Recurrent Hepatocellular CancerNCT05162898
Radiofrequency Ablation Combined With Toripalimab and Lenvatinib in the Treatment of Short-term Recurrent Hepatocellular Carcinoma.
A study testing toripalimab, Lenvatinib and Radiofrequency ablation in people with Recurrent Hepatocellular Cancer, run by Henan Cancer Hospital.
Trial summary
This study is a multi-center, prospective, single-arm, open-design phase II clinical study, mainly to explore the clinical effectiveness and safety of radiofrequency ablation combined with anti-PD-1 antibody toripalimab and lenvatinib in patients with short-term recurrence of hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent Hepatocellular Cancer
- What is being tested?
- toripalimab, Lenvatinib and Radiofrequency ablation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Dec 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, ≤75 years old, no gender limit;
- Primary hepatocellular carcinoma confirmed pathologically and clinically;
- After radical resection and 2 months after radiofrequency ablation, no tumor lesions were found in imaging examination (MRI, CT plain scan enhancement), and recurrence and no metastasis of liver cancer occurred within 1 year after surgery;
- ECOG score 0-1 points (Appendix 1);
- Recurrent liver cancer meets Milan criteria: single tumor diameter ≤ 5 cm or multiple tumors less than 3 with maximum diameter ≤ 3 cm, no large vessel infiltration, no lymph node or extrahepatic metastasis;
- Child-Pugh liver function classification: A, B;
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- Expected survival> 6 months;
- Sufficient organ function: ①No growth factor and blood component support is required within 2 weeks before enrollment; ②Heart function: no heart disease or coronary heart disease, the patient's heart function is grade 1-2; ③Within 7 days before enrollment , Has sufficient liver and kidney function, suitable laboratory indicators (untreated): HGB≧9.0g/dl, neutrophils≧1,500/mm3, PLT≧50x109/L, serum ALB≧28g/L, TBIL< 2 mg/dL, ALT, AST<5 times the upper limit of normal value, Bun, Cr<1.5 times the upper limit of normal value, INR<1.7 or prolonged PT<3s;
- Patients with normal blood pressure or hypertension should use antihypertensive drugs to control their blood pressure within the normal range;
- The fasting blood sugar of diabetic patients should be controlled at ≤8mmol/L through hypoglycemic drugs;
- No other serious diseases that conflict with this plan (such as autoimmune diseases, immunodeficiency, organ transplantation);
- No history of other malignant tumors;
- Women of childbearing age must have a negative blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraceptive measures during the test and within 6 months after the test;
- The patient himself agrees to participate in this clinical study and signs the "Informed Consent".
Who cannot join
- Previously received radiotherapy, chemotherapy, hormone therapy or molecular targeted therapy;
- Patients with distant metastasis confirmed by imaging;
- The subject has previously or simultaneously suffered from other malignant tumors (except for cured skin basal cell carcinoma and cervical carcinoma in situ);
- The subjects who have been treated with toripalimab or other PD-1/PD-L1 treatments in the past cannot be included in the group; the subject is known to have been allergic to macromolecular protein preparations, or is known to be allergic to any of the components of teriprizumab;
- The subject has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis , Nephritis, hyperthyroidism, reduced thyroid function; subjects suffering from vitiligo or asthma in childhood has been completely relieved, and can be included in adults without any intervention; subjects requiring bronchodilators for medical intervention can not be included;
- The subject is using immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve immunosuppressive purposes (dose>10mg/day prednisone or other curative hormones), and within 2 weeks before enrollment Still in use;
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- Cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Heart failure above NYHA level 2 (2) Unstable angina (3) Myocardial infarction occurred within 1 year (4) Supraventricular with clinical significance Or patients with ventricular arrhythmia in need of treatment or intervention;
- Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg>2g/L), have bleeding tendency or are receiving thrombolysis or anticoagulation therapy;
- The patient currently (within 3 months) has gastrointestinal diseases such as esophageal varices, active gastric and duodenal ulcers, ulcerative colitis, portal hypertension, or active bleeding from unresected tumors, or the investigator determines Other conditions that may cause gastrointestinal bleeding and perforation;
- Past or current severe bleeding (bleeding >30 ml within 3 months), hemoptysis (>5 ml fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient cerebral deficiencies) within 12 months Blood attack);
- Past and current patients with objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc.;
- Subjects with congenital or acquired immune deficiencies, such as HIV infection, or active hepatitis (transaminase does not meet the selection criteria, hepatitis B reference: HBV DNA ≥10⁴/ml; hepatitis C reference: HCV RNA ≥103/ml); chronic Carriers of hepatitis B virus, HBV DNA <2000 IU/ml (<104 copies/ml), must receive antiviral therapy at the same time during the trial period before they can be included in the group;
- The subject is participating in other clinical studies or is less than one month away from the end of the previous clinical study; the subject may receive other systemic anti-tumor treatments during the study period;
- The subject is known to have a history of psychotropic drug abuse, alcohol abuse or drug abuse;
- Re-examination within 2 months after the operation, the patient with tumor recurrence or metastasis confirmed by imaging examination.
