Intrahepatic CholangiocarcinomaPhase 2NCT01862315
Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC)
A Phase 2 study testing Floxuridine (FUDR), dexamethasone and Gemcitabine in people with Intrahepatic Cholangiocarcinoma and Peripheral Cholangiocarcinoma, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
Trial summary
The purpose of this study is to use both, liver pump treatment and systemic chemotherapy, to assess the effects this type of treatment has on the patient and the tumor. Liver pump treatment uses a metal pump that is surgically placed in the abdomen and gives chemotherapy directly to the liver. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma, Peripheral Cholangiocarcinoma, Cholangiolar Carcinoma
- What is being tested?
- Floxuridine (FUDR), dexamethasone and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2013to 18 Mar 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 21 years
- Histologically confirmed intrahepatic cholangiocarcinoma (also variously reported as peripheral cholangiocarcinoma, cholangiolar carcinoma or cholangiocellular carcinoma) (ICC). Confirmation of the diagnosis at MSKCC or at the enrolling institution must be obtained prior to initiation of protocol therapy.
- Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection.
- Radiographically measurable disease. Measurable disease is defined as disease that can be assessed with 2-dimensional measurements on a cross-sectional imaging. Minimum lesion size is 2cm in greatest diameter as per RECIST criteria.
- Disease must be considered unresectable at the time of preoperative evaluation.
- Presence of less than 70% liver involvement by cancer.
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- Patients may have failed ablative therapy
- Patient previously treated with systemic chemotherapy will be eligible
- KPS ≥ 60% and be considered candidates for general anesthesia, abdominal exploration and hepatic artery pump placement
- Patients with chronic hepatitis and/or cirrhosis are eligible, but must be Child-Pugh class A
- Patients must be able to read, understand and sign informed consent
- WBC ≥ 2,000 cells/mm3
- Platelet count ≥ 75,000/mm3
- Creatinine ≤ 1.8 mg/dl
- Total bilirubin < 1.5 mg/dl
Who cannot join
- Presence of distant metastatic disease. Patients will undergo radiographic evaluation to exclude the possibility of distant metastatic disease. For patients who have undergone pre- or postoperative biopsies that definitively diagnose ICC, the diagnostic studies may be modified at the discretion of the MSKCC Principal Investigator. Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection.
- Prior treatment with FUDR
- Prior external beam radiation therapy to the liver
- Diagnosis of sclerosing cholangitis
- Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis) surgically related ascites does not exclude the patient)
- Active infection
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- Pregnant or lactating women
- History of other malignancy within the past 3 years (except non-melanoma skin cancer)
- Life expectancy less than 12 weeks
- Inability to comply with study and/or followup procedures
- History of peripheral neuropathy (Note: this does not apply to Cohort 3)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: A Phase II Study of Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC)
The purpose of this study is to use both, liver pump treatment and systemic chemotherapy, to assess the effects this type of treatment has on the patient and the tumor. Liver pump treatment uses a metal pump that is surgically placed in the abdomen and gives chemotherapy directly to the liver. Systemic chemotherapy gives chemotherapy through a vein [intravenously (IV)] and treats the whole body. This type of treatment has been done before and had shown that people with both pump and systemic chemotherapy had improved results. The investigators hope that this combination of treatments improves the response to chemotherapy and reduces the spread of the disease.
Another purpose of this study is to learn the clinical importance of a specific type of MRI scan. The investigators would like to see if this type of MRI will help predict the response to the treatment and see if they could help the physician with their treatment plan. These scans will be done at specific time points.
Read more
The last purpose of this study is to learn more about how the tumor interacts with the chemotherapy. This will be done through a biopsy taken during surgery and blood draws at specific time points.
Permission from patients entering the study will be obtained to take normal and tumor liver biopsies at the time of surgery. These samples are voluntary and optional.
