Hepatocellular CarcinomaPhase 4SOONNCT01997957
A RCT of Oral S-1 in Combination With Sequential HAIC of Oxaliplatin After TACE in Patients With Advanced HCC
A Phase 4 study testing S-1 in people with Hepatocellular Carcinoma, run by Zhu Xu at 1 site in China.
Trial summary
Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world and causes death of about 600000~1000000 people each year. Since 1990s, hepatic carcinoma has become the second carcinoma killer in China. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- S-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Sep 2016
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signing the informed consent form;
- Diagnosed with HCC
- Patients with hepatic cirrhosis must comply with AASLD (American Association for the Study of Liver Diseases) diagnostic criteria:
- Typical radiological examination (ultrasonography, CT or MRI) manifestations: dynamic enhanced examination shows arterial-phase rapid heterogeneous enhancement and reduced venous-phase or delayed-phase rapid enhancement of space occupation in liver;
- If the diameter of space occupation in liver is ≥2cm, the diagnosis can be established if any of radiological examinations shows the above HCC characteristics;
- If the diameter of space occupation in liver is 1-2cm, the diagnosis can be established only when two radiological examinations show the above HCC characteristics;
Show all 27Show fewer
- If the diameter of space occupation in liver is≤1cm, histopathological examination is needed for establishing the diagnosis.
- Histopathological examination is needed for establishing the diagnosis for patients without hepatic cirrhosis.
- Stage Barcelona C
- Grade A or B Child-Pugh score
- ECOG PS score is 0-1
- At least one measurable focus in liver according to (M) RECIST 1.0 criteria
- Male or female, age>18
- Can orally take drugs
- Anticipated survival≥12 weeks
- Pregnancy test of women at child-bearing ages must be negative within the 7 days before treatment
- Male or female patients included must take effective contraceptive measures during the study period and within 4 weeks after completion of the study
- Within the 7 days before inclusion, bone marrow, liver and kidney functions must satisfy the following requirements:
- Hemoglobin≥ 90 g/L
- Absolute neutrophil count (ANC) >1,500/mm3
- Platelet count≥ 80x109/L
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 times the upper normal limit (UNL)
- Total bilirubin < 3UNL
- Alkaline phosphatase < 4UNL
- Serum creatinine < 1.5 UNL
- Amylase and lipase < 2 UNL
- INR<2.3 or PPT< 1.5 UNL (Patients who are accepting Warfarin or heparin anticoagulant therapy may be included if no evidence is available proving the above indicators are abnormal, but intense monitoring must be exercised. Tests shall be carried out at least once per week until stable INR.)
Who cannot join
- Early or middle-stage primary HCC
- Any contraindication of TACE therapy
- Known hepatofugal blood flow
- Known portal-systemic shunt
- Abnormal coagulation test (PLT<6000/mm3, thrombogen activity<50%)
- Renal failure or renal insufficiency necessitating dialysis
Show all 36Show fewer
- Serious atherosclerosis
- Foci having undergone local treatment (e.g. resection, RFA, PEI or argon-helium cryoablation) cannot be used as the target foci
- Local therapy or systemic chemotherapy within 4 weeks before inclusion or during the study period
- Acute toxic reaction of CTC grade AE2 or above in any local treatment before inclusion
- History of heart diseases:
- Congestive heart failure of NYHA grade 2 above
- Symptomatic coronary artery disease
- Arrhythmia needing treatment with β blockers or drugs other than digoxin
- uncontrollable hypertension
- HIV infection or AIDS-related diseases
- Serious active infections other than hepatitis B and hepatitis C (NCI-CTCAE 4.0 grade 2 above)
- Gastrointestinal hemorrhage event within 4 weeks before inclusion
- Thrombogenesis or embolism event within 6 months before inclusion, e.g. cerebral vascular accidents (including TIA), deep venous thrombogenesis or pulmonary embolisms
- Past or present history of concomitant tumors completely different from HCC in primary lesions or histology, excluding head and neck carcinoma in situ, cured basal cell carcinoma, superficial bladder carcinoma (Ta, Tis, T1) and tumors having been cured 3 years before inclusion
- Drug abuse, or psychological or mental diseases that may interfere with the study compliance
- Known or suspected allergy to the study drug or concomitant medications
- Contraindications of S-1
- Pregnancy or lactation
- Any disease that may affect evaluation of the study drug
- Any instability or condition that may impair the patient's safety and compliance in the study
