HepatoCellular CarcinomaPhase 2NCT03033446
Study of Y90-Radioembolization With Nivolumab in Asians With Hepatocellular Carcinoma
A Phase 2 study testing Y-90 Radioembolization and Nivolumab in people with HepatoCellular Carcinoma, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial summary
The purpose of this study is to evaluate the effect of liver-localised radioembolization and nivolumab on liver cancer. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- HepatoCellular Carcinoma
- What is being tested?
- Y-90 Radioembolization and Nivolumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Dec 2016to 26 Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hepatocellular carcinoma (HCC) that is not suitable for resection or liver transplant, who are planned for Y90 radioembolization as per institutional practice.
- Patients must have measurable disease with target lesion in liver, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
- Diagnosis of HCC confirmed by histology/cytology or clinically by AASLD criteria in cirrhotic subjects. Patients without cirrhosis require histological confirmation of diagnosis
- No prior Y90 radioembolization therapy. Prior local therapies, such as surgery, hepatic artery embolization/chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoabalastion is allowed, if the index lesion(s) remains outside of the treatment field or has progressed since prior treatment. Local therapy must have been completed at least 4 weeks prior to the baseline scan
- Age ≥ 21 years.
- ECOG performance status ≤ 2
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- Life expectancy of greater than 3 months
- Only patients with Child-Pugh score for liver cirrhosis of A (sum of scores for five parameters: 5-6) will be allowed into this trial
- Subjects with HBV infection must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy. Both HBeAg positive and negative subjects will be included.
- Patients must have lesions in the liver that are amenable to CT-guided liver biopsy
- Patients must have normal organ and marrow function as defined below:
- Haemoglobin ≥ 8.5g/dL
- Absolute Neutrophil Count ≥ 1.5 x 10^9/L
- Platelets ≥ 50 x 10^9/L
- Total Bilirubin < 3 mg/dL
- AST(SGOT)/ALT (SGPT) ≤ 3 x ULN
- Creatinine ≤ 1.5 x ULN or measured/calculated Creatinine Clearance (CrCl) ≥ 60 ml/min
- Ability to understand and the willingness to sign a written informed consent document.
- Any surgery must be more than 28 days before start of study drug and any surgical wounds must be completely healed
- Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to receiving the first dose of study medication, and must agree to adequate contraception use from time of signing the informed consent through to 120 days after the last dose of the study drug. Male subjects must agree to adequate contraception use from time of signing the informed consent through 120 days after the last dose of the study drug.
Who cannot join
- Patients are excluded if they are receiving any other investigational agents or using an investigational device within 4 weeks of first dose of treatment. Patients are excluded if they are receiving other systemic therapy within 2 weeks of first dose of treatment.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Prior use of anti-PD1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any drug specifically targeted T-cell costimulatory checkpoint pathways
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects with any active autoimmune disease or history of known or suspected autoimmune disease requiring systemic therapy within the past 2 years, except for subjects with vitiligo, resolved childhood asthma/atopy or euthyroid patients with a history of Grave's disease (subjects with suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to randomization). Replacement therapy (e.g. with thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency etc) is not considered a form of systemic treatment
- Pregnant women or breastfeeding mothers are excluded from this study because of the potential risks to the foetus or baby. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
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- Diagnosis of immunodeficiency, including HIV/AIDS
- Prior organ allograft or allogeneic bone marrow transplantation
- History of severe hypersensitivity reactions to other monoclonal antibodies.
- Prisoners or subjects who are involuntarily incarcerated
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
- Inability to comply with restrictions and prohibited activities/treatments in this study
- Chronic treatment with systemic steroids or other immunosuppressive agent.
- Subjects with concomitant second malignancies (except adequately treated non-melanomatous skin cancers, in situ cervical cancers, localized prostate cancer or in situ breast cancer) are excluded unless a complete remission was achieved at least 3 years prior to study entry and no additional therapy is required or anticipated to be required
- Prior radiation therapy to the liver or upper abdomen
- Inability to undergo Y-90 radioembolisation due to inability to cathterise the hepatic artery, portal vein thrombosis/occlusion limiting the ability to perform selective infusion, Tc-99M MAA scan showing unfavourable shunt fraction between the liver and pulmonary parenchyma, any other contraindications to RE as determined by the interventional radiologist (e.g. other anatomic variants precluding safe administration of Y90, severe peripheral vascular disease, uncorrectable coagulopathy etc)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Open-Label, Single Centre, Non-Randomised Trial Of Y90-Radioembolization In Combination With Nivolumab In Asian Patients With Advanced Hepatocellular Carcinoma
The purpose of this study is to evaluate the effect of liver-localised radioembolization and nivolumab on liver cancer.
