Recurrent Hepatocellular CarcinomaPhase 2NCT04663035
Ablation Plus Tislelizumab Versus Ablation Alone for Intrahepatic Recurrent Early Stage HCC
A Phase 2 study testing Tislelizumab and Ablation in people with Recurrent Hepatocellular Carcinoma, run by Ming Zhao at 1 site in China.
Trial summary
This is a randomized, controlled, phase 2 study to assess the efficacy and safety of ablation followed by tislelizumab versus ablation alone in patients with early recurrent hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Hepatocellular Carcinoma
- What is being tested?
- Tislelizumab and Ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2020to 18 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological diagnosed HCC.
- The recurrent lesions should meet the diagnostic and staging criteria of the Barcelona liver cancer clinical system (BCLC) recommended by the American Association of liver Diseases and the European Association of liver Diseases (AASLD/EASL). The specific diagnostic criteria for HCC are as follows:
- Intrahepatic lesions ≥ 1cm, with typical HCC findings in dynamic contrast-enhanced CT or MRI, that is, enhancement in arterial phase or decreased enhancement in portal phase.
- Intrahepatic lesions ≥ 1cm without typical imaging findings, the biopsy can be performed.
- Intrahepatic lesions < 1cm, ultrasound follow-up every 4 months, if the enlargement exceeds 1cm, then refer to standard I or II.
- If the intrahepatic recurrent lesions are diagnosed by the above criteria, BCLC-0/A stage can be performed as follows:
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- BCLC-0: single lesion < 2cm, Child-Pugh A (without ascites), and ECOG-PS 0. II.BCLC-A: single lesion ≥ 2cm, Child-Pugh A (without ascites), and ECOG-PS 0. III.BCLC-A stage: 2-3 lesions but all are less than 3cm. Child-Pugh A (without ascites), and ECOG-PS 0.
- The recurrence time of HCC should be between 3 and 12 months.
- Patients with recurrent HCC lesions should meet the indications of ablation treatment, as follows:
- Single lesion ≤ 5 cm; or. II. 2-3 lesions, all are less than 3cm; and. III. The location of the above lesions should be far away from the dangerous sites.
- 6. Life expectancy ≥ 12 months. 7. The laboratory test shall be completed within 7 days before the screening and the following criteria shall be met: I. Adequate hematologic function：
- WBC ≥ 2.0 x 109/L (stable, off any growth factor within 4 weeks of study drug administration)
- Neutrophils ≥ 1.5 x 109/L (stable, off any growth factor within 4 weeks of study drug administration)
- Platelets ≥ 60 x 109/L (transfusion to achieve this level is not permitted)
- Hemoglobin ≥ 80 g/L (may be transfused to meet this requirement)
- Adequate hepatic function:
- Serum Aspartate Aminotransferase (AST) < 8 X ULN
- Serum Alanine Aminotransferase (ALT) < 8 X ULN
- Serum total bilirubin < 3 mg/dL
- Serum albumin ≥ 2.8 g/dL
- Adequate coagulation function:
- a)Prothrombin time (PT)-international normalized ratio (INR)≤ 2.3 or PT < 6 seconds above control
- Adequate renal function:
- Creatinine Crack >40 mL/min (Cockcroft-Gault formula) a serum creatinine of < 1.5 × ULN
Who cannot join
- -Target lesion
- 1. Known fibrolamellar HCC, sarcomatous HCC, or mixed cholangiocarcinoma and HCC.
- 2. Patients who have undergone a liver transplant or those who are in the waiting list for liver transplantation.
- 3. With vascular invasion and extrahepatic metastases.
- General condition
- 1. Patients with cardiac pacemaker implantation. 2. Any history of hepatic encephalopathy. 3. Any prior (within 1 year) or current clinically significant ascites as measured by physical examination and that requires active paracentesis for control.
