Hepatocellular CarcinomaNCT03914352
A Novel Immunotherapy PD-1 Antiboty to Suppress Recurrence of HCC Combined With PVTT After Hepatic Resection
A study testing PD-1 antibody and TACE in people with Hepatocellular Carcinoma, run by Cancer Hospital of Guangxi Medical University at 1 site in China.
Trial summary
Hepatic resection is the most effective curative treatment for resectable HCC, whereas frequent recurrence usually impaired the efficacy of hepatic resection and contributed poor survivals. PVTT has been certified as an independent risk of early recurrence. 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?
- PD-1 antibody and TACE
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 31 Jan 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HCC comfirmed by postoperative histology examination
- PVTT comfirmed by postoperative histology examination
- None other type of malignant tumors
- None intra or extra-hepatic recurrence postoperative adjuvant therapy
- Child-pugh grade A or B liver function
- None other organ dysfunction
Who cannot join
- Combined with other type of malignant tumors
- Presence of intra or extra-hepatic recurrence
- Child-pugh grade C liver function
- Combined with other organ dysfunction
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Jiazhou Ye, M.D., +86 13367719078, 87066160@qq.com
Lequn Li, M.D., +86 07715310045, lequn_li001@163.com
About this study
Official title: A Novel Immunotherapy PD-1 Antiboty to Suppress Recurrence of Hepatocellular Carcinoma Combined With Portal Vein Thrombus After Hepatic Resection
Hepatic resection is the most effective curative treatment for resectable HCC, whereas frequent recurrence usually impaired the efficacy of hepatic resection and contributed poor survivals. PVTT has been certified as an independent risk of early recurrence.
Although TACE has been used to decrease the intraheptic recurrence. However, the intraheptic recurrence rate remains high and meanwhile it is uncapable to suppress extrahepatic recurrence. In addition, systematic therapy the small molecular target antiangiogenesis medicine sorafenib were used to prevent recurrence. Unfortunately, the STORM trial shows that postoperative antiangiogenesis therapy was failed to suppress recurrence and prolong survival period for HCC patients. Thus, novel effective systematic therapy to suppress postoperative recurrence is in urgent need.
At present, the PD-1 antibody has presented a promising and safe therapeutic result of unresectable HCC and provided good survival benefit for advanced HCC patients. Consistent with this, we proposed a hypothesis that a novel immunetherapy using the PD-1 antibody could suppress postoperative recurrence and prolong HCC patients survival period effectively.
Read the detailed description
Hepatic resection is the most effective curative treatment for resectable hepatocellular carcinoma (HCC), whereas frequent recurrence usually impaired the efficacy of hepatic resection and contributed poor survivals. Portal vein tumor thrombus (PVTT) has been certified as an independent risk of early recurrence (≤2years after hepatic resection).
Although Transarterial Chemoembolization (TACE) has been used as an effective local adjuvant treatment to decrease the intraheptic recurrence. However, the intraheptic recurrence rate remains high and meanwhile it is uncapable to suppress extrahepatic recurrence. In addition, systematic therapy the small molecular target antiangiogenesis medicine sorafenib were used to prevent recurrence. Unfortunately, the double blind randomized STORM trial shows a negative result that postoperative antiangiogenesis therapy was failed to suppress recurrence and prolong survival period for HCC patients. Thus, novel effective systematic therapy to suppress postoperative recurrence is in urgent need.
At present, the PD-1 antibody has presented a promising and safe therapeutic result of unresectable HCC and provided good survival benefit for advanced HCC patients. Consistent with this, we proposed a hypothesis that a novel immunetherapy using the PD-1 antibody could suppress postoperative recurrence and prolong HCC patients survival period effectively.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- PD-1 antibody, TACE
- Keywords
- Hepatocellular carcinoma, Portal vein tumor thrombus, Hepatic resection, Recurrence, PD-1 antibody
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 antibodyDrug
Also called SHR-1210
In this group participants were treated with PD-1 antibody (240mg, Intravenous drip infusion, Q14 days) since the15 days after hepatic resection and at the interval of 15 days.
TACEProcedure or surgery
In this group enrolled patients were treated with TACE at the30 days after hepatic resection.
