Hepatocellular Carcinoma Non-resectableTIKETNCT06487663
TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors
A study testing TACE with ICI in people with Hepatocellular Carcinoma Non-resectable and Cholangiocarcinoma Non-resectable, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study will evaluate the efficacy and safety of TACE combined with immune checkpoint inhibitors to treat unresectable hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma Non-resectable, Cholangiocarcinoma Non-resectable, Liver Metastases
- What is being tested?
- TACE with ICI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2020to 27 Oct 2026
- Phase
- Interventional
- 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
- Confirmed diagnosis of HCC by histology/ cytology or clinical criteria
- Sign informed consent
- When screening for age, the age should be ≥ 18 years old
- Eligible for TACE treatment
- ECOG physical condition score is 0 or 1
- No prior systemic therapy for HCC, especially immunotherapy
- According to the following mRECIST criteria, at least one measurable intrahepatic lesion is suitable for repeated evaluation
Who cannot join
- Have any history of kidney disease or nephrotic syndrome
- Evidence of extrahepatic spread (EHS)
- Cardiovascular diseases with clinical significance (such as activity), including unstable angina, ≥ grade 2 congestive heart failure, and arrhythmia with poor drug treatment control
- Any condition representing a contraindication to TACE as determined by the investigators
- Known genetic factors for bleeding or thrombosis; Any previous or current evidence indicating a tendency for bleeding
- Individuals who have received immunotherapy (anti PD-1, anti PD-L1, or anti CTLA-4 treatment)
- Previously received HAIC (hepatic artery infusion chemotherapy), TACE (hepatic artery chemoembolization), TAE (hepatic artery embolization), or TARE (hepatic artery radiation embolization)
- Previously received systemic anti-cancer treatment for HCC ,ICC or liver metastasis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Yu Zheng, 0086-22-23340123, info@tjmuch.com
Haipeng Yu, PhD
About this study
Official title: Transcatheter Hepatic Artery Chemoembolization Combined With Immune Checkpoint Inhibitors for Liver Tumors
This study will evaluate the efficacy and safety of TACE combined with immune checkpoint inhibitors to treat unresectable hepatocellular carcinoma.
Read the detailed description
The specific operation of TACE is based on the CSCO Diagnosis and Treatment Guidelines for Primary Liver Cancer (2022 Edition). TACE is performed through microcatheters. After TACE, the coaxial catheter is retained in the hepatic artery or left or right hepatic artery branch. The specific body plan is oxaliplatin+calcium folinate+5-Fu (FOLFOX) (J Hepatol, 2018). Oxaliplatin 85mg/m2 was continuously injected through arterial pump for more than 4 hours on the first day. After HAIC is completed, remove the catheter and sheath. Repeat catheterization in the next treatment cycle.
Immune checkpoint inhibitors can be administered arterial starting after the first TACE treatment, q4w (± 3 days). If the situation requires, the arterial administration of ICI can be adjusted forward or backward for 7 days to adapt to TACE treatment.
- Conditions
- Hepatocellular Carcinoma Non-resectable, Cholangiocarcinoma Non-resectable, Liver Metastases, Liver Malignant Tumors
- Being tested
- TACE with ICI
- Keywords
- Hepatocellular Carcinoma, Cholangiocarcinoma, Liver Metastases, Liver Malignant Tumors
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE with ICIProcedure or surgery
Transcatheter hepatic artery chemoembolization and immune checkpoint inhibitors
| Study group | Role | What they receive |
|---|---|---|
| TACE combined ICI | Experimental | TACE combined ICI Receives: Procedure: TACE with ICI |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival
Measured: 3 years
OS
Overall Survival
Measured: 3 years
Secondary outcomes (1)
ORR
Objective response rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start27 Oct 2020
- Primary completion27 Oct 2025 (estimated)
- Study completion27 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-resectableStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haipeng Yu, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487663
- Sponsor's protocol ID
- TCHIO-001
- Acronym
- TIKET
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Hepatic Artery Chemoembolization Combined With Immune Checkpoint Inhibitors for Liver Tumors
- ClinicalTrials.gov ID
- NCT06487663
- Acronym / sponsor ID
- TIKET / TCHIO-001
- Conditions
- Hepatocellular Carcinoma Non-resectable, Cholangiocarcinoma Non-resectable, Liver Metastases, Liver Malignant Tumors
- Keywords
- Hepatocellular Carcinoma, Cholangiocarcinoma, Liver Metastases, Liver Malignant Tumors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 27 Oct 2025 (estimated)
- Study completion
- 27 Oct 2026 (estimated)
- First posted
- 5 Jul 2024 (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 study will evaluate the efficacy and safety of TACE combined with immune checkpoint inhibitors to treat unresectable hepatocellular carcinoma.
Detailed description
The specific operation of TACE is based on the CSCO Diagnosis and Treatment Guidelines for Primary Liver Cancer (2022 Edition). TACE is performed through microcatheters. After TACE, the coaxial catheter is retained in the hepatic artery or left or right hepatic artery branch. The specific body plan is oxaliplatin+calcium folinate+5-Fu (FOLFOX) (J Hepatol, 2018). Oxaliplatin 85mg/m2 was continuously injected through arterial pump for more than 4 hours on the first day. After HAIC is completed, remove the catheter and sheath. Repeat catheterization in the next treatment cycle.
Immune checkpoint inhibitors can be administered arterial starting after the first TACE treatment, q4w (± 3 days). If the situation requires, the arterial administration of ICI can be adjusted forward or backward for 7 days to adapt to TACE treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE combined ICI | Experimental | Procedure: TACE with ICITACE combined ICI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed diagnosis of HCC by histology/ cytology or clinical criteria
- Sign informed consent
- When screening for age, the age should be ≥ 18 years old
- Eligible for TACE treatment
- ECOG physical condition score is 0 or 1
Key exclusion criteria (8 listed)
- Have any history of kidney disease or nephrotic syndrome
- Evidence of extrahepatic spread (EHS)
- Cardiovascular diseases with clinical significance (such as activity), including unstable angina, ≥ grade 2 congestive heart failure, and arrhythmia with poor drug treatment control
- Any condition representing a contraindication to TACE as determined by the investigators
- Known genetic factors for bleeding or thrombosis; Any previous or current evidence indicating a tendency for bleeding
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 |
|---|---|---|
| TACE with ICITranscatheter hepatic artery chemoembolization and immune checkpoint inhibitors | Procedure or surgery | TACE combined ICI |
Primary outcome
PFS
Time frame: 3 years
Progression free survival
OS
Time frame: 3 years
Overall Survival
1 secondary outcome
ORR
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TACE with ICI in people with Hepatocellular Carcinoma Non-resectable and Cholangiocarcinoma Non-resectable, run by Tianjin Medical University Cancer Institute and Hospital 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 7 inclusion and 8 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 5 Jul 2024. 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.
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 Haipeng Yu (022-23340123 ext. 2701, jieruke@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 3 years). The study lists 2 primary outcomes in all. 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 5 Jul 2024.