Hepatocellular CarcinomaPhase 2/3NCT04025437
Neoadjuvant Radiotherapy for HCC Involving Type I PVTT
A Phase 2/3 study testing Hepatectomy alone and Neoadjuvant radiotherapy in people with Hepatocellular Carcinoma, run by Guangxi Medical University at 1 site in China.
Trial summary
The rate of patients with hepatocellular carcinoma (HCC) involving portal vein tumor thrombus (PVTT) is up to 50% in Guangxi province, China. Some of them will receive hepatic resection, especially those with type I or II PVTT. However, 5-years recurrence rate is up to 75% after surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Hepatectomy alone and Neoadjuvant radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 31 Dec 2021
- Phase
- Phase 2/3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-75 years;
- Patients with resectable primary hepatocellular carcinoma and Cheng's type I portal vein tumor thrombus;
- Child-Pugh A or B (7 score) liver function;
- With more than 3 months expected survival;
- The volume of residual liver more than 30%;
- Patients agree to take part in.
Who cannot join
- Patients with primary hepatocellular carcinoma and Cheng's type II/III/IV portal vein tumor thrombus
- Previous history of epigastric radiotherapy
- With extrahepatic metastasis
- With radiotherapy contraindication;
- Pregnant woman or sucking period;
- With repture tumor;
- With other cancer in previous five years;
- With chemothrapy, target therapy or immunosuppressive drugs therapy.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University
Nanning, Guangxi, 530021
About this study
Official title: Neoadjuvant Radiotherapy for Patients With Hepatocellular Carcinoma Involving Type I Portal Vein Tumor Thrombus
The rate of patients with hepatocellular carcinoma (HCC) involving portal vein tumor thrombus (PVTT) is up to 50% in Guangxi province, China. Some of them will receive hepatic resection, especially those with type I or II PVTT. However, 5-years recurrence rate is up to 75% after surgery. Some retrospective studies found postoperative radiotherapy may reduce the rate of recurrence. Moreover, few retrospective studies also found neoadjuvant radiotherapy (PMID: 27317960) may improve overall survival for HCC patients involving type II/III PVTT. However, the safety and efficacy of neoadjuvant raidotherapy for HCC involving type I PVTT is unknown.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Hepatectomy alone, Neoadjuvant radiotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatectomy aloneProcedure or surgery
Patients in this group will receive hepatectomy alone.
Neoadjuvant radiotherapyRadiation
Radiotherapy for type I PVTT will be perfomed before hepatectomy. Hepatic resection will be performed in about 4 weeks after radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Hepatectomy alone | Experimental | Patients in this group will receive hepatectomy alone. Receives: Procedure: Hepatectomy alone |
| Neoadjuvant radiotherapy plus hepatectomy | Active comparator | Radiotherapy for type I PVTT will be perfomed before hepatectomy. Hepatic resection will be performed in about 4 weeks after radiotherapy. Receives: Radiation: Neoadjuvant radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
From the date of hepatectomy or neoadjuvant radiotherapy to death or the end of follow-up.
Measured: 1 year
Secondary outcomes (1)
Recurrence-free survival
From the date of hepatectomy to HCC recurrence or the end of follow-up.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start1 Mar 2019
- Primary completion30 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Neoadjuvant Radiotherapy
- Masking
- None (open label)
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Hong Zhong, Guangxi Medical University
- Investigators
- Wei-Zhong Tang, MD, Study director, Cancer Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025437
- Sponsor's protocol ID
- RT-HCC-PVTT
- Status last verified
- Sep 2019
- First submitted
- 17 Jul 2019
- Last updated
- 4 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yoon SM, Ryoo BY, Lee SJ, Kim JH, Shin JH, An JH, Lee HC, Lim YS. Efficacy and Safety of Transarterial Chemoembolization Plus External Beam Radiotherapy vs Sorafenib in Hepatocellular Carcinoma With Macroscopic Vascular Invasion: A Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):661-669. doi: 10.1001/jamaoncol.2017.5847.
PubMed 29543938He M, Li Q, Zou R, Shen J, Fang W, Tan G, Zhou Y, Wu X, Xu L, Wei W, Le Y, Zhou Z, Zhao M, Guo Y, Guo R, Chen M, Shi M. Sorafenib Plus Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin vs Sorafenib Alone for Hepatocellular Carcinoma With Portal Vein Invasion: A Randomized Clinical Trial. JAMA Oncol. 2019 Jul 1;5(7):953-960. doi: 10.1001/jamaoncol.2019.0250.
PubMed 31070690Kudo M, Ueshima K, Yokosuka O, Ogasawara S, Obi S, Izumi N, Aikata H, Nagano H, Hatano E, Sasaki Y, Hino K, Kumada T, Yamamoto K, Imai Y, Iwadou S, Ogawa C, Okusaka T, Kanai F, Akazawa K, Yoshimura KI, Johnson P, Arai Y; SILIUS study group. Sorafenib plus low-dose cisplatin and fluorouracil hepatic arterial infusion chemotherapy versus sorafenib alone in patients with advanced hepatocellular carcinoma (SILIUS): a randomised, open label, phase 3 trial. Lancet Gastroenterol Hepatol. 2018 Jun;3(6):424-432. doi: 10.1016/S2468-1253(18)30078-5. Epub 2018 Apr 7.