- The investigator believes that it should be excluded from this study. For example, according to the investigator's judgment, the subject has other factors that may cause the study to be terminated halfway, such as other serious diseases (including mental illness) that require combined treatment. Serious laboratory examination abnormalities, accompanied by family or social factors, will affect the safety of subjects, or the collection of data and samples.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University
This study is a multi-center, prospective, single-arm, open-design phase II clinical study, mainly to explore the clinical effectiveness and safety of radiofrequency ablation combined with anti-PD-1 antibody toripalimab and lenvatinib in patients with short-term recurrence of hepatocellular carcinoma.
Read the detailed description
Primary endpoint: Recurrence-free survival time (RFS). Secondary endpoints: safety (incidence of adverse events); time to recurrence (TTR); time to local recurrence (TTLR); 12-month recurrence-free survival rate; overall survival (OS); 12 months and 24 Month overall survival rate.
Treatment plan: Patients undergo radiofrequency ablation, 3-5 days after radiofrequency ablation, lenvatinib 12 mg (body weight ≥ 60 kg) or 8 mg (body weight <60 kg) orally, once a day; toripalimab is a fixed dose of 240 mg, once every 3 weeks, intravenous infusion on the first day of each cycle, the infusion time is no less than 60 minutes.Combination therapy until tumor recurrence, disease progression, death or intolerable toxicity occurs.
- Conditions
- Recurrent Hepatocellular Cancer
- Being tested
- toripalimab, Lenvatinib, Radiofrequency ablation
- Keywords
- PD-1 Inhibitor, Radiofrequency ablation, toripalimab, lenvatinib, Hepatocellular Cancer
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
toripalimabDrug
240mg,ivgtt, every three weeks as a cycle, the first day of each cycle.
LenvatinibDrug
12mg (weight ≥60kg) or 8mg (weight <60kg) orally, once a day
Radiofrequency ablationDevice
ultrasound-guided percutaneous radiofrequency ablation of recurrent hepatocellular carcinoma
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 | Experimental | Not described Receives: Drug: toripalimab; Drug: Lenvatinib; Device: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
RFS
Recurrence-free survival time
Measured: up to 36 months
Secondary outcomes (6)
safety
Adverse event rate
Measured: 24 months
TTR
time to recurrence
Measured: up to 36 months
1-year RFS%
1-year recurrence-free survival rate
Measured: 12 months
OS
overall survival
Measured: 2025
1-year OS%
1-year overall survival rate
Measured: 12 months
2-year OS%
2-year overall survival rate
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study startJan 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Hepatocellular CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162898
- Sponsor's protocol ID
- 2021-245
- Status last verified
- Nov 2021
- First submitted
- 28 Nov 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University
- ClinicalTrials.gov ID
- NCT05162898
- Acronym / sponsor ID
- 2021-245
- Conditions
- Recurrent Hepatocellular Cancer
- Keywords
- PD-1 Inhibitor, Radiofrequency ablation, toripalimab, lenvatinib, Hepatocellular Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- Jan 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Dec 2021 (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 study is a multi-center, prospective, single-arm, open-design phase II clinical study, mainly to explore the clinical effectiveness and safety of radiofrequency ablