Hepatocellular CarcinomaPhase 3NCT05472896
TACE With Dicycloplatin(TP21) in Unresectable HCC
A Phase 3 study testing cTACE, Dicycloplatin (TP21) and Epirubicin in people with Hepatocellular Carcinoma, run by Gao-jun Teng at 1 site in China.
Trial summary
To evaluate the effectiveness and safety of TP21 injection for TACE in treatment of hepatocellular carcinoma: 1. Primary efficacy endpoint: progression-free survival (PFS), which will be assessed by the Independent Review Committee according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST). 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- cTACE, Dicycloplatin (TP21) and Epirubicin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2022to 30 Jun 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or older, and life expectancy ≥ 3 months;
- histopathologically or clinically confirmed HCC;
- Child-Pugh class A or B liver function (≤7 level), Eastern Cooperative Oncology Group performance status (PS) score of 0, 1 or 2；
- China Liver Cancer stage IIb, IIIa (only Cheng's classification type I:portal vein tumor thrombus invading the portal vein branches of the liver lobe or liver segment) , and Ib, 2a patients who can be surgically removed, but are unable or unwilling to undergo surgery due to other reasons (such as advanced age, severe liver cirrhosis, etc.);
- at least one lesion measurable by modified Response Evaluation Criteria in Solid Tumors for HCC (mRECIST);
- no history of TACE or tumor recurrence after curative-intent therapy (i.e., surgical resection or ablation);
- No blood transfusion and blood products, no use of granulocyte colony-stimulating factor (GCSF) and other hematopoietic stimulating factors within 2 weeks before screening; Hemoglobin ≥ 80g/L；Platelet count ≥ 60×10^9 /L; White blood cell count ≥ 3×10^9/L; Alanine aminotransferase ≤ 3 times the upper limit of normal; Aspartate aminotransferase ≤ 3×times the upper limit of normal; Serum creatinine Cr ≤ 1.5×times the upper limit of normal;
Who cannot join
- allergic to platinum or iodine products or epirubicin and related excipients;
- diffuse HCC (whole liver tumor burden ≥ 70%),and the hepatocellular carcinoma is hypovascular;
- first-order branches and distant of the portal vein tumor thrombus;
- Liver function classification is Child Pugh C;
- Invasion of left and right hepatic duct, common hepatic duct, cystic duct and common bile duct;
- The tumor has severe arteriovenous shunt, which the investigator judges may affect the efficacy of TACE; or there is extrahepatic metastasis;
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- Patients with other tumors, except for thyroid tumors and skin carcinoma in situ that have been cured, early cervical cancer;
- Have a history of gastrointestinal bleeding or a marked tendency to gastrointestinal bleeding within 6 months before randomization;
- Uncorrectable abnormal coagulation function or bleeding tendency;
- received other antitumor therapies within the past 4 weeks (e.g., chemotherapy, radiotherapy, immunotherapy,Chinese medicine with antitumor effect), or received the above anti-tumor drugs within 5 half-lives;
- received immunotherapy, targeted therapy or radiotherapy for intrahepatic tumors
- have received an organ transplant
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009
Hai-Dong Zhu, 86-25-83262224, zhuhaidong9509@163.com
About this study
Official title: TACE With Dicycloplatin（TP21） in Patients With Unresectable Hepatocellular Carcinoma: an Open, Parallel-controlled,Multicenter Randomized Phase III Trial
To evaluate the effectiveness and safety of TP21 injection for TACE in treatment of hepatocellular carcinoma:
- Primary efficacy endpoint: progression-free survival (PFS), which will be assessed by the Independent Review Committee according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST).
- Secondary efficacy endpoints: PFS, objective response rate (ORR), disease control rate (DCR), overall survival (OS), time to progression (TTP), 1-year progression-free survival, 1-year survival and 2-year survival assessed by the investigator.
Read the detailed description
TP21 injection is a supramolecular compound that has completed early pharmacological and toxicological preclinical studies, as well as phase I and II clinical studies. Data from previous studies showed that TP21 injection has significant advantages over traditional platinum-based drugs in terms of broad spectrum, low toxicity, high efficacy and low drug resistance etc. The results of the Phase II TACE clinical exploratory study in hepatocellular carcinoma showed a trend for TP21 alone to be significantly better than epirubicin alone, and due to the small sample size, the available data were insufficient to demonstrate obvious advantage of this drug. Now, a confirmatory phase III clinical study of TACE for hepatocellular carcinoma is needed, which may continue to adopt the main design of the phase II clinical trial, in a single agent comparison form: all the subjects will be randomized 1:1 into TP21+lipiodol group (trial group), and epirubicin hydrochloride+lipiodol group (control group) to receive TACE treatment of either "TP21+lipiodol" or "epirubicin hydrochloride+lipiodol". TACE treatment should be carried out for no more than 3 times in half a year to no more than 5 times within 1 year, and about 332 subjects will be enrolled, 166 for the trial group and the control group each.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- cTACE, Dicycloplatin (TP21), Epirubicin
- Keywords
- Hepatocellular Carcinoma, TACE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cTACEProcedure or surgery
transcatheter arterial chemoembolization with
Dicycloplatin (TP21)Drug
the dosage of dicycloplatin was based on the body surface area (550 mg/m2) according to previous research. The volume ratio of lipiodol to dicycloplatin aqueous solution was 1:1. The volume of lipiodol used was calculated by the size and vascularity of the tumor, within 20 mL.