- Gastrointestinal diseases affecting absorption or pharmacokinetics
- Conditions restricting the patient from taking drugs orally, including serious upper gastrointestinal obstruction
- Having accepted TACE before inclusion
- Having taken S-1 before inclusion
- Having accepted liver radiotherapy before inclusion or during the study period
- Having accepted biological regulators, e.g. G-CSF, within the 3 weeks before inclusion
- Having accepted autologous bone marrow transplantation or stem cell transplantation within 1 year before inclusion
- History of homoplastic transplantation
- Any drug that may affect absorption or pharmacokinetics of the study drug
- Poor compliance considered by the investigator
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Zhu Xu, Master, 0086-10-88195476, zhux387@263.net
Zhu Xu, Master
About this study
Official title: A Randomized Controled Trial of Oral S-1 in Combination With Sequential Hepatic Arterial Infusion of Oxaliplatin After Transarterial Chemoembolization in Patients With Advanced Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world and causes death of about 600000~1000000 people each year. Since 1990s, hepatic carcinoma has become the second carcinoma killer in China. Surgical resection or liver transplantation is the only method possibly able to cure hepatic carcinoma. However, due to multiple tumors or poor hepatic function reserve in cirrhosis, surgical treatment is suitable for only a small portion of patients (11.9%-30.1%). Therefore, in clinical practice, transarterial chemoembolization (TACE) or transarterial embolization (TAE) is a preferential and standard treatment of unresectable advanced hepatic carcinoma and has notable advantages in controlling local tumors of the liver. Hepatic arterial infusion of oxaliplatin after TACE can significantly increase the local doses of chemotherapeutic agents in the liver, kill micrometastases and residual foci after embolization and demonstrate outstanding efficacy for treating concomitant portal and hepatic vein tumor thrombi. S-1 is a chemotherapeutic agent with convenient use and definite efficacy and, when used concomitantly with TACE, theoretically can not only effectively control intrahepatic foci but also prevent and control extrahepatic metastatic foci. However, this hasn't been verified in clinical application. This study is intended to investigate efficacy and safety of the combination treatment so as to provide a more effective and safety way for treating patients with advanced hepatic carcinoma (Barcelona stage-C patients with concomitant portal vein tumor thrombi or extrahepatic metastasis).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- S-1
- Keywords
- Hepatocellular Carcinoma, Transarterial Chemoembolization, Hepatic Arterial Infusion Chemotherapy, Efficacy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1Drug
Begin oral administration of S-1 from the 2nd day after TACE therapy plus arterial indwelling catheter chemotherapy (Oxaliplatin)
| Study group | Role | What they receive |
|---|---|---|
| TACE+HAIC-OXA+S-1 | Experimental | Not described Receives: Drug: S-1 |
| TACE+HAIC-OXA | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression(TTP)
Time to clinically definite disease progression
Measured: Up to 2 years
Secondary outcomes (4)
Overall survival(OS)
Measured: Up to 2 years
Response rate (RR)
The percentage of patients showing partial or complete response to the given treatment
Measured: Up to 2 years
Disease Control Rate (DCR)
The percentage of patients showing partial or complete response or stable disease to the given treatment
Measured: Up to 2 years
Number of Participants with Serious and Non-Serious Adverse Events
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhu Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhu Xu, Peking University Cancer Hospital & Institute
- Investigators
- Zhu Xu, Master, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997957
- Sponsor's protocol ID
- OXALI_L_06366
- Acronym
- SOON
- Status last verified
- Nov 2013
- First submitted
- 20 Nov 2013
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controled Trial of Oral S-1 in Combination With Sequential Hepatic Arterial Infusion of Oxaliplatin After Transarterial Chemoembolization in Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT01997957
- Acronym / sponsor ID
- SOON / OXALI_L_06366
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Transarterial Chemoembolization, Hepatic Arterial Infusion Chemotherapy, Efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Zhu XuUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2016 (estimated)
- First posted
- 28 Nov 2013 (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.