Read the detailed description
The hypothesis is that liver-localized radioembolization will stimulate tumour and/or HBV specific T cell responses that are associated with favourable patient outcomes and that can be boosted using nivolumab anti-PD1 checkpoint blockade immunotherapy.
Primary objective
To evaluate the response rates of Y90 radioembolization in combination with nivolumab in HCC
Secondary objectives
- To evaluate time to response, response duration, time to treatment progression and sites of progression when RE is combined with nivolumab
- To assess progression free survival and overall survival when RE is combined with nivolumab
- To assess the quality of life using the FACT-HEP score and EORTC QLQ-C30
- To assess the safety and tolerability of the combination of RE and nivolumab
Exploratory objectives
- To evaluate the relationship between tumor biopsy PD-L1 expression and response to treatment with Y90 radioembolization in combination with nivolumab
- To assess relationship between blood lymphocyte (e.g., T cell) activation and phenotypic profiles with response to treatment with Y90 radioembolization in combination with nivolumab, using mass cytometry and fluorescence flow cytometry.
- To assess relationship between HCC tumour mutational burden and response to treatment with Y90 radioembolization in combination with nivolumab using whole-exome sequencing of tumour biopsy samples
- Where possible, to evaluate antigen-specific T cell responses to known HBV, HCC tumour (including candidate mutation-derived tumour neo-antigens) and other unrelated antigens (e.g. CMV, EBV, Influenza) in the blood and to assess kinetic changes in these responses associated with response to treatment with Y90 radioembolization in combination with nivolumab using mass cytometry and fluorescence flow cytometry.
Administration of study drug The first dose of nivolumab will be administered 21 days (+/- 3 days) after completion of RE. [The dose of Yttrium-90 will be determined as per institution norm by the Nuclear Medicine physician, based on factors such as the subject's Body Surface Area (BSA), the size of the tumour within the liver, and any dose modifications required for percent lung shunting between 10 - 20% on the Tc-99MMA scan].
The dose given will be intravenous 240mg absolute over 30 minutes. Subsequent doses of nivolumab will be administered in the outpatient setting at NCCS. After the first dose, intravenous nivolumab 240mg will be given every 2 weeks.
A US or CT guided liver biopsy will be conducted by an interventional radiologist on C1D8 Subjects will be assessed for the following at EVERY visit: physical examination, ECOG status, vital signs, Child-Pugh score and ALBI score CT or MRI scans to assess response to treatment will be done before cycle 4, 8, 12 and then after every 12 weeks thereafter (±7 days).
FACT-HEP and EORTC QLQ C30 version 3.0 questionnaire at cycle 4 and 8.
Follow-Up Visit will be done 2-3 months after last dose. Survival updates will be obtained by phone every 3-4 months after the follow-up visit and any new anti-cancer treatment given to the subject will be recorded.
- Conditions
- HepatoCellular Carcinoma
- Being tested
- Y-90 Radioembolization, Nivolumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-90 RadioembolizationRadiation
Also called Selective Internal Radiation Therapy
Dose of Yttrium-90 is determined based on BSA, size of liver tumor, and dose modifications required for percent lung shunting between 10-20% on the Tc-99MMA scan
NivolumabDrug
Also called Opdivo
21 days after Radioembolization, 240mg of IV Nivolumab over 30 minutes will be administered every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Y90-Radioembolization and Nivolumab | Experimental | Not described Receives: Radiation: Y-90 Radioembolization; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Measured: Tumour assessment at 8 weeks
Secondary outcomes (8)
Time to Response
Measured: From date of first dose with Y90 Radioemolization (RE) until best overall response of Complete Response (CR) or Partial Response (PR) is achieved, up to 12 weeks after last dose of Nivolumab
Duration of Response
Measured: From date of first assessment of CR or PR until the first date that progressive disease or death is documented, up to 2 years
Time to Progression
Measured: From date of first dose with Y90 RE until the first date that progressive disease is documented, up to 12 weeks after last dose of Nivolumab
Progression Free Survival
Measured: From date of first dose with Y90 RE until tumour progression, or death from any cause, up to 12 weeks after last dose of Nivolumab
Overall Survival
Measured: From date of first dose with Y90 RE until death from any cause, up to 2 years
Quality of Life using the FACT-HEP score
Measured: From date of screening until 3 months after last dose of Nivolumab
Quality of Life using EORTC QLQ-C30
Measured: From date of screening until 3 months after last dose of Nivolumab
Adverse events from the combination of RE and nivolumab assessed by NCI CTCAE v4.0
Measured: While receiving study agent and up to 100 days after last dose of Nivolumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start20 Dec 2016
- Primary completion31 Aug 2019
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HepatoCellular CarcinomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Wai-Meng TAI, MD, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033446
- Sponsor's protocol ID
- CA209-678
- Status last verified
- May 2026
- First submitted
- 18 Jan 2017
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Tai D, Loke K, Gogna A, Kaya NA, Tan SH, Hennedige T, Ng D, Irani F, Lee J, Lim JQ, Too CW, Ng MCH, Tham CK, Lam J, Koo SL, Chong HS, Goh GB, Huang HL, Venkatanarasimha N, Lo R, Chow PKH, Goh BKP, Chung A, Toh HC, Thng CH, Lim TKH, Yeong J, Zhai W, Chan CY, Choo SP. Radioembolisation with Y90-resin microspheres followed by nivolumab for advanced hepatocellular carcinoma (CA 209-678): a single arm, single centre, phase 2 trial. Lancet Gastroenterol Hepatol. 2021 Dec;6(12):1025-1035. doi: 10.1016/S2468-1253(21)00305-8. Epub 2021 Oct 23.