EpirubicinDrug
the dosage of epirubicin was determined according to the tumor size, and the maximum dose was limited to 40 mg. The volume ratio of lipiodol to epirubicin aqueous solution was 2:1. The volume of lipiodol used was calculated by the size and vascularity of the tumor, within 20 mL.
| Study group | Role | What they receive |
|---|---|---|
| cTACE with TP21 | Experimental | In experimental groups, the dosage of dicycloplatin (TP21) was based on the body surface area (550 mg/m2) according to previous research. If grade III or above myelosuppression was observed, an adjusted dose of 450 mg/m2 was then considered, or the patient was removed from the group at the investigator's discretion.The volume ratio of lipiodol to dicycloplatin aqueous solution was 1:1.The volume of lipiodol used was calculated by the size and vascularity of the tumor, within 20 mL. Standardized gelatin sponge particles of 150-350 μm or 350-560 μm in diameter were injected following embolization with ethiodized oil-chemoembolic emulsion. Receives: Procedure: cTACE; Drug: Dicycloplatin (TP21) |
| cTACE with epirubicin | Active comparator | the dosage of epirubicin was determined according to the tumor size, and the maximum dose was limited to 40 mg. The volume ratio of lipiodol to epirubicin aqueous solution was 2:1. The volume of lipiodol used was calculated by the size and vascularity of the tumor, within 20 mL. Standardized gelatin sponge particles of 150-350 μm or 350-560 μm in diameter were injected following embolization with ethiodized oil-chemoembolic emulsion. Receives: Procedure: cTACE; Drug: Epirubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) by Independent Review Committee
Progression-free survival (PFS) by Independent Review Committee (IRC) according to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST).
Measured: Up to ~1 years
Secondary outcomes (8)
Progression-free survival (PFS) by investigator
Progression-free survival (PFS) by investigator according to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST).
Measured: Up to ~1 years
Objective Response Rate (ORR)
Measured: Up to ~1 years
Disease Control Rate (DCR)
Measured: Up to ~1 years
Overall Survival (OS)
Measured: Up to ~3 years
Time To Progress (TTP)
Measured: Up to ~3 years
1 year progression-free survival rate
Measured: Up to ~1 years
1 year survival rate
Measured: Up to ~1 years
2 year survival rate
Measured: Up to ~2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start9 Jun 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- an open, parallel-controlled, multicenter randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gao-jun Teng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-Jun Teng, Doctor, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472896
- Sponsor's protocol ID
- TP21-TACE
- Status last verified
- Jul 2022
- First submitted
- 22 Jul 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- 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 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TACE With Dicycloplatin（TP21） in Patients With Unresectable Hepatocellular Carcinoma: an Open, Parallel-controlled,Multicenter Randomized Phase III Trial
- ClinicalTrials.gov ID
- NCT05472896
- Acronym / sponsor ID
- TP21-TACE
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, TACE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Gao-jun TengUniversity, hospital or other
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 25 Jul 2022 (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.
To evaluate the effectiveness and safety of TP21 injection for TACE in treatment of hepatocellular carcinoma:
- Primary efficacy endpoint: progression-free survival (PFS), which will be assessed by the Independent Review Committee according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST).
- Secondary efficacy endpoints: PFS, objective response rate (ORR), disease control rate (DCR), overall survival (OS), time to progression (TTP), 1-year progression-free survival, 1-year survival and 2-year survival assessed by the investigator.