Hepatocellular carcinoma (HCC) is one of the most commonly malignant tumors around the world and causes death of about 600000~1000000 people each year. Since 1990s, hepatic carcinoma has become the second carcinoma killer in China. Surgical resection or liver transplantation is the only method possibly able to cure hepatic carcinoma. However, due to multiple tumors or poor hepatic function reserve in cirrhosis, surgical treatment is suitable for only a small portion of patients (11.9%-30.1%). Therefore, in clinical practice, transarterial chemoembolization (TACE) or transarterial embolization (TAE) is a preferential and standard treatment of unresectable advanced hepatic carcinoma and has notable advantages in controlling local tumors of the liver. Hepatic arterial infusion of oxaliplatin after TACE can significantly increase the local doses of chemotherapeutic agents in the liver, kill micrometastases and residual foci after embolization and demonstrate outstanding efficacy for treating concomitant portal and hepatic vein tumor thrombi. S-1 is a chemotherapeutic agent with convenient use and definite efficacy and, when used concomitantly with TACE, theoretically can not only effectively control intrahepatic foci but also prevent and control extrahepatic metastatic foci. However, this hasn't been verified in clinical application. This study is intended to investigate efficacy and safety of the combination treatment so as to provide a more effective and safety way for treating patients with advanced hepatic carcinoma (Barcelona stage-C patients with concomitant portal vein tumor thrombi or extrahepatic metastasis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE+HAIC-OXA+S-1 | Experimental | Drug: S-1 |
| TACE+HAIC-OXA | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Signing the informed consent form;
- Diagnosed with HCC
- Patients with hepatic cirrhosis must comply with AASLD (American Association for the Study of Liver Diseases) diagnostic criteria:
- Typical radiological examination (ultrasonography, CT or MRI) manifestations: dynamic enhanced examination shows arterial-phase rapid heterogeneous enhancement and reduced venous-phase or delayed-phase rapid enhancement of space occupation in liver;
- If the diameter of space occupation in liver is ≥2cm, the diagnosis can be established if any of radiological examinations shows the above HCC characteristics;
Key exclusion criteria (36 listed)
- Early or middle-stage primary HCC
- Any contraindication of TACE therapy
- Foci having undergone local treatment (e.g. resection, RFA, PEI or argon-helium cryoablation) cannot be used as the target foci
- Local therapy or systemic chemotherapy within 4 weeks before inclusion or during the study period
- Acute toxic reaction of CTC grade AE2 or above in any local treatment before inclusion
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 |
|---|---|---|
| S-1Begin oral administration of S-1 from the 2nd day after TACE therapy plus arterial indwelling catheter chemotherapy (Oxaliplatin) | Drug | TACE+HAIC-OXA+S-1 |
Primary outcome
Time to progression(TTP)
Time frame: Up to 2 years
Time to clinically definite disease progression
4 secondary outcomes
Overall survival(OS)
Time frame: Up to 2 years
Response rate (RR)
Time frame: Up to 2 years
Disease Control Rate (DCR)
Time frame: Up to 2 years
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: Up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
Zhu Xu, Master principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing S-1 in people with Hepatocellular Carcinoma, run by Zhu Xu 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 27 inclusion and 36 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 28 Nov 2013. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Zhu Xu, Master (0086-10-88196476, zhux387@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression(TTP) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2013.