Liver CancerPhase 3NCT03164382
Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil/Leucovorin Versus Sorafenib in Advanced Hepatocellular Carcinoma
A Phase 3 study testing FOLFOX regimen and Sorafenib 200Mg Tab in people with Liver Cancer and Hepatic Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This trial was designed to investigate whether the survival outcome, response rate and safety of hepatic arterial infusion of oxaliplatin, fluorouracil/leucovorin regimens for patients with Barcelona-Clinic Liver Cancer (BCLC)-C stage hepatocellular carcinoma was superior than those of the standard treatment with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cancer, Hepatic Carcinoma
- What is being tested?
- FOLFOX regimen and Sorafenib 200Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to 30 Nov 2020
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained prior to any screening procedures.
- Cytohistological confirmation is required for diagnosis of HCC.
- Patients with advanced (unresectable and/or metastatic, stage C based on Barcelona-Clinic Liver Cancer [BCLC] staging classification) hepatocellular carcinoma which would not be suitable for treatment with loco-regional therapies or have progressed following locoregional therapy such as surgical resection, percutaneous hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy.
- At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1. Lesions previously treated with local therapy, such as radiation therapy, hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy should not be selected unless progression is noted at baseline, in which case, these lesions would be considered as non-target lesions.
- Current cirrhotic status of Child-Pugh class A-B, with no encephalopathy. Ascites controlled by diuretics is permitted in this study.
- Availability of a representative tumor tissue specimen (archival tumor tissue is allowed) at pre-screening.
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- Eastern Cooperative Oncology Group Scale for Assessment of Patient Performance Status ≤ 2.
- Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial.
- Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to procedure:
- Hemoglobin > 100g/L
- Absolute neutrophil count >3.0 ×109/L
- Neutrophil count > 1.5 ×109/L
- Platelet count ≥ 50.0 ×109/L
- Total bilirubin < 51 μmol/L
- Alanine transaminase (ALT) and aminotransferase (AST) < 5 x upper limit of normal
- Albumin > 28 g/L
- Prothrombin time (PT)-international normalized ratio (INR) < 2.3, or PT < 6 seconds above control
- Serum creatinine < 110 μmol/L
- Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
Who cannot join
- Received any prior systemic chemotherapy or molecular-targeted therapy for HCC such as sorafenib.
- Previous local therapy completed less than 4 weeks prior to the dosing and, if present any related acute toxicity > grade 1.
- Any contraindications for hepatic arterial infusion procedure:
- Impaired clotting test (platelet count < 60000/mm3, prothrombin activity < 50%).
- Renal failure / insufficiency requiring hemo-or peritoneal dialysis.
- Known severe atheromatosis.
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- Known uncontrolled blood hypertension (> 160/100 mm/Hg).
- Patients with any other malignancies within the last 3 years before study start.
- History of HCC tumor rupture.
- Patients with severe encephalopathy.
- Patients with known active bleeding (e.g. from GI ulcers, esophageal varices) within 2 months prior to baseline/screening visit or with history or evidence of inherited bleeding diathesis or coagulopathy.
- Clinically significant (CTC grade 3 or 4) venous or arterial thrombotic disease within past 6 months.
- History of cardiac disease:
- Congestive heart failure >New York Heart Association (NYHA) class 2 (refer to Appendix 13.9).
- Active coronary artery disease (CAD) (myocardial infarction more than 6 months prior to study entry is allowed).
- Cardiac arrhythmias (>Grade 2 NCI-CTCAE Version 4.0) which are poorly controlled with anti-arrhythmic therapy or requiring pace maker.
- Uncontrolled blood hypertension (> 160/100 mm/Hg).
- Serious, non-healing wound, ulcer, or bone fracture.
- History of abdominal fistula, GI perforation, or intra-abdominal abscess within past 6 months prior to study treatment.
- Clinically significant third space fluid accumulation (i.e., ascites requiring tapping despite use of diuretic or pleural effusion that either required tapping or is associated with shortness of breath).
- Patients who have undergone major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks of the start of protocol treatment.
- History of a bone marrow or solid organ transplant.
- Use of biologic response modifiers, such as G-colony stimulating factor (CSF), within 3 weeks prior to start of study drug. (G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator; however, they may not be substituted for a required dose reduction). Subjects taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 1 month prior to the study or during the study.
- Any other condition that would, in the Investigator's judgment, contraindicate patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable or unwilling to swallow medication, social/ psychological issues, etc.
- Unable to undergo either contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT).