PubMed 34695377
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open-Label, Single Centre, Non-Randomised Trial Of Y90-Radioembolization In Combination With Nivolumab In Asian Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03033446
- Acronym / sponsor ID
- CA209-678
- Conditions
- HepatoCellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 26 Jan 2017 (estimated)
- 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 purpose of this study is to evaluate the effect of liver-localised radioembolization and nivolumab on liver cancer.
Detailed description
The hypothesis is that liver-localized radioembolization will stimulate tumour and/or HBV specific T cell responses that are associated with favourable patient outcomes and that can be boosted using nivolumab anti-PD1 checkpoint blockade immunotherapy.
Primary objective
To evaluate the response rates of Y90 radioembolization in combination with nivolumab in HCC
Secondary objectives
- To evaluate time to response, response duration, time to treatment progression and sites of progression when RE is combined with nivolumab
- To assess progression free survival and overall survival when RE is combined with nivolumab
- To assess the quality of life using the FACT-HEP score and EORTC QLQ-C30
- To assess the safety and tolerability of the combination of RE and nivolumab
Exploratory objectives
- To evaluate the relationship between tumor biopsy PD-L1 expression and response to treatment with Y90 radioembolization in combination with nivolumab
- To assess relationship between blood lymphocyte (e.g., T cell) activation and phenotypic profiles with response to treatment with Y90 radioembolization in combination with nivolumab, using mass cytometry and fluorescence flow cytometry.
- To assess relationship between HCC tumour mutational burden and response to treatment with Y90 radioembolization in combination with nivolumab using whole-exome sequencing of tumour biopsy samples
- Where possible, to evaluate antigen-specific T cell responses to known HBV, HCC tumour (including candidate mutation-derived tumour neo-antigens) and other unrelated antigens (e.g. CMV, EBV, Influenza) in the blood and to assess kinetic changes in these responses associated with response to treatment with Y90 radioembolization in combination with nivolumab using mass cytometry and fluorescence flow cytometry.
Administration of study drug The first dose of nivolumab will be administered 21 days (+/- 3 days) after completion of RE. [The dose of Yttrium-90 will be determined as per institution norm by the Nuclear Medicine physician, based on factors such as the subject's Body Surface Area (BSA), the size of the tumour within the liver, and any dose modifications required for percent lung shunting between 10 - 20% on the Tc-99MMA scan].
The dose given will be intravenous 240mg absolute over 30 minutes. Subsequent doses of nivolumab will be administered in the outpatient setting at NCCS. After the first dose, intravenous nivolumab 240mg will be given every 2 weeks.
A US or CT guided liver biopsy will be conducted by an interventional radiologist on C1D8 Subjects will be assessed for the following at EVERY visit: physical examination, ECOG status, vital signs, Child-Pugh score and ALBI score CT or MRI scans to assess response to treatment will be done before cycle 4, 8, 12 and then after every 12 weeks thereafter (±7 days).
FACT-HEP and EORTC QLQ C30 version 3.0 questionnaire at cycle 4 and 8.