| Study group | Role | What they receive |
|---|---|---|
| PD-1 antibody group | Experimental | In this group participants were treated with PD-1 antibody (240mg, Intravenous drip infusion, Q14 days) since the15 days after hepatic resection and at the interval of 15 days. Receives: Drug: PD-1 antibody |
| Controlled group | Active comparator | In this group entrolled patients were treated with TACE in the 30 days after hepatic resection. Receives: Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Cumulative survival period after hepatic resection
Measured: 5 years
Disease-free survival
Cumulative none recurrence survival period after hepatic resection
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Apr 2019
- Primary completion30 Dec 2019 (estimated)
- Study completion31 Jan 2020 (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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia-zhou Ye, Cancer Hospital of Guangxi Medical University
- Investigators
- Lequn Li, M.D., Study chair, Cancer Hospital of Guangxi Medical UniversityJiazhou Ye, M.D., Principal investigator, Cancer Hospital of Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914352
- Sponsor's protocol ID
- CHGuangxiMU
- Status last verified
- Apr 2019
- First submitted
- 10 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Immunotherapy PD-1 Antiboty to Suppress Recurrence of Hepatocellular Carcinoma Combined With Portal Vein Thrombus After Hepatic Resection
- ClinicalTrials.gov ID
- NCT03914352
- Acronym / sponsor ID
- CHGuangxiMU
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Portal vein tumor thrombus, Hepatic resection, Recurrence, PD-1 antibody
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cancer Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 16 Apr 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.
Hepatic resection is the most effective curative treatment for resectable HCC, whereas frequent recurrence usually impaired the efficacy of hepatic resection and contributed poor survivals. PVTT has been certified as an independent risk of early recurrence.
Although TACE has been used to decrease the intraheptic recurrence. However, the intraheptic recurrence rate remains high and meanwhile it is uncapable to suppress extrahepatic recurrence. In addition, systematic therapy the small molecular target antiangiogenesis medicine sorafenib were used to prevent recurrence. Unfortunately, the STORM trial shows that postoperative antiangiogenesis therapy was failed to suppress recurrence and prolong survival period for HCC patients. Thus, novel effective systematic therapy to suppress postoperative recurrence is in urgent need.
At present, the PD-1 antibody has presented a promising and safe therapeutic result of unresectable HCC and provided good survival benefit for advanced HCC patients. Consistent with this, we proposed a hypothesis that a novel immunetherapy using the PD-1 antibody could suppress postoperative recurrence and prolong HCC patients survival period effectively.
Detailed description
Hepatic resection is the most effective curative treatment for resectable hepatocellular carcinoma (HCC), whereas frequent recurrence usually impaired the efficacy of hepatic resection and contributed poor survivals. Portal vein tumor thrombus (PVTT) has been certified as an independent risk of early recurrence (≤2years after hepatic resection).
Although Transarterial Chemoembolization (TACE) has been used as an effective local adjuvant treatment to decrease the intraheptic recurrence. However, the intraheptic recurrence rate remains high and meanwhile it is uncapable to suppress extrahepatic recurrence. In addition, systematic therapy the small molecular target antiangiogenesis medicine sorafenib were used to prevent recurrence. Unfortunately, the double blind randomized STORM trial shows a negative result that postoperative antiangiogenesis therapy was failed to suppress recurrence and prolong survival period for HCC patients. Thus, novel effective systematic therapy to suppress postoperative recurrence is in urgent need.
At present, the PD-1 antibody has presented a promising and safe therapeutic result of unresectable HCC and provided good survival benefit for advanced HCC patients. Consistent with this, we proposed a hypothesis that a novel immunetherapy using the PD-1 antibody could suppress postoperative recurrence and prolong HCC patients survival period effectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD-1 antibody group | Experimental | Drug: PD-1 antibodyIn this group participants were treated with PD-1 antibody (240mg, Intravenous drip infusion, Q14 days) since the15 days after hepatic resection and at the interval of 15 days. |
| Controlled group | Active comparator | Procedure: TACEIn this group entrolled patients were treated with TACE in the 30 days after hepatic resection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HCC comfirmed by postoperative histology examination
- PVTT comfirmed by postoperative histology examination
- None other type of malignant tumors
- None intra or extra-hepatic recurrence postoperative adjuvant therapy
- Child-pugh grade A or B liver function
Key exclusion criteria (4 listed)
- Combined with other type of malignant tumors
- Presence of intra or extra-hepatic recurrence
- Child-pugh grade C liver function
- Combined with other organ dysfunction
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 |
|---|---|---|
| PD-1 antibodyAlso: SHR-1210In this group participants were treated with PD-1 antibody (240mg, Intravenous drip infusion, Q14 days) since the15 days after hepatic resection and at the interval of 15 days. | Drug | PD-1 antibody group |
| TACEIn this group enrolled patients were treated with TACE at the30 days after hepatic resection. | Procedure or surgery | Controlled group |
Primary outcome
Overall survival
Time frame: 5 years
Cumulative survival period after hepatic resection
Disease-free survival
Time frame: 5 years
Cumulative none recurrence survival period after hepatic resection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- 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.
Lequn Li, M.D. study chair
Cancer Hospital of Guangxi Medical University
Jiazhou Ye, M.D. principal investigator
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 study testing PD-1 antibody and TACE in people with Hepatocellular Carcinoma, run by Cancer Hospital of 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 4 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 16 Apr 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.
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 Jiazhou Ye, M.D. (+86 13367719078, 87066160@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 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 16 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.