- Known history of human immunodeficiency virus (HIV) seropositivity. HIV testing is not required as part of this study.
- Patients who have received any other investigational agents within a period of time that is less than the cycle length used for that treatment or equal to 4 weeks (whichever is shorter) prior to starting study drug and recovered from any side effects to grade 1 or less.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 7 days after permanently discontinuing HAIF and/or sorafenib treatment. Highly effective contraception methods include:
- Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- Male sterilization (at least 6 months prior to screening). For female patients on the study the vasectomized male partner should be the sole partner for that patient.
- Combination of any two of the following (a+b or a+c, or b+c):
- Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
- Placement of an intrauterine device or intrauterine system
- Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
- In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
- Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
- Sexually active males unless they use a condom during intercourse while receiving treatment and for 7 days after stopping study treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
- Subjects unable to suffer the discomfort of the HAI procedure (e.g. pain, claustrophobia, noise).
- Any contraindication for sorafenib, oxaliplatin, leucovorin, or fluorouracil administration.
- Any agents which could affect the absorption or pharmacokinetics of the study drugs.
- Known or suspected allergy to the investigational agents or any agent given in association with this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Minimally Invasive Interventional Division, Department of Medical Imaging and Interventional Radiology, Sun Yat-sen University Cancer Center,
Guangzhou, Guangdong, 500060
About this study
Official title: A Phase III Randomized Trial of Comparison of Survival Benefit of Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil/Leucovorin With Sorafenib for Patients With Barcelona-Clinic Liver Cancer (BCLC)-C Stage Hepatocellular Carcinoma
This trial was designed to investigate whether the survival outcome, response rate and safety of hepatic arterial infusion of oxaliplatin, fluorouracil/leucovorin regimens for patients with Barcelona-Clinic Liver Cancer (BCLC)-C stage hepatocellular carcinoma was superior than those of the standard treatment with sorafenib or not.
Read the detailed description
Hepatocellular carcinoma is the fifth most common malignancy worldwide. Advanced-stage disease is found in 25%-70% of HCC at diagnosis, with a median survival time of only 4.2-7.9 months due to limited treatment options. To date, sorafenib is the only standard treatment shown to extend overall survival for advanced hepatocellular carcinoma (Ad-HCC). However, low response rates, modest survival advantages and high-level heterogeneity of individual response, such limitations of sorafenib prohibit its widespread use in Ad-HCC and more alternative therapies are highly required at present.
Hepatic arterial infusion chemotherapy (HAIC) can provide chemotherapeutic agents to liver at higher concentration with lower toxicity and has been reported favorable results in advanced HCC. However, HAIC provides good but variable outcomes, with a response rate of 7-81% and median survival time of 6-15.9 months. The unstable response may attribute to complicate combinations based on various drugs, including fluorouracil (5-FU), cisplatin, doxorubicin, mitomycin, leucovorin and interferon. FOLFOX (oxaliplatin, 5-FU/leucovorin) was a regimen first used in colon cancer with liver metastasis and reported to be effective both by systemic and HAIC in amounts of clinical trials. A recent phase II study has shown that HAI of FOLFOX (HAIF) was well tolerated and effective in Ad-HCC. To the investigator's knowledge, no clinical studies have been developed on comparing the survival benefit of HAIF with sorafenib for patients with Ad-HCC. In this phase III trial, the investigators aimed to compare survival outcome, response rate and safety of HAIF with sorafenib in patients with Ad-HCC.
- Conditions
- Liver Cancer, Hepatic Carcinoma
- Being tested
- FOLFOX regimen, Sorafenib 200Mg Tab
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOX regimenDrug
Firstly, the femoral artery was percutaneously punctured using the Seldinger technique. Then, the catheter was inserted into the celiac trunk or superior mesenteric artery for arteriography. When more than one feeding artery of HCC was detected, the smaller arteries were embolized with gelatin sponge particles. A micro-catheter was inserted through the arterial catheter located at the common hepatic artery or proper hepatic arterial branch (feeding artery). When blood flows into the gastroduodenal artery was confirmed by micro-catheter angiography, the route was embolized with a coil or micro-coil to prevent reflux of chemotherapeutic drugs to the stomach and duodenum. The peripheral part of the catheter that was exposed to the outside of the body was covered with medical sterile gauze and fastened on the thigh's skin using medical rubberized fabric and bandage. Catheter insertion was repeatedly performed before every cycle of treatment.
