Hepatic CancerPATOCNCT04764409
Prevention and Treatment of Complications of Endovascular Methods in Patients With Malignant Liver Tumors
An observational study of Hepatic Cancer and Metastatic Cancer, run by Central Clinical Hospital RZD-Medicine, Russian Federation at 1 site in Russia.
Trial summary
In the structure of malignant liver lesions, two main groups are distinguished - primary liver cancer and metastatic liver damage. The five-year survival rate of patients with malignant liver tumors does not exceed 6%. The main and radical method of treatment today is liver resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Cancer, Metastatic Cancer, Chemotherapy Effect
- What is being tested?
- Chemoembolization and Chemoinfusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteRussia
- Study dates
- 12 Jan 2021to 12 Dec 2023
- Phase
- Observational
- 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
Study population: The study is planned to include patients with primary liver cancer and metastatic liver disease, after chemoembolization or chemoinfusion of the hepatic artery.
Who may be able to join
- Aged over 18 years old;
- Histologically confirmed diagnosis of liver cancer or metastatic liver disease;
- Patients who have not received systemic antitumor therapy within the last 6 months
Who cannot join
- Metachronous (within 3 years) or synchronous other oncological disease with the exception of healed carcinoma in situ;
- The volume of liver damage according to computed tomography is more than 60%;
- Increase in the level of transaminases by more than 2 times;
- The level of bilirubin is more than 50 μmol / l;
- Heart failure stage II B-III, Functional Class III-IV;
- The presence of uncorrected coagulopathy;
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- Renal failure stage III-IV;
- Ascites 2-3 degrees;
- The general condition of the patient is below 60% on the Karnofsky index and above 2 points on the Eastern Cooperative Oncology Group (ECOG) scale;
- Liver damage - more than 7 points on the Child-Pugh scale;
- Damage to the central nervous system;
- Anemia of severe severity;
- Pregnancy;
- Active autoimmune disease;
- Presence of HIV infection, active forms of tuberculosis;
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Central Clinical Hospital RZD-Medicine, Russian Federation
Moscow, Moscow's Oblast, 129128
Oksana Stukalova, postgraduate, +79852138906, docstukalova@mail.ru
Roman Ishenko, Professor, +79260878506, ishenkorv@rambler.ru
About this study
In the structure of malignant liver lesions, two main groups are distinguished - primary liver cancer and metastatic liver damage. The five-year survival rate of patients with malignant liver tumors does not exceed 6%. The main and radical method of treatment today is liver resection. However, surgical treatment is possible only in 10-25% of patients. At the same time, recurrence of malignant tumors is observed in 60-80% of cases within five years after surgery, and the number of candidates for repeated liver resection does not exceed 10%. The high toxicity of systemic chemotherapy limits its use in this group of patients. In this connection, minimally invasive and at the same time effective methods of local treatment of malignant liver tumors have been introduced into clinical practice. These methods include: hepatic artery chemoinfusion, chemoembolization and oil chemoembolization.
Currently, a large world experience has already been accumulated in the application of the above methods of treatment. However, any, even minimally invasive, surgical manipulation can be associated with the development of complications of varying severity. If complications arise, there is a risk of interruption of palliative care, which entails a significant reduction in life expectancy. According to domestic and foreign literature, the occurrence of complications after intra-arterial chemoembolization occurs in 0.4-10% of patients, and after intra-arterial chemoinfusion - in 5-30% of patients. In the overwhelming majority of scientific works, the description of the complications that have arisen is reduced to listing the latter. Currently, in the Russian and foreign scientific literature there is no systematization of complications, there is no single clinical classification, algorithms for the prevention and treatment of complications arising after local intravascular methods of treatment of patients with malignant liver tumors.
The study and systematization of complications arising after intra-arterial chemoembolization and chemoinfusion of the hepatic artery in patients with malignant liver tumors will make it possible to create prevention and treatment algorithms. Thus, it will help prevent interruption of palliative care and increase the life expectancy of this cohort of patients.
- Conditions
- Hepatic Cancer, Metastatic Cancer, Chemotherapy Effect
- Being tested
- Chemoembolization, Chemoinfusion
- Keywords
- Chemoembolization
- Medical subject headings
- Liver Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemoembolizationProcedure or surgery
Transarterial Chemoembolization (TACE)
ChemoinfusionProcedure or surgery
Transarterial Infusion (TAI)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | This group includes patients who underwent chemoembolization of hepatic arteria Receives: Procedure: Chemoembolization | |
| Group 2 | This group includes patients who underwent chemoinfusion of hepatic arteria Receives: Procedure: Chemoinfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of all the kinds of complications according to the Common Terminology Criteria for Adverse Events (CTCAE v4.0) and their systematization.
