Liver, Cancer of, Primary ResectablePhase 3NCT05701436
Applicability of 3D-HDRA in Patients With Primary Liver Cancer: A Randomized Controlled Trial
A Phase 3 study testing Oxaliplatin, Doxorubicin and Lobaplatin in people with Liver, Cancer of, Primary Resectable, run by Zhujiang Hospital at 1 site in China.
Trial summary
This Randomized Controlled Trial was to clarity the clinical feasibility of 3D-HDRA results in guiding the drug use of interventional chemotherapy after primary liver cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver, Cancer of, Primary Resectable
- What is being tested?
- Oxaliplatin, Doxorubicin and Lobaplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 Mar 2026
- 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
- Patients voluntarily cooperated with the study and signed an informed consent form.
- Any gender, age 18 or older, 75 or younger.
- Patients who need to confirm the maximum tumor load (the maximum diameter of a single tumor lesion) before performing radical surgery; patients with a confirmed diagnosis of primary liver cancer after postoperative pathological histological examination.
- Patients with R0 resection confirmed by imaging and pathology (no residual lesions and complete tumor resection after radical surgery).
- Child-Pugh score of 5-7 (A or B), patients with a score of 7 must be free of ascites.
- ECOG physical fitness status score of 0-1.
- Women of childbearing age with a negative pregnancy test and willing to use effective contraception for the duration of the study.
Who cannot join
- Patients with recurrent liver cancer.
- Patients with existing extrahepatic distant metastases (including local lymph node metastases or distant organ metastases: e.g., lung, brain, bone, etc.) at the time of diagnosis.
- Treatment with other experimental drugs or other interventions after radical resection.
- Patients with other malignant tumors that have not been cured within 5 years.
- Patients with non-radical resections (R1 and R2 resections).
- Patients with residual or recurrent lesions detected on imaging within 1-2 months after surgery.
- Patients in whom death occurred within 30 days after surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
Mingxin Pan, Prof, 18928918216, pmxwxy@sohu.com
About this study
Official title: Applicability of 3D Histoculture Drug Response Assay(3D-HDRA) in Patients With Primary Liver Cancer: A Randomized Controlled Trial
This Randomized Controlled Trial was to clarity the clinical feasibility of 3D-HDRA results in guiding the drug use of interventional chemotherapy after primary liver cancer surgery.
Read the detailed description
Data of Patients who received 3D-HDRA after primary liver cancer radical reaction and received Transarterial Chemoembolization #will be collected #excluding incomplete data.
The primary endpoint was the one-year disease-free survival(DFS) rate #Secondary endpoint was the adverse event.
- Conditions
- Liver, Cancer of, Primary Resectable
- Being tested
- Oxaliplatin, Doxorubicin, Lobaplatin, Cisplatin, Oxaliplatin, Leucovorin, fluorouracil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
130 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
DoxorubicinDrug
20 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
LobaplatinDrug
50 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.
CisplatinDrug
50 mg per square body surface area was used for monthly transhepatic arterial infusions.
Oxaliplatin, Leucovorin, fluorouracilDrug
Oxaliplatin(130 mg per square body surface area), Leucovorin(400 mg per square body surface area), and fluorouracil(2800 mg per square body surface area) were used for monthly transhepatic arterial infusions.
Lobaplatin, RaltitrexedDrug
Lobaplatin(50 mg per square body surface area) and Raltitrexed(3 mg per square body surface area) were used for monthly transhepatic arterial infusions.
| Study group | Role | What they receive |
|---|---|---|
| the test group | Experimental | The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on 3D-HDRA results. Precise transarterial chemoembolization at 1-month intervals for 4 months after surgery. Receives: Drug: Oxaliplatin; Drug: Doxorubicin; Drug: Lobaplatin; Drug: Cisplatin; Drug: Oxaliplatin, Leucovorin, fluorouracil; Drug: Lobaplatin, Raltitrexed |
| the control group | Active comparator | The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization. Empirical transarterial chemoembolization at 1-month intervals for 4 months after surgery. Receives: Drug: Oxaliplatin; Drug: Doxorubicin; Drug: Lobaplatin; Drug: Cisplatin; Drug: Oxaliplatin, Leucovorin, fluorouracil; Drug: Lobaplatin, Raltitrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
The one-year DFS rate
The one-year DFS rate is defined as the percentage of participants who have not accrued disease at the time of 1 year
Measured: From the start date of the Treatment until date of the time of 1 year
Secondary outcomes (1)
Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: From the beginning of therapy until the date of death from any cause(max 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 Sep 2022
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver, Cancer of, Primary ResectableStudies of the same condition, open and under way.
