Hepatocellular Carcinoma ResectablePhase 3NCT05766605
Applicability of PDOX in Patients With Primary Liver Cancer: A Randomized Controlled Trial
A Phase 3 study testing Oxaliplatin, Doxorubicin and Lobaplatin in people with Hepatocellular Carcinoma Resectable, run by Zhujiang Hospital at 1 site in China.
Trial summary
This Randomized Controlled Trial was to clarity the clinical feasibility of PDOX 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
- Hepatocellular Carcinoma 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
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 30 Jan 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
- Undergone radical surgical resection.
- Aged 18-75.
- Patients voluntarily cooperated with the study and signed an informed consent form.
- Histopathologically diagnosed hepatocellular carcinoma.
- 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.
- No serious heart, lung, or renal dysfunction
Who cannot join
- Unable to provide specimens for PDOX testing.
- Patients with recurrent liver cancer.
- Developing two or more types of tumors simultaneously.
- Patients with existing extrahepatic distant metastases.
- Treatment with other experimental drugs or other interventions after radical resection.
- Patients with other malignant tumors that have not been cured within 5 years.
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- Patients with non-radical resections (R1 and R2 resections).
- Patients with residual or recurrent lesions detected on imaging within 1-2 months after surgery.
- Died within 1 month after surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510220
Mingxin Pan, Prof., +8618928918216, pmxwxy@sohu.com
About this study
Official title: Applicability of Patient Derived Orthotopic Xenograft (PDOX) in Patients With Primary Liver Cancer: A Randomized Controlled Trial
This Randomized Controlled Trial was to clarity the clinical feasibility of PDOX results in guiding the drug use of interventional chemotherapy after primary liver cancer surgery.
Read the detailed description
Data of Patients who received PDOX 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
- Hepatocellular Carcinoma 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 PDOX results. Precise transarterial chemoembolization at 1-month intervals for 2 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 with Doxorubicin. Empirical transarterial chemoembolization at 1-month intervals for 2 months after surgery. Receives: Drug: Doxorubicin |
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 posted13 Mar 2023
- Study start1 Jan 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion30 Jan 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 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 PDOX results, and the control group received postoperative conventional treatment combined with empirical transarterial chemoembolization with Doxorubicin.
- Masking
- None (open label)
- Enrolment
- 90 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
- NCT05766605
- Sponsor's protocol ID
- 2022-KY-298-01
- Status last verified
- Feb 2023
- First submitted
- 1 Mar 2023
- Last updated
- 13 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 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applicability of Patient Derived Orthotopic Xenograft (PDOX) in Patients With Primary Liver Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05766605
- Acronym / sponsor ID
- 2022-KY-298-01
- Conditions
- Hepatocellular Carcinoma Resectable
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 13 Mar 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 PDOX results in guiding the drug use of interventional chemotherapy after primary liver cancer surgery.
Detailed description
Data of Patients who received PDOX 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 PDOX results, and the control group received postoperative conventional treatment combined with empirical transarterial chemoembolization with Doxorubicin.
| 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 PDOX results. Precise transarterial chemoembolization at 1-month intervals for 2 months after surgery. |
| the control group | Active comparator | Drug: DoxorubicinThe control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization with Doxorubicin. Empirical transarterial chemoembolization at 1-month intervals for 2 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 (8 listed)
- Undergone radical surgical resection.
- Aged 18-75.
- Patients voluntarily cooperated with the study and signed an informed consent form.
- Histopathologically diagnosed hepatocellular carcinoma.
- Patients with R0 resection confirmed by imaging and pathology (no residual lesions and complete tumor resection after radical surgery).
Key exclusion criteria (9 listed)
- Unable to provide specimens for PDOX testing.
- Patients with recurrent liver cancer.
- Developing two or more types of tumors simultaneously.
- Patients with existing extrahepatic distant metastases.
- Treatment with other experimental drugs or other interventions after radical resection.
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 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 test group |
| Cisplatin50 mg per square body surface area was used for monthly transhepatic arterial infusions. | Drug | 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 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 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 13 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 Hepatocellular Carcinoma 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 8 inclusion and 9 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 13 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. (+8618928918216, 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 13 Mar 2023.