Hepatocellular CarcinomaNCT05307926
Postoperative Adjuvant Therapy of HCC Based on PD-1
An observational study of Hepatocellular Carcinoma and RFS, run by Chen Xiaoping at 1 site in China.
Trial summary
For the treatment of hepatocellular carcinoma, liver resection is still one of the optimal options, but the recurrence rate is as high as 70% five years after the operation, and the prognosis of patients with high-risk recurrence factors such as portal vein tumor thrombus and microvascular invasion is even worse, so… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, RFS
- What is being tested?
- PD-1 inhibitors and TACE
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 573 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2019to 20 Aug 2022
- Phase
- Observational
- 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
Study population: Patients had HCC and underwent radical liver resection (R0), postoperative pathology confirmed that they were associated with high-risk factors for recurrence. Depending on the type of recurrence factor, they were treated with appropriate postoperative adjuvant therapy. Patients who received PD-1-based adjuvant therapy or TACE adjuvant therapy were included in this prospective cohort study.
Who may be able to join
- 1. In patients with HCC who received R0 resection, there was no bile duct invasion, extrahepatic invasion, and distant metastasis of lung, bone, and brain
- 2. Patients with high-risk factors for tumor recurrence (tumor diameter ≥ 5cm, multiple tumors, tumor rupture, AFP ≥ 400 ng/dl, microvascular invasion, portal vein thrombosis, and poorly differentiated) and received PD-1-based adjuvant therapy or TACE adjuvant therapy after the surgery
- 3. Aged18-75
- 4. Eastern Cooperative Oncology Group (ECOG) performing status of 0-1
- 5. Child-Pugh grade A or B
- 6. The patient knows, and informed consent was obtained
Who cannot join
- 1. Any history of other malignant tumors or recurrent HCC
- 2. Any preoperative treatment for HCC including local and systemic therapy
- 3. Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
- 4. Any persistent serious surgery-related complications
- 5. Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months
- 6. Inability or refusal to comply with the treatment and monitoring
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: PD-1-based Adjuvant Therapy in High-risk Hepatocellular Carcinoma Patients After Curative Resection
For the treatment of hepatocellular carcinoma, liver resection is still one of the optimal options, but the recurrence rate is as high as 70% five years after the operation, and the prognosis of patients with high-risk recurrence factors such as portal vein tumor thrombus and microvascular invasion is even worse, so it is particularly urgent to find effective postoperative adjuvant treatment. The role of PD-1 inhibitors in preventing the postoperative recurrence of HCC requires further study.
Read the detailed description
We conducted a prospective cohort study comparing the efficacy of PD-1-based adjuvant therapy and transarterial chemoembolization in patients with high-risk factors for recurrence undergoing radical surgery. After surgery, patients received the appropriate adjuvant therapy according to the type of high-risk recurrence factor. Patients with high-risk factors for recurrence who received PD-1-based adjuvant therapy were included in the exposure cohort; patients with high-risk factors for recurrence who received 1 TACE adjuvant therapy were included in the control cohort. The primary endpoint of this study was disease-free survival, and the overall survival and adverse events were considered as the second endpoint.
- Conditions
- Hepatocellular Carcinoma, RFS
- Being tested
- PD-1 inhibitors, TACE
- Keywords
- PD-1, Disease-free survival rate, adjuvant therapy, Lenvatinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 inhibitorsDrug
Also called Lenvatinib
For patients with PVTT, they received adjuvant therapy of PD1 (200mg intravenously every 3 weeks for a total of 18cycles) plus Lenvatinib (8mg orally once a day for 1 year) 2-4 weeks after surgery; for patients with other high-risk factors for recurrence, they PD-1(200mg intravenously every 3 weeks for a total of 9cycles) monotherapy 2-4 weeks after surgery.
TACEProcedure or surgery
Patients with high-risk factors for recurrence received 1 TACE about a month after surgery.