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- 4. Any history of clinically meaningful variceal bleeding within the last 3 months 5. Hepatitis B virus DNA copy number > 500 IU/mL. 6. Hepatitis D infection in subjects with hepatitis B. 7. Prior malignancy active within the previous 5 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, prostate cancer without evidence of PSA progression or carcinoma in situ such as the following: gastric, prostate, cervix, colon, melanoma, or breast for example.
- 8. Subjects with any active autoimmune disease or history of known or suspected autoimmune disease except for subjects with vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- 9. Uncontrolled or clinically significant cardiac disease. 10. Positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Previous / concomitant therapy
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti- CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
- Prior organ allograft or allogeneic bone marrow transplantation
- All toxicities attributed to prior anti-cancer therapy other than neuropathy, alopecia and fatigue must have resolved to Grade 1 (NCI CTCAE version 5.0) or baseline before administration of study drug. Subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae are permitted to enroll. Neuropathy must have resolved to Grade 2 (NCI CTCAE version 5.0).
- Active bacterial or fungal infections requiring systemic treatment within 7 days
- Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Minimally Invasive and Interventional Radiology, Liver Cancer Study and Service Group, Sun Yat-sen University Cancer Center,
Guangzhou, Guangdong, 500060
Ming Zhao, MD, 86-20-87343272, zhaoming@sysucc.org.cn
About this study
Official title: CT-guided Thermal Ablation Plus Tislelizumab Versus Ablation Alone for Intrahepatic Recurrent Early Stage Hepatocellular Carcinoma: a Randomized Controlled Phase II Clinical Trial
This is a randomized, controlled, phase 2 study to assess the efficacy and safety of ablation followed by tislelizumab versus ablation alone in patients with early recurrent hepatocellular carcinoma.
Read the detailed description
Ablation is one of the main treatments for early recurrent HCC, and its immune stimulation is expected to improve the efficacy of anti-PD-1 immune checkpoint inhibitor therapy. Tislelizumab is a new immunotherapy agent with independent intellectual property rights in China, which is highly efficient and safe. It is of great value to combine Tislelizumab with ablation to reduce the risk of recurrence in HCC patients. In this study, early-stage HCC patients with high risk of recurrence would be included and randomly assigned to receive ablation plus Tislelizumab or ablation alone. The tumor recurrence, overall survival and safety would be observed and recorded to analyze whether Tislelizumab can reduce the recurrence rate.
- Conditions
- Recurrent Hepatocellular Carcinoma
- Being tested
- Tislelizumab, Ablation
- Keywords
- Recurrent Hepatocellular Carcinoma, Ablation, Tislelizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Also called Tislelizumab Injection
200mg, iv. drip, Q3W. Tislelizumab will start within 3-7 days after ablation treatment. The longest course of treatment is 12 months.
AblationProcedure or surgery
After local anesthesia and intravenous sedative injection, the unipolar needle would be gradually inserted into the lesion and placed on the deepest edge of the lesion. The ablation electrode is a unipolar needle with a bare end of 2 or 3 cm (adjusted to tumor size). The ablation power is 150 watts (range from 100 to 200 watts). In general, the average ablation time for each lesion is about 12 minutes (ranging from 10 to 15 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Ablation Plus Tislelizumab | Experimental | Patients in this arm will receive ablation followed by tislelizumab, which will be started within 3-7 days after ablation until disease progression or intolerable toxicity, for 12 months. Receives: Drug: Tislelizumab; Procedure: Ablation |
| Ablation Alone | Active comparator | Patients in this group will receive ablation therapy and then enter the follow-up phase. Receives: Procedure: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year recurrence-free survival (RFS) rate
It is defined as the percentage of patients who achieve a time interval of 1 year of no disease recurrence (i.e., intrahepatic recurrence or extrahepatic metastasis) or death (by any cause) from date of enrollment, whichever occurs first.