- Conditions
- Intrahepatic Cholangiocarcinoma, Peripheral Cholangiocarcinoma, Cholangiolar Carcinoma, Cholangiocellular Carcinoma
- Being tested
- Floxuridine (FUDR), dexamethasone, Gemcitabine, Oxaliplatin, MRI
- Keywords
- Hepatic Arterial Infusion (HAI), Floxuridine (FUDR), Dexamethasone (DEX), Gemcitabine, Oxaliplatin, 13-066
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Floxuridine (FUDR)Drug
dexamethasoneDrug
GemcitabineDrug
OxaliplatinDrug
MRIOther
Research blood drawsOther
These are optional
| Study group | Role | What they receive |
|---|---|---|
| No prior chemo or responded/stable with prior chemo | Experimental | All patients receive HAI FUDR ([0.12 mg/kg/day kg 30] / pump flow rate)\& dexamethasone ({1 mg/m2/day30} pump flow rate) on Day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care. Receives: Drug: Floxuridine (FUDR); Drug: dexamethasone; Drug: Gemcitabine; Drug: Oxaliplatin; Other: MRI; Other: Research blood draws |
| patients who have failed systemic therapy | Experimental | All patients receive HAI FUDR ([0.12 mg/kg/day kg 30] / pump flow rate)\& dexamethasone ({1 mg/m2/day 30}/ pump flow rate) on day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care. Receives: Drug: Floxuridine (FUDR); Drug: dexamethasone; Drug: Gemcitabine; Drug: Oxaliplatin; Other: MRI; Other: Research blood draws |
| pts who have had prior oxaliplatin & have existing neuropathy | Experimental | All patients receive will receive gemcitabine alone with HAI FUDR/Dex Gemcitabine (800 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter. Receives: Drug: dexamethasone; Drug: Gemcitabine; Other: MRI; Other: Research blood draws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival for Cohort 1
Treatment evaluation will be done using RECIST (version 1.1). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: 6 months
Progression Free Survival for Cohort 2
Treatment evaluation will be done using RECIST (version 1.1). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: 3 months
Response for Cohort 3
Treatment evaluation will be done using RECIST (version 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: 6 months
Secondary outcomes (2)
Overall Survival
This study will investigate DCE-MRI as potential imaging biomarkers and will measure tumor perfusion parameters and diffusion coefficients before initiating treatment and on follow-up MRI scans during treatment..
Measured: 1 year
Number of Participants Evaluated for Disease Progression After Initiation of HAI Placement
This study will investigate diffusion weighted imaging (DWI) as potential imaging biomarkers and will measure tumor perfusion parameters and diffusion coefficients before initiating treatment and on follow-up MRI scans during treatment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startMay 2013
- Primary completion18 Mar 2025
- Study completion18 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Jarnagin, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862315
- Sponsor's protocol ID
- 13-066
- Status last verified
- Mar 2025
- First submitted
- 20 May 2013
- Last updated
- 1 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Blair AB, Alobuia WM, Palta M, Raman SS, Levine MH, Benson AB 3rd, D'Angelica MI, Cloyd JM. Locoregional Treatment Options for Locally Advanced Intrahepatic Cholangiocarcinoma. J Natl Compr Canc Netw. 2025 Aug 14;23(9):e257085. doi: 10.6004/jnccn.2025.7085.
PubMed 40812353
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC)
- ClinicalTrials.gov ID
- NCT01862315
- Acronym / sponsor ID
- 13-066
- Conditions
- Intrahepatic Cholangiocarcinoma, Peripheral Cholangiocarcinoma, Cholangiolar Carcinoma, Cholangiocellular Carcinoma
- Keywords
- Hepatic Arterial Infusion (HAI), Floxuridine (FUDR), Dexamethasone (DEX), Gemcitabine, Oxaliplatin, 13-066
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 18 Mar 2025 (actual)
- First posted
- 24 May 2013 (estimated)
- Results
- Posted 1 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to use both, liver pump treatment and systemic chemotherapy, to assess the effects this type of treatment has on the patient and the tumor. Liver pump treatment uses a metal pump that is surgically placed in the abdomen and gives chemotherapy directly to the liver. Systemic chemotherapy gives chemotherapy through a vein [intravenously (IV)] and treats the whole body. This type of treatment has been done before and had shown that people with both pump and systemic chemotherapy had improved results. The investigators hope that this combination of treatments improves the response to chemotherapy and reduces the spread of the disease.
Another purpose of this study is to learn the clinical importance of a specific type of MRI scan. The investigators would like to see if this type of MRI will help predict the response to the treatment and see if they could help the physician with their treatment plan. These scans will be done at specific time points.
The last purpose of this study is to learn more about how the tumor interacts with the chemotherapy. This will be done through a biopsy taken during surgery and blood draws at specific time points.