Sorafenib 200Mg TabDrug
Sorafenib will be administered orally at the starting dose of 400 mg twice daily (800 mg total daily dose) to patients randomized to Arm S in accordance to its package insert or equivalent documentation. The 400 mg dose will be achieved by administration of 2 x 200 mg film-coated tablets, administered twice daily.
| Study group | Role | What they receive |
|---|---|---|
| HAIF group | Experimental | FOLFOX regimen: oxaliplatin 130 mg/m2 on day 1 from hour 0 to 3; leucovorin 200 mg/m2 from hour 3 to 5, fluorouracil 400 mg/m2 bolus at hour 5, and then fluorouracil 2,400 mg/m2 over 46 hours, via hepatic artery, once every 3 weeks. Receives: Drug: FOLFOX regimen |
| Sorafenib group | Active comparator | Sorafenib 200mg Tab, 400 mg twice per day orally. Treatment was given in 4-week cycles. Receives: Drug: Sorafenib 200Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival was the length of time after treatment until death from any cause.
Measured: 1 months
Secondary outcomes (2)
Time to Progression
Time to Progression was defined as the time from commencement of treatment to radiological disease progression.
Measured: 1 months
Time to Intrahepatic tumor Progression
Time to Intrahepatic tumor Progression was defined as the time from commencement of treatment to radiological intrahepatic tumor progression.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start1 Mar 2017
- Primary completion31 Oct 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Zhao, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164382
- Sponsor's protocol ID
- SB5010-2017-015
- Status last verified
- Dec 2020
- First submitted
- 21 May 2017
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen QF, Jiang X, Hu Y, Chen S, Lyu N, Zhao M. Interventional arterial chemotherapy versus sorafenib for advanced hepatocellular carcinoma in China: a health economic evaluation of open-label, randomised, phase 3 study. BMJ Open. 2025 May 27;15(5):e095508. doi: 10.1136/bmjopen-2024-095508.
PubMed 40436447Lyu N, Wang X, Li JB, Lai JF, Chen QF, Li SL, Deng HJ, He M, Mu LW, Zhao M. Arterial Chemotherapy of Oxaliplatin Plus Fluorouracil Versus Sorafenib in Advanced Hepatocellular Carcinoma: A Biomolecular Exploratory, Randomized, Phase III Trial (FOHAIC-1). J Clin Oncol. 2022 Feb 10;40(5):468-480. doi: 10.1200/JCO.21.01963. Epub 2021 Dec 14.
PubMed 34905388
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Trial of Comparison of Survival Benefit of Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil/Leucovorin With Sorafenib for Patients With Barcelona-Clinic Liver Cancer (BCLC)-C Stage Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03164382
- Acronym / sponsor ID
- SB5010-2017-015
- Conditions
- Liver Cancer, Hepatic Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 23 May 2017 (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 trial was designed to investigate whether the survival outcome, response rate and safety of hepatic arterial infusion of oxaliplatin, fluorouracil/leucovorin regimens for patients with Barcelona-Clinic Liver Cancer (BCLC)-C stage hepatocellular carcinoma was superior than those of the standard treatment with sorafenib or not.
Detailed description
Hepatocellular carcinoma is the fifth most common malignancy worldwide. Advanced-stage disease is found in 25%-70% of HCC at diagnosis, with a median survival time of only 4.2-7.9 months due to limited treatment options. To date, sorafenib is the only standard treatment shown to extend overall survival for advanced hepatocellular carcinoma (Ad-HCC). However, low response rates, modest survival advantages and high-level heterogeneity of individual response, such limitations of sorafenib prohibit its widespread use in Ad-HCC and more alternative therapies are highly required at present.
Hepatic arterial infusion chemotherapy (HAIC) can provide chemotherapeutic agents to liver at higher concentration with lower toxicity and has been reported favorable results in advanced HCC. However, HAIC provides good but variable outcomes, with a response rate of 7-81% and median survival time of 6-15.9 months. The unstable response may attribute to complicate combinations based on various drugs, including fluorouracil (5-FU), cisplatin, doxorubicin, mitomycin, leucovorin and interferon. FOLFOX (oxaliplatin, 5-FU/leucovorin) was a regimen first used in colon cancer with liver metastasis and reported to be effective both by systemic and HAIC in amounts of clinical trials. A recent phase II study has shown that HAI of FOLFOX (HAIF) was well tolerated and effective in Ad-HCC. To the investigator's knowledge, no clinical studies have been developed on comparing the survival benefit of HAIF with sorafenib for patients with Ad-HCC. In this phase III trial, the investigators aimed to compare survival outcome, response rate and safety of HAIF with sorafenib in patients with Ad-HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAIF group | Experimental | Drug: FOLFOX regimenFOLFOX regimen: oxaliplatin 130 mg/m2 on day 1 from hour 0 to 3; leucovorin 200 mg/m2 from hour 3 to 5, fluorouracil 400 mg/m2 bolus at hour 5, and then fluorouracil 2,400 mg/m2 over 46 hours, via hepatic artery, once every 3 weeks. |
| Sorafenib group | Active comparator | Drug: Sorafenib 200Mg TabSorafenib 200mg Tab, 400 mg twice per day orally. Treatment was given in 4-week cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Written informed consent must be obtained prior to any screening procedures.