| Study group | Role | What they receive |
|---|---|---|
| PD-1 based therapy cohort | Patients who received PD-1 inhibitors or PD-1 inhibitors plus Lenvatinib therapy 2-4 weeks after the operation were included in the PD-1-based therapy cohort. Receives: Drug: PD-1 inhibitors | |
| TACE cohort | Patients who received 1 TACE about a month after the operation were included in the control cohort. Receives: Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
The primary outcomes of this study include disease-free survival
Measured: From date of inclued in this research until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months
Secondary outcomes (2)
Overall Survival
The secondary outcomes of this study include overall survival
Measured: From date of inclued in this research until the date of death from any cause, assessed up to 60 months.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The primary outcomes of this study include the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start1 Feb 2019
- Primary completion30 Jul 2022
- Study completion20 Aug 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 573 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chen Xiaoping
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Xiaoping, Tongji Hospital
- Investigators
- xiaoping Dr Chen, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307926
- Sponsor's protocol ID
- Y-D202001-0289
- Status last verified
- Sep 2022
- First submitted
- 22 Mar 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-1-based Adjuvant Therapy in High-risk Hepatocellular Carcinoma Patients After Curative Resection
- ClinicalTrials.gov ID
- NCT05307926
- Acronym / sponsor ID
- Y-D202001-0289
- Conditions
- Hepatocellular Carcinoma, RFS
- Keywords
- PD-1, Disease-free survival rate, adjuvant therapy, Lenvatinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 573 participants (actual)
- Lead sponsor
- Chen XiaopingUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 1 Apr 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.
For the treatment of hepatocellular carcinoma, liver resection is still one of the optimal options, but the recurrence rate is as high as 70% five years after the operation, and the prognosis of patients with high-risk recurrence factors such as portal vein tumor thrombus and microvascular invasion is even worse, so it is particularly urgent to find effective postoperative adjuvant treatment. The role of PD-1 inhibitors in preventing the postoperative recurrence of HCC requires further study.
Detailed description
We conducted a prospective cohort study comparing the efficacy of PD-1-based adjuvant therapy and transarterial chemoembolization in patients with high-risk factors for recurrence undergoing radical surgery. After surgery, patients received the appropriate adjuvant therapy according to the type of high-risk recurrence factor. Patients with high-risk factors for recurrence who received PD-1-based adjuvant therapy were included in the exposure cohort; patients with high-risk factors for recurrence who received 1 TACE adjuvant therapy were included in the control cohort. The primary endpoint of this study was disease-free survival, and the overall survival and adverse events were considered as the second endpoint.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD-1 based therapy cohort | – | Drug: PD-1 inhibitorsPatients who received PD-1 inhibitors or PD-1 inhibitors plus Lenvatinib therapy 2-4 weeks after the operation were included in the PD-1-based therapy cohort. |
| TACE cohort | – | Procedure: TACEPatients who received 1 TACE about a month after the operation were included in the control cohort. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients had HCC and underwent radical liver resection (R0), postoperative pathology confirmed that they were associated with high-risk factors for recurrence. Depending on the type of recurrence factor, they were treated with appropriate postoperative adjuvant therapy. Patients who received PD-1-based adjuvant therapy or TACE adjuvant therapy were included in this prospective cohort study.
Key inclusion criteria (6 listed)
- 1. In patients with HCC who received R0 resection, there was no bile duct invasion, extrahepatic invasion, and distant metastasis of lung, bone, and brain
- 2. Patients with high-risk factors for tumor recurrence (tumor diameter ≥ 5cm, multiple tumors, tumor rupture, AFP ≥ 400 ng/dl, microvascular invasion, portal vein thrombosis, and poorly differentiated) and received PD-1-based adjuvant therapy or TACE adjuvant therapy after the surgery
- 3. Aged18-75
- 4. Eastern Cooperative Oncology Group (ECOG) performing status of 0-1
- 5. Child-Pugh grade A or B
Key exclusion criteria (6 listed)
- 1. Any history of other malignant tumors or recurrent HCC
- 2. Any preoperative treatment for HCC including local and systemic therapy
- 3. Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
- 4. Any persistent serious surgery-related complications
- 5. Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months
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 inhibitorsAlso: LenvatinibFor patients with PVTT, they received adjuvant therapy of PD1 (200mg intravenously every 3 weeks for a total of 18cycles) plus Lenvatinib (8mg orally once a day for 1 year) 2-4 weeks after surgery; for patients with other high-risk factors for recurrence, they PD-1(200mg intravenously every 3 weeks for a total of 9cycles) monotherapy 2-4 weeks after surgery. | Drug | PD-1 based therapy cohort |
| TACEPatients with high-risk factors for recurrence received 1 TACE about a month after surgery. | Procedure or surgery | TACE cohort |
Primary outcome
Disease-free survival
Time frame: From date of inclued in this research until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months
The primary outcomes of this study include disease-free survival
2 secondary outcomes
Overall Survival
Time frame: From date of inclued in this research until the date of death from any cause, assessed up to 60 months.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 12months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
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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.
xiaoping Dr Chen study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and RFS, run by Chen Xiaoping 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 6 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: finished, as of the sponsor's last update on 7 Sep 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disease-free survival (time frame: From date of inclued in this research until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months). 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 7 Sep 2022.