- More trials run by Zhujiang 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on 3D-HDRA results, and the control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization.
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mingxin Pan, Prof, Study director, Study Principal Investigator Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701436
- Sponsor's protocol ID
- 2022-KY-277-01
- Status last verified
- Jan 2023
- First submitted
- 18 Jan 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applicability of 3D Histoculture Drug Response Assay(3D-HDRA) in Patients With Primary Liver Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05701436
- Acronym / sponsor ID
- 2022-KY-277-01
- Conditions
- Liver, Cancer of, Primary Resectable
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 27 Jan 2023 (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 Randomized Controlled Trial was to clarity the clinical feasibility of 3D-HDRA results in guiding the drug use of interventional chemotherapy after primary liver cancer surgery.
Detailed description
Data of Patients who received 3D-HDRA after primary liver cancer radical reaction and received Transarterial Chemoembolization #will be collected #excluding incomplete data.
The primary endpoint was the one-year disease-free survival(DFS) rate #Secondary endpoint was the adverse event.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on 3D-HDRA results, and the control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization.
| Arm | Type | Receives |
|---|---|---|
| the test group | Experimental | Drug: Oxaliplatin, Drug: Doxorubicin, Drug: Lobaplatin, Drug: Cisplatin, Drug: Oxaliplatin, Leucovorin, fluorouracil, Drug: Lobaplatin, RaltitrexedThe test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on 3D-HDRA results. Precise transarterial chemoembolization at 1-month intervals for 4 months after surgery. |
| the control group | Active comparator | Drug: Oxaliplatin, Drug: Doxorubicin, Drug: Lobaplatin, Drug: Cisplatin, Drug: Oxaliplatin, Leucovorin, fluorouracil, Drug: Lobaplatin, RaltitrexedThe control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization. Empirical transarterial chemoembolization at 1-month intervals for 4 months after surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients voluntarily cooperated with the study and signed an informed consent form.
- Any gender, age 18 or older, 75 or younger.
- Patients who need to confirm the maximum tumor load (the maximum diameter of a single tumor lesion) before performing radical surgery; patients with a confirmed diagnosis of primary liver cancer after postoperative pathological histological examination.
- Patients with R0 resection confirmed by imaging and pathology (no residual lesions and complete tumor resection after radical surgery).
- Child-Pugh score of 5-7 (A or B), patients with a score of 7 must be free of ascites.
Key exclusion criteria (7 listed)
- Patients with recurrent liver cancer.
- Patients with existing extrahepatic distant metastases (including local lymph node metastases or distant organ metastases: e.g., lung, brain, bone, etc.) at the time of diagnosis.
- Treatment with other experimental drugs or other interventions after radical resection.
- Patients with other malignant tumors that have not been cured within 5 years.
- Patients with non-radical resections (R1 and R2 resections).
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 |
|---|---|---|
| Oxaliplatin130 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month. | Drug | the control group, the test group |
| Doxorubicin20 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month. | Drug | the control group, the test group |
| Lobaplatin50 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month. | Drug | the control group, the test group |
| Cisplatin50 mg per square body surface area was used for monthly transhepatic arterial infusions. | Drug | the control group, the test group |
| Oxaliplatin, Leucovorin, fluorouracilOxaliplatin(130 mg per square body surface area), Leucovorin(400 mg per square body surface area), and fluorouracil(2800 mg per square body surface area) were used for monthly transhepatic arterial infusions. | Drug | the control group, the test group |
| Lobaplatin, RaltitrexedLobaplatin(50 mg per square body surface area) and Raltitrexed(3 mg per square body surface area) were used for monthly transhepatic arterial infusions. | Drug | the control group, the test group |
Primary outcome
The one-year DFS rate
Time frame: From the start date of the Treatment until date of the time of 1 year
The one-year DFS rate is defined as the percentage of participants who have not accrued disease at the time of 1 year
1 secondary outcome
Adverse events
Time frame: From the beginning of therapy until the date of death from any cause(max 24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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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.
Mingxin Pan, Prof study director
Study Principal Investigator Southern Medical University, China
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 Oxaliplatin, Doxorubicin and Lobaplatin in people with Liver, Cancer of, Primary Resectable, run by Zhujiang 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 7 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 2 Mar 2023. 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 Mingxin Pan, Prof (18928918216 ext. 18928918216, pmxwxy@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The one-year DFS rate (time frame: From the start date of the Treatment until date of the time of 1 year). 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 2 Mar 2023.