- Cytohistological confirmation is required for diagnosis of HCC.
- Patients with advanced (unresectable and/or metastatic, stage C based on Barcelona-Clinic Liver Cancer [BCLC] staging classification) hepatocellular carcinoma which would not be suitable for treatment with loco-regional therapies or have progressed following locoregional therapy such as surgical resection, percutaneous hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy.
- At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1. Lesions previously treated with local therapy, such as radiation therapy, hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy should not be selected unless progression is noted at baseline, in which case, these lesions would be considered as non-target lesions.
- Current cirrhotic status of Child-Pugh class A-B, with no encephalopathy. Ascites controlled by diuretics is permitted in this study.
Key exclusion criteria (43 listed)
- Received any prior systemic chemotherapy or molecular-targeted therapy for HCC such as sorafenib.
- Previous local therapy completed less than 4 weeks prior to the dosing and, if present any related acute toxicity > grade 1.
- Any contraindications for hepatic arterial infusion procedure:
- Patients with any other malignancies within the last 3 years before study start.
- History of HCC tumor rupture.
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 |
|---|---|---|
| FOLFOX regimenFirstly, the femoral artery was percutaneously punctured using the Seldinger technique. Then, the catheter was inserted into the celiac trunk or superior mesenteric artery for arteriography. When more than one feeding artery of HCC was detected, the smaller arteries were embolized with gelatin sponge particles. A micro-catheter was inserted through the arterial catheter located at the common hepatic artery or proper hepatic arterial branch (feeding artery). When blood flows into the gastroduodenal artery was confirmed by micro-catheter angiography, the route was embolized with a coil or micro-coil to prevent reflux of chemotherapeutic drugs to the stomach and duodenum. The peripheral part of the catheter that was exposed to the outside of the body was covered with medical sterile gauze and fastened on the thigh's skin using medical rubberized fabric and bandage. Catheter insertion was repeatedly performed before every cycle of treatment. | Drug | HAIF group |
| Sorafenib 200Mg TabSorafenib will be administered orally at the starting dose of 400 mg twice daily (800 mg total daily dose) to patients randomized to Arm S in accordance to its package insert or equivalent documentation. The 400 mg dose will be achieved by administration of 2 x 200 mg film-coated tablets, administered twice daily. | Drug | Sorafenib group |
Primary outcome
Overall survival
Time frame: 1 months
Overall survival was the length of time after treatment until death from any cause.
2 secondary outcomes
Time to Progression
Time frame: 1 months
Time to Intrahepatic tumor Progression
Time frame: 1 months
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 16 Dec 2020.
- Derived from this study: PubMed 40436447Chen QF, Jiang X, Hu Y, Chen S, Lyu N, Zhao M. Interventional arterial chemotherapy versus sorafenib for advanced hepatocellular carcinoma in China: a health economic evaluation of open-label, randomised, phase 3 study. BMJ Open. 2025 May 27;15(5):e095508. doi: 10.1136/bmjopen-2024-095508.
- Derived from this study: PubMed 34905388Lyu N, Wang X, Li JB, Lai JF, Chen QF, Li SL, Deng HJ, He M, Mu LW, Zhao M. Arterial Chemotherapy of Oxaliplatin Plus Fluorouracil Versus Sorafenib in Advanced Hepatocellular Carcinoma: A Biomolecular Exploratory, Randomized, Phase III Trial (FOHAIC-1). J Clin Oncol. 2022 Feb 10;40(5):468-480. doi: 10.1200/JCO.21.01963. Epub 2021 Dec 14.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FOLFOX regimen and Sorafenib 200Mg Tab in people with Liver Cancer and Hepatic Carcinoma, run by Sun Yat-sen University 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 19 inclusion and 43 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 16 Dec 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Overall survival (time frame: 1 months). 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 NCT03164382, which also lists 2 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 16 Dec 2020.