Measured: 1 year
Secondary outcomes (7)
2-year recurrence-free survival (RFS) rate
It is defined as the percentage of patients who achieve a time interval of 2 year of no disease recurrence (i.e., intrahepatic recurrence or extrahepatic metastasis) or death (by any cause) from date of enrollment.
Measured: 2 years
3-year recurrence-free survival (RFS) rate
It is defined as the percentage of patients who achieve a time interval of 3 year of no disease recurrence (i.e., intrahepatic recurrence or extrahepatic metastasis) or death (by any cause) from date of enrollment.
Measured: 3 years
Overall survival (OS)
It is defined as the time from date of randomization to the date of death (due to any cause). Subjects who are alive will be censored at the last known alive dates.
Measured: 3 years
Time to Recurrence (TTR)
It is defined as the time between the date of enrollment and the date of first recurrence (i.e., intrahepatic recurrence or extrahepatic metastasis).
Measured: From date of randomization up to 5 years, approximately
Safety of ablation and ablation plus Tislelizumab
Incidence of adverse events (AEs), serious AEs, deaths and laboratory abnormalities in all treated patients.
Measured: From date of randomization up to 5 years, approximately
Biomarkers in tumor and peripheral blood to evaluate association with clinical efficacy and/or incidence of AEs.
Correlation of selected biomarkers with efficacy (RFS rate and OS) and safety (incidence of AEs) endpoints.
Measured: From date of randomization up to 5 years, approximately
Evaluate the patient's cancer-related QoL using the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaire (QLQ), the EORTC QLQ-C30 and the EORTC QLQ-HCC18.
Change in sub-scale and total scores of EORTC QLQ-C30 and EORTC QLQ- HCC18 from baseline through follow-up.
Measured: From date of randomization up to 5 years, approximately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start21 Dec 2020
- Primary completion18 Dec 2023 (estimated)
- Study completion18 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Recurrent 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ming Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ming Zhao, Sun Yat-sen University
- Investigators
- Ming Zhao, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663035
- Sponsor's protocol ID
- B2020-195-01
- Status last verified
- Mar 2023
- First submitted
- 9 Dec 2020
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lyu N, Kong Y, Li X, Mu L, Deng H, Chen H, He M, Lai J, Li J, Tang H, Lin Y, Zhao M. Ablation Reboots the Response in Advanced Hepatocellular Carcinoma With Stable or Atypical Response During PD-1 Therapy: A Proof-of-Concept Study. Front Oncol. 2020 Oct 9;10:580241. doi: 10.3389/fonc.2020.580241. eCollection 2020.
PubMed 33163408Pan T, Xie QK, Lv N, Li XS, Mu LW, Wu PH, Zhao M. Percutaneous CT-guided Radiofrequency Ablation for Lymph Node Oligometastases from Hepatocellular Carcinoma: A Propensity Score-matching Analysis. Radiology. 2017 Jan;282(1):259-270. doi: 10.1148/radiol.2016151807. Epub 2016 Jul 11.
PubMed 27399327Deng H, Kan A, Lyu N, Mu L, Han Y, Liu L, Zhang Y, Duan Y, Liao S, Li S, Xie Q, Gao T, Li Y, Zhang Z, Zhao M. Dual Vascular Endothelial Growth Factor Receptor and Fibroblast Growth Factor Receptor Inhibition Elicits Antitumor Immunity and Enhances Programmed Cell Death-1 Checkpoint Blockade in Hepatocellular Carcinoma. Liver Cancer. 2020 Jun;9(3):338-357. doi: 10.1159/000505695. Epub 2020 Feb 25.
PubMed 32647635Lyu N, Kong Y, Pan T, Mu L, Sun X, Li S, Deng H, Lai J, Zhao M. Survival benefits of computed tomography-guided thermal ablation for adrenal metastases from hepatocellular carcinoma. Int J Hyperthermia. 2019;36(1):1003-1011. doi: 10.1080/02656736.2019.1663279.