Permission from patients entering the study will be obtained to take normal and tumor liver biopsies at the time of surgery. These samples are voluntary and optional.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No prior chemo or responded/stable with prior chemo | Experimental | Drug: Floxuridine (FUDR), Drug: dexamethasone, Drug: Gemcitabine, Drug: Oxaliplatin, Other: MRI, Other: Research blood drawsAll patients receive HAI FUDR ([0.12 mg/kg/day kg 30] / pump flow rate)\& dexamethasone ({1 mg/m2/day30} pump flow rate) on Day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care. |
| patients who have failed systemic therapy | Experimental | Drug: Floxuridine (FUDR), Drug: dexamethasone, Drug: Gemcitabine, Drug: Oxaliplatin, Other: MRI, Other: Research blood drawsAll patients receive HAI FUDR ([0.12 mg/kg/day kg 30] / pump flow rate)\& dexamethasone ({1 mg/m2/day 30}/ pump flow rate) on day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) \& Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 \& 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, \& then every 2 weeks thereafter. Clinical MRI examinations of the abdomen \& pelvis are obtained at baseline following surgery, prior to treatment initiation \& 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 \& 9 thereafter A non-contrast CT of chest, abdomen \& pelvis will also be obtained as part of routine clinical care. |
| pts who have had prior oxaliplatin & have existing neuropathy | Experimental | Drug: dexamethasone, Drug: Gemcitabine, Other: MRI, Other: Research blood drawsAll patients receive will receive gemcitabine alone with HAI FUDR/Dex Gemcitabine (800 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 21 years
- Histologically confirmed intrahepatic cholangiocarcinoma (also variously reported as peripheral cholangiocarcinoma, cholangiolar carcinoma or cholangiocellular carcinoma) (ICC). Confirmation of the diagnosis at MSKCC or at the enrolling institution must be obtained prior to initiation of protocol therapy.
- Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection.
- Radiographically measurable disease. Measurable disease is defined as disease that can be assessed with 2-dimensional measurements on a cross-sectional imaging. Minimum lesion size is 2cm in greatest diameter as per RECIST criteria.
- Disease must be considered unresectable at the time of preoperative evaluation.
Key exclusion criteria (11 listed)
- Presence of distant metastatic disease. Patients will undergo radiographic evaluation to exclude the possibility of distant metastatic disease. For patients who have undergone pre- or postoperative biopsies that definitively diagnose ICC, the diagnostic studies may be modified at the discretion of the MSKCC Principal Investigator. Clinical or radiographic evidence of metastatic disease to regional lymph nodes will be allowed, provided it is amenable to resection.
- Prior treatment with FUDR
- Prior external beam radiation therapy to the liver
- Diagnosis of sclerosing cholangitis
- Clinical evidence or portal hypertension (ascites, gastroesophageal varices, or portal vein thrombosis) surgically related ascites does not exclude the patient)
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 |
|---|---|---|
| Floxuridine (FUDR) | Drug | No prior chemo or responded/stable with prior chemo, patients who have failed systemic therapy |
| dexamethasone | Drug | No prior chemo or responded/stable with prior chemo, patients who have failed systemic therapy, pts who have had prior oxaliplatin & have existing neuropathy |
| Gemcitabine | Drug | No prior chemo or responded/stable with prior chemo, patients who have failed systemic therapy, pts who have had prior oxaliplatin & have existing neuropathy |
| Oxaliplatin | Drug | No prior chemo or responded/stable with prior chemo, patients who have failed systemic therapy |
| MRI | Other | No prior chemo or responded/stable with prior chemo, patients who have failed systemic therapy, pts who have had prior oxaliplatin & have existing neuropathy |
| Research blood drawsThese are optional | Other | No prior chemo or responded/stable with prior chemo, patients who have failed systemic therapy, pts who have had prior oxaliplatin & have existing neuropathy |
Primary outcome
Progression Free Survival for Cohort 1
Time frame: 6 months
Treatment evaluation will be done using RECIST (version 1.1). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Progression Free Survival for Cohort 2
Time frame: 3 months
Treatment evaluation will be done using RECIST (version 1.1). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Response for Cohort 3
Time frame: 6 months
Treatment evaluation will be done using RECIST (version 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
2 secondary outcomes
Overall Survival
Time frame: 1 year
Number of Participants Evaluated for Disease Progression After Initiation of HAI Placement
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40812353Blair AB, Alobuia WM, Palta M, Raman SS, Levine MH, Benson AB 3rd, D'Angelica MI, Cloyd JM. Locoregional Treatment Options for Locally Advanced Intrahepatic Cholangiocarcinoma. J Natl Compr Canc Netw. 2025 Aug 14;23(9):e257085. doi: 10.6004/jnccn.2025.7085.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
William Jarnagin, MD principal investigator
Memorial Sloan Kettering Cancer Center
6 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 Floxuridine (FUDR), dexamethasone and Gemcitabine in people with Intrahepatic Cholangiocarcinoma and Peripheral Cholangiocarcinoma, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.
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 15 inclusion and 11 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: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
Yes. Results are posted in the registry (first posted 1 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression Free Survival for Cohort 1 (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT01862315, which also lists 1 linked publication.
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 1 Jul 2026.