short duration of systemic therapy, long duration of systemic therapy |
Primary outcome
progression free survival
Time frame: the time interval from the date of randomization to the date of first occurrence of the following events (or last follow-up) up to 53 months after study initiation: Disease progression, death
the time interval from the date of randomization to the date of first occurrence of the following events (or last follow-up) up to 53 months after study initiation: * Disease progression (consisting of either progression in the number of metastases, recurrence at surgically treated metastasis, progression of ablated or irradiated metastasis, or recurrence of the primary tumor or regional lymph node metastasis) * Death due to any cause.
2 secondary outcomes
Overall survival (OS)
Time frame: Interval between randomization and death or last follow-up up to 53 months after study initiation
2. Quality of Life (QoL)
Time frame: At 12 months after randomization.
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 10 Sep 2026.
- Description of the complete OMEC protocolLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Esophageal Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder 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.
Richard van Hillgersberg, MD, PhD contact
Peter van Rossum, MD, PhD principal investigator
Amsterdam UMC
Richard van Hillgersberg, MD, PhD principal investigator
UMC Utrecht
Hanneke van Laarhoven, MD, PhD, PhD principal investigator
Amsterdam UMC
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemotherapy, Targeted Systemic Therapy and Immunotherapy in people with Esophageal Cancer and Gastric (Stomach) Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 5 sites in 3 countries.
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 19 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 10 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 5 sites in Netherlands, Norway, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanneke van Laarhoven, MD, PhD, PhD (+31204444321, h.vanlaarhoven@amsterdamumc.nl), 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: the time interval from the date of randomization to the date of first occurrence of the following events (or last follow-up) up to 53 months after study initiation: Disease progression, death). 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 10 Sep 2026.