PubMed 31544545Mu L, Pan T, Lyu N, Sun L, Li S, Xie Q, Deng H, Wu P, Liu H, Zhao M. CT-guided percutaneous radiofrequency ablation for lung neoplasms adjacent to the pericardium. Lung Cancer. 2018 Aug;122:25-31. doi: 10.1016/j.lungcan.2018.05.004. Epub 2018 May 12.
PubMed 30032841
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-guided Thermal Ablation Plus Tislelizumab Versus Ablation Alone for Intrahepatic Recurrent Early Stage Hepatocellular Carcinoma: a Randomized Controlled Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT04663035
- Acronym / sponsor ID
- B2020-195-01
- Conditions
- Recurrent Hepatocellular Carcinoma
- Keywords
- Recurrent Hepatocellular Carcinoma, Ablation, Tislelizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ming ZhaoUniversity, hospital or other
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 18 Dec 2023 (estimated)
- Study completion
- 18 Dec 2025 (estimated)
- First posted
- 10 Dec 2020 (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.
This is a randomized, controlled, phase 2 study to assess the efficacy and safety of ablation followed by tislelizumab versus ablation alone in patients with early recurrent hepatocellular carcinoma.
Detailed description
Ablation is one of the main treatments for early recurrent HCC, and its immune stimulation is expected to improve the efficacy of anti-PD-1 immune checkpoint inhibitor therapy. Tislelizumab is a new immunotherapy agent with independent intellectual property rights in China, which is highly efficient and safe. It is of great value to combine Tislelizumab with ablation to reduce the risk of recurrence in HCC patients. In this study, early-stage HCC patients with high risk of recurrence would be included and randomly assigned to receive ablation plus Tislelizumab or ablation alone. The tumor recurrence, overall survival and safety would be observed and recorded to analyze whether Tislelizumab can reduce the recurrence rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablation Plus Tislelizumab | Experimental | Drug: Tislelizumab, Procedure: AblationPatients in this arm will receive ablation followed by tislelizumab, which will be started within 3-7 days after ablation until disease progression or intolerable toxicity, for 12 months. |
| Ablation Alone | Active comparator | Procedure: AblationPatients in this group will receive ablation therapy and then enter the follow-up phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Pathological diagnosed HCC.
- The recurrent lesions should meet the diagnostic and staging criteria of the Barcelona liver cancer clinical system (BCLC) recommended by the American Association of liver Diseases and the European Association of liver Diseases (AASLD/EASL). The specific diagnostic criteria for HCC are as follows:
- If the intrahepatic recurrent lesions are diagnosed by the above criteria, BCLC-0/A stage can be performed as follows:
- The recurrence time of HCC should be between 3 and 12 months.
- Patients with recurrent HCC lesions should meet the indications of ablation treatment, as follows:
Key exclusion criteria (16 listed)
- -Target lesion
- 1. Known fibrolamellar HCC, sarcomatous HCC, or mixed cholangiocarcinoma and HCC.
- 2. Patients who have undergone a liver transplant or those who are in the waiting list for liver transplantation.
- 3. With vascular invasion and extrahepatic metastases.
- 1. Patients with cardiac pacemaker implantation. 2. Any history of hepatic encephalopathy. 3. Any prior (within 1 year) or current clinically significant ascites as measured by physical examination and that requires active paracentesis for control.
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 |
|---|---|---|
| TislelizumabAlso: Tislelizumab Injection200mg, iv. drip, Q3W. Tislelizumab will start within 3-7 days after ablation treatment. The longest course of treatment is 12 months. | Drug | Ablation Plus Tislelizumab |
| AblationAfter local anesthesia and intravenous sedative injection, the unipolar needle would be gradually inserted into the lesion and placed on the deepest edge of the lesion. The ablation electrode is a unipolar needle with a bare end of 2 or 3 cm (adjusted to tumor size). The ablation power is 150 watts (range from 100 to 200 watts). In general, the average ablation time for each lesion is about 12 minutes (ranging from 10 to 15 minutes). | Procedure or surgery | Ablation Alone, Ablation Plus Tislelizumab |
Primary outcome
1-year recurrence-free survival (RFS) rate
Time frame: 1 year
It is defined as the percentage of patients who achieve a time interval of 1 year of no disease recurrence (i.e., intrahepatic recurrence or extrahepatic metastasis) or death (by any cause) from date of enrollment, whichever occurs first.