Follow-Up Visit will be done 2-3 months after last dose. Survival updates will be obtained by phone every 3-4 months after the follow-up visit and any new anti-cancer treatment given to the subject will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Y90-Radioembolization and Nivolumab | Experimental | Radiation: Y-90 Radioembolization, Drug: Nivolumab |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients with hepatocellular carcinoma (HCC) that is not suitable for resection or liver transplant, who are planned for Y90 radioembolization as per institutional practice.
- Patients must have measurable disease with target lesion in liver, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
- Diagnosis of HCC confirmed by histology/cytology or clinically by AASLD criteria in cirrhotic subjects. Patients without cirrhosis require histological confirmation of diagnosis
- No prior Y90 radioembolization therapy. Prior local therapies, such as surgery, hepatic artery embolization/chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoabalastion is allowed, if the index lesion(s) remains outside of the treatment field or has progressed since prior treatment. Local therapy must have been completed at least 4 weeks prior to the baseline scan
- Age ≥ 21 years.
Key exclusion criteria (16 listed)
- Patients are excluded if they are receiving any other investigational agents or using an investigational device within 4 weeks of first dose of treatment. Patients are excluded if they are receiving other systemic therapy within 2 weeks of first dose of treatment.
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Prior use of anti-PD1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any drug specifically targeted T-cell costimulatory checkpoint pathways
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects with any active autoimmune disease or history of known or suspected autoimmune disease requiring systemic therapy within the past 2 years, except for subjects with vitiligo, resolved childhood asthma/atopy or euthyroid patients with a history of Grave's disease (subjects with suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to randomization). Replacement therapy (e.g. with thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency etc) is not considered a form of systemic treatment
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 |
|---|---|---|
| Y-90 RadioembolizationAlso: Selective Internal Radiation TherapyDose of Yttrium-90 is determined based on BSA, size of liver tumor, and dose modifications required for percent lung shunting between 10-20% on the Tc-99MMA scan | Radiation | Y90-Radioembolization and Nivolumab |
| NivolumabAlso: Opdivo21 days after Radioembolization, 240mg of IV Nivolumab over 30 minutes will be administered every 2 weeks | Drug | Y90-Radioembolization and Nivolumab |
Primary outcome
Response Rate
Time frame: Tumour assessment at 8 weeks
8 secondary outcomes
Time to Response
Time frame: From date of first dose with Y90 Radioemolization (RE) until best overall response of Complete Response (CR) or Partial Response (PR) is achieved, up to 12 weeks after last dose of Nivolumab
Duration of Response
Time frame: From date of first assessment of CR or PR until the first date that progressive disease or death is documented, up to 2 years
Time to Progression
Time frame: From date of first dose with Y90 RE until the first date that progressive disease is documented, up to 12 weeks after last dose of Nivolumab
Progression Free Survival
Time frame: From date of first dose with Y90 RE until tumour progression, or death from any cause, up to 12 weeks after last dose of Nivolumab
Overall Survival
Time frame: From date of first dose with Y90 RE until death from any cause, up to 2 years
Quality of Life using the FACT-HEP score
Time frame: From date of screening until 3 months after last dose of Nivolumab
Quality of Life using EORTC QLQ-C30
Time frame: From date of screening until 3 months after last dose of Nivolumab
Adverse events from the combination of RE and nivolumab assessed by NCI CTCAE v4.0
Time frame: While receiving study agent and up to 100 days after last dose of Nivolumab
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Derived from this study: PubMed 34695377Tai D, Loke K, Gogna A, Kaya NA, Tan SH, Hennedige T, Ng D, Irani F, Lee J, Lim JQ, Too CW, Ng MCH, Tham CK, Lam J, Koo SL, Chong HS, Goh GB, Huang HL, Venkatanarasimha N, Lo R, Chow PKH, Goh BKP, Chung A, Toh HC, Thng CH, Lim TKH, Yeong J, Zhai W, Chan CY, Choo SP. Radioembolisation with Y90-resin microspheres followed by nivolumab for advanced hepatocellular carcinoma (CA 209-678): a single arm, single centre, phase 2 trial. Lancet Gastroenterol Hepatol. 2021 Dec;6(12):1025-1035. doi: 10.1016/S2468-1253(21)00305-8. Epub 2021 Oct 23.
- 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.
David Wai-Meng TAI, MD principal investigator
National Cancer Centre, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Y-90 Radioembolization and Nivolumab in people with HepatoCellular Carcinoma, run by National Cancer Centre, Singapore at 1 site in Singapore.
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 20 inclusion and 16 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 13 May 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 Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response Rate (time frame: Tumour assessment at 8 weeks). 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 NCT03033446, 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 13 May 2026.