This systematization will lead to the creation of algorithms of prevention and treatment of complications of endovascular methods in patients with malignant liver tumors. For the assessment of the severity of complications there will be created a new scale.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start12 Jan 2021
- Primary completion12 Dec 2022 (estimated)
- Study completion12 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Clinical Hospital RZD-Medicine, Russian Federation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stukalova Oksana Yuryevna, Central Clinical Hospital RZD-Medicine, Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764409
- Sponsor's protocol ID
- CCHRZD00001
- Acronym
- PATOC
- Status last verified
- Feb 2021
- First submitted
- 12 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Treatment of Complications of Endovascular Methods in Patients With Malignant Liver Tumors
- ClinicalTrials.gov ID
- NCT04764409
- Acronym / sponsor ID
- PATOC / CCHRZD00001
- Conditions
- Hepatic Cancer, Metastatic Cancer, Chemotherapy Effect
- Keywords
- Chemoembolization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Central Clinical Hospital RZD-Medicine, Russian FederationUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 12 Dec 2022 (estimated)
- Study completion
- 12 Dec 2023 (estimated)
- First posted
- 21 Feb 2021 (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.
In the structure of malignant liver lesions, two main groups are distinguished - primary liver cancer and metastatic liver damage. The five-year survival rate of patients with malignant liver tumors does not exceed 6%. The main and radical method of treatment today is liver resection. However, surgical treatment is possible only in 10-25% of patients. At the same time, recurrence of malignant tumors is observed in 60-80% of cases within five years after surgery, and the number of candidates for repeated liver resection does not exceed 10%. The high toxicity of systemic chemotherapy limits its use in this group of patients. In this connection, minimally invasive and at the same time effective methods of local treatment of malignant liver tumors have been introduced into clinical practice. These methods include: hepatic artery chemoinfusion, chemoembolization and oil chemoembolization.
Currently, a large world experience has already been accumulated in the application of the above methods of treatment. However, any, even minimally invasive, surgical manipulation can be associated with the development of complications of varying severity. If complications arise, there is a risk of interruption of palliative care, which entails a significant reduction in life expectancy. According to domestic and foreign literature, the occurrence of complications after intra-arterial chemoembolization occurs in 0.4-10% of patients, and after intra-arterial chemoinfusion - in 5-30% of patients. In the overwhelming majority of scientific works, the description of the complications that have arisen is reduced to listing the latter. Currently, in the Russian and foreign scientific literature there is no systematization of complications, there is no single clinical classification, algorithms for the prevention and treatment of complications arising after local intravascular methods of treatment of patients with malignant liver tumors.
The study and systematization of complications arising after intra-arterial chemoembolization and chemoinfusion of the hepatic artery in patients with malignant liver tumors will make it possible to create prevention and treatment algorithms. Thus, it will help prevent interruption of palliative care and increase the life expectancy of this cohort of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: ChemoembolizationThis group includes patients who underwent chemoembolization of hepatic arteria |
| Group 2 | – | Procedure: ChemoinfusionThis group includes patients who underwent chemoinfusion of hepatic arteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study is planned to include patients with primary liver cancer and metastatic liver disease, after chemoembolization or chemoinfusion of the hepatic artery.
Key inclusion criteria (3 listed)
- Aged over 18 years old;
- Histologically confirmed diagnosis of liver cancer or metastatic liver disease;
- Patients who have not received systemic antitumor therapy within the last 6 months
Key exclusion criteria (15 listed)
- Metachronous (within 3 years) or synchronous other oncological disease with the exception of healed carcinoma in situ;
- The volume of liver damage according to computed tomography is more than 60%;
- Increase in the level of transaminases by more than 2 times;
- The level of bilirubin is more than 50 μmol / l;
- Heart failure stage II B-III, Functional Class III-IV;
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 |
|---|---|---|
| ChemoembolizationTransarterial Chemoembolization (TACE) | Procedure or surgery | Group 1 |
| ChemoinfusionTransarterial Infusion (TAI) | Procedure or surgery | Group 2 |
Primary outcome
Identification of all the kinds of complications according to the Common Terminology Criteria for Adverse Events (CTCAE v4.0) and their systematization.
Time frame: 2 years
This systematization will lead to the creation of algorithms of prevention and treatment of complications of endovascular methods in patients with malignant liver tumors. For the assessment of the severity of complications there will be created a new scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Cancer and Metastatic Cancer, run by Central Clinical Hospital RZD-Medicine, Russian Federation at 1 site in Russia.
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 3 inclusion and 15 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 21 Feb 2021. 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 Russia. 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.
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 Oksana Stukalova, Postgraduate (+79852138906, docstukalova@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of all the kinds of complications according to the Common Terminology Criteria for Adverse Events (CTCAE v4.0) and their systematization. (time frame: 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 21 Feb 2021.