7 secondary outcomes
2-year recurrence-free survival (RFS) rate
Time frame: 2 years
3-year recurrence-free survival (RFS) rate
Time frame: 3 years
Overall survival (OS)
Time frame: 3 years
Time to Recurrence (TTR)
Time frame: From date of randomization up to 5 years, approximately
Safety of ablation and ablation plus Tislelizumab
Time frame: From date of randomization up to 5 years, approximately
Biomarkers in tumor and peripheral blood to evaluate association with clinical efficacy and/or incidence of AEs.
Time frame: From date of randomization up to 5 years, approximately
Evaluate the patient's cancer-related QoL using the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaire (QLQ), the EORTC QLQ-C30 and the EORTC QLQ-HCC18.
Time frame: From date of randomization up to 5 years, approximately
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Background: PubMed 33163408Lyu N, Kong Y, Li X, Mu L, Deng H, Chen H, He M, Lai J, Li J, Tang H, Lin Y, Zhao M. Ablation Reboots the Response in Advanced Hepatocellular Carcinoma With Stable or Atypical Response During PD-1 Therapy: A Proof-of-Concept Study. Front Oncol. 2020 Oct 9;10:580241. doi: 10.3389/fonc.2020.580241. eCollection 2020.
- Background: PubMed 27399327Pan T, Xie QK, Lv N, Li XS, Mu LW, Wu PH, Zhao M. Percutaneous CT-guided Radiofrequency Ablation for Lymph Node Oligometastases from Hepatocellular Carcinoma: A Propensity Score-matching Analysis. Radiology. 2017 Jan;282(1):259-270. doi: 10.1148/radiol.2016151807. Epub 2016 Jul 11.
- Background: PubMed 32647635Deng H, Kan A, Lyu N, Mu L, Han Y, Liu L, Zhang Y, Duan Y, Liao S, Li S, Xie Q, Gao T, Li Y, Zhang Z, Zhao M. Dual Vascular Endothelial Growth Factor Receptor and Fibroblast Growth Factor Receptor Inhibition Elicits Antitumor Immunity and Enhances Programmed Cell Death-1 Checkpoint Blockade in Hepatocellular Carcinoma. Liver Cancer. 2020 Jun;9(3):338-357. doi: 10.1159/000505695. Epub 2020 Feb 25.
- Background: PubMed 31544545Lyu N, Kong Y, Pan T, Mu L, Sun X, Li S, Deng H, Lai J, Zhao M. Survival benefits of computed tomography-guided thermal ablation for adrenal metastases from hepatocellular carcinoma. Int J Hyperthermia. 2019;36(1):1003-1011. doi: 10.1080/02656736.2019.1663279.
- Background: PubMed 30032841Mu L, Pan T, Lyu N, Sun L, Li S, Xie Q, Deng H, Wu P, Liu H, Zhao M. CT-guided percutaneous radiofrequency ablation for lung neoplasms adjacent to the pericardium. Lung Cancer. 2018 Aug;122:25-31. doi: 10.1016/j.lungcan.2018.05.004. Epub 2018 May 12.
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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.
Ming Zhao, MD principal investigator
Sun Yat-sen University
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 Tislelizumab and Ablation in people with Recurrent Hepatocellular Carcinoma, run by Ming Zhao 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 24 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: status not confirmed, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Zhao, MD (86-20-87343272, zhaoming@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year recurrence-free survival (RFS) rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04663035, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.