PubMed 29631810Li N, Feng S, Xue J, Wei XB, Shi J, Guo WX, Lau WY, Wu MC, Cheng SQ, Meng Y. Hepatocellular carcinoma with main portal vein tumor thrombus: a comparative study comparing hepatectomy with or without neoadjuvant radiotherapy. HPB (Oxford). 2016 Jun;18(6):549-56. doi: 10.1016/j.hpb.2016.04.003. Epub 2016 May 7.
PubMed 27317960
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Radiotherapy for Patients With Hepatocellular Carcinoma Involving Type I Portal Vein Tumor Thrombus
- ClinicalTrials.gov ID
- NCT04025437
- Acronym / sponsor ID
- RT-HCC-PVTT
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 Jul 2019 (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.
The rate of patients with hepatocellular carcinoma (HCC) involving portal vein tumor thrombus (PVTT) is up to 50% in Guangxi province, China. Some of them will receive hepatic resection, especially those with type I or II PVTT. However, 5-years recurrence rate is up to 75% after surgery. Some retrospective studies found postoperative radiotherapy may reduce the rate of recurrence. Moreover, few retrospective studies also found neoadjuvant radiotherapy (PMID: 27317960) may improve overall survival for HCC patients involving type II/III PVTT. However, the safety and efficacy of neoadjuvant raidotherapy for HCC involving type I PVTT is unknown.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Neoadjuvant Radiotherapy
| Arm | Type | Receives |
|---|---|---|
| Hepatectomy alone | Experimental | Procedure: Hepatectomy alonePatients in this group will receive hepatectomy alone. |
| Neoadjuvant radiotherapy plus hepatectomy | Active comparator | Radiation: Neoadjuvant radiotherapyRadiotherapy for type I PVTT will be perfomed before hepatectomy. Hepatic resection will be performed in about 4 weeks after radiotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-75 years;
- Patients with resectable primary hepatocellular carcinoma and Cheng's type I portal vein tumor thrombus;
- Child-Pugh A or B (7 score) liver function;
- With more than 3 months expected survival;
- The volume of residual liver more than 30%;
Key exclusion criteria (8 listed)
- Patients with primary hepatocellular carcinoma and Cheng's type II/III/IV portal vein tumor thrombus
- Previous history of epigastric radiotherapy
- With extrahepatic metastasis
- With radiotherapy contraindication;
- Pregnant woman or sucking period;
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 |
|---|---|---|
| Hepatectomy alonePatients in this group will receive hepatectomy alone. | Procedure or surgery | Hepatectomy alone |
| Neoadjuvant radiotherapyRadiotherapy for type I PVTT will be perfomed before hepatectomy. Hepatic resection will be performed in about 4 weeks after radiotherapy. | Radiation | Neoadjuvant radiotherapy plus hepatectomy |
Primary outcome
Overall survival
Time frame: 1 year
From the date of hepatectomy or neoadjuvant radiotherapy to death or the end of follow-up.
1 secondary outcome
Recurrence-free survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
- Background: PubMed 29543938Yoon SM, Ryoo BY, Lee SJ, Kim JH, Shin JH, An JH, Lee HC, Lim YS. Efficacy and Safety of Transarterial Chemoembolization Plus External Beam Radiotherapy vs Sorafenib in Hepatocellular Carcinoma With Macroscopic Vascular Invasion: A Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):661-669. doi: 10.1001/jamaoncol.2017.5847.
- Background: PubMed 31070690He M, Li Q, Zou R, Shen J, Fang W, Tan G, Zhou Y, Wu X, Xu L, Wei W, Le Y, Zhou Z, Zhao M, Guo Y, Guo R, Chen M, Shi M. Sorafenib Plus Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin vs Sorafenib Alone for Hepatocellular Carcinoma With Portal Vein Invasion: A Randomized Clinical Trial. JAMA Oncol. 2019 Jul 1;5(7):953-960. doi: 10.1001/jamaoncol.2019.0250.
- Background: PubMed 29631810Kudo M, Ueshima K, Yokosuka O, Ogasawara S, Obi S, Izumi N, Aikata H, Nagano H, Hatano E, Sasaki Y, Hino K, Kumada T, Yamamoto K, Imai Y, Iwadou S, Ogawa C, Okusaka T, Kanai F, Akazawa K, Yoshimura KI, Johnson P, Arai Y; SILIUS study group. Sorafenib plus low-dose cisplatin and fluorouracil hepatic arterial infusion chemotherapy versus sorafenib alone in patients with advanced hepatocellular carcinoma (SILIUS): a randomised, open label, phase 3 trial. Lancet Gastroenterol Hepatol. 2018 Jun;3(6):424-432. doi: 10.1016/S2468-1253(18)30078-5. Epub 2018 Apr 7.
- Background: PubMed 27317960Li N, Feng S, Xue J, Wei XB, Shi J, Guo WX, Lau WY, Wu MC, Cheng SQ, Meng Y. Hepatocellular carcinoma with main portal vein tumor thrombus: a comparative study comparing hepatectomy with or without neoadjuvant radiotherapy. HPB (Oxford). 2016 Jun;18(6):549-56. doi: 10.1016/j.hpb.2016.04.003. Epub 2016 May 7.
- 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.
Wei-Zhong Tang, MD study director
Cancer Hospital of Guangxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Hepatectomy alone and Neoadjuvant radiotherapy in people with Hepatocellular Carcinoma, run by Guangxi Medical University 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 6 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 4 Sep 2019. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04025437, which also lists 4 linked publications.
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 4 Sep 2019.