Detailed description
TP21 injection is a supramolecular compound that has completed early pharmacological and toxicological preclinical studies, as well as phase I and II clinical studies. Data from previous studies showed that TP21 injection has significant advantages over traditional platinum-based drugs in terms of broad spectrum, low toxicity, high efficacy and low drug resistance etc. The results of the Phase II TACE clinical exploratory study in hepatocellular carcinoma showed a trend for TP21 alone to be significantly better than epirubicin alone, and due to the small sample size, the available data were insufficient to demonstrate obvious advantage of this drug. Now, a confirmatory phase III clinical study of TACE for hepatocellular carcinoma is needed, which may continue to adopt the main design of the phase II clinical trial, in a single agent comparison form: all the subjects will be randomized 1:1 into TP21+lipiodol group (trial group), and epirubicin hydrochloride+lipiodol group (control group) to receive TACE treatment of either "TP21+lipiodol" or "epirubicin hydrochloride+lipiodol". TACE treatment should be carried out for no more than 3 times in half a year to no more than 5 times within 1 year, and about 332 subjects will be enrolled, 166 for the trial group and the control group each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- an open, parallel-controlled, multicenter randomized trial
| Arm | Type | Receives |
|---|---|---|
| cTACE with TP21 | Experimental | Procedure: cTACE, Drug: Dicycloplatin (TP21)In experimental groups, the dosage of dicycloplatin (TP21) was based on the body surface area (550 mg/m2) according to previous research. If grade III or above myelosuppression was observed, an adjusted dose of 450 mg/m2 was then considered, or the patient was removed from the group at the investigator's discretion.The volume ratio of lipiodol to dicycloplatin aqueous solution was 1:1.The volume of lipiodol used was calculated by the size and vascularity of the tumor, within 20 mL. Standardized gelatin sponge particles of 150-350 μm or 350-560 μm in diameter were injected following embolization with ethiodized oil-chemoembolic emulsion. |
| cTACE with epirubicin | Active comparator | Procedure: cTACE, Drug: Epirubicinthe dosage of epirubicin was determined according to the tumor size, and the maximum dose was limited to 40 mg. The volume ratio of lipiodol to epirubicin aqueous solution was 2:1. The volume of lipiodol used was calculated by the size and vascularity of the tumor, within 20 mL. Standardized gelatin sponge particles of 150-350 μm or 350-560 μm in diameter were injected following embolization with ethiodized oil-chemoembolic emulsion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 18 years or older, and life expectancy ≥ 3 months;
- histopathologically or clinically confirmed HCC;
- Child-Pugh class A or B liver function (≤7 level), Eastern Cooperative Oncology Group performance status (PS) score of 0, 1 or 2；
- China Liver Cancer stage IIb, IIIa (only Cheng's classification type I:portal vein tumor thrombus invading the portal vein branches of the liver lobe or liver segment) , and Ib, 2a patients who can be surgically removed, but are unable or unwilling to undergo surgery due to other reasons (such as advanced age, severe liver cirrhosis, etc.);
- at least one lesion measurable by modified Response Evaluation Criteria in Solid Tumors for HCC (mRECIST);
Key exclusion criteria (12 listed)
- allergic to platinum or iodine products or epirubicin and related excipients;
- diffuse HCC (whole liver tumor burden ≥ 70%),and the hepatocellular carcinoma is hypovascular;
- first-order branches and distant of the portal vein tumor thrombus;
- Liver function classification is Child Pugh C;
- Invasion of left and right hepatic duct, common hepatic duct, cystic duct and common bile duct;
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 |
|---|---|---|
| cTACEtranscatheter arterial chemoembolization with | Procedure or surgery | cTACE with TP21, cTACE with epirubicin |
| Dicycloplatin (TP21)the dosage of dicycloplatin was based on the body surface area (550 mg/m2) according to previous research. The volume ratio of lipiodol to dicycloplatin aqueous solution was 1:1. The volume of lipiodol used was calculated by the size and vascularity of the tumor, within 20 mL. | Drug | cTACE with TP21 |
| Epirubicinthe dosage of epirubicin was determined according to the tumor size, and the maximum dose was limited to 40 mg. The volume ratio of lipiodol to epirubicin aqueous solution was 2:1. The volume of lipiodol used was calculated by the size and vascularity of the tumor, within 20 mL. | Drug | cTACE with epirubicin |
Primary outcome
Progression-free survival (PFS) by Independent Review Committee
Time frame: Up to ~1 years
Progression-free survival (PFS) by Independent Review Committee (IRC) according to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST).
8 secondary outcomes
Progression-free survival (PFS) by investigator
Time frame: Up to ~1 years
Objective Response Rate (ORR)
Time frame: Up to ~1 years
Disease Control Rate (DCR)
Time frame: Up to ~1 years
Overall Survival (OS)
Time frame: Up to ~3 years
Time To Progress (TTP)
Time frame: Up to ~3 years
1 year progression-free survival rate
Time frame: Up to ~1 years
1 year survival rate
Time frame: Up to ~1 years
2 year survival rate
Time frame: Up to ~2years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- 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.
Gao-Jun Teng, Doctor principal investigator
Zhongda Hospital
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 cTACE, Dicycloplatin (TP21) and Epirubicin in people with Hepatocellular Carcinoma, run by Gao-jun Teng 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 12 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 25 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hai-Dong Zhu Doctor, Doctor (13851420979, zhuhaidong9509@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) by Independent Review Committee (time frame: Up to ~1 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 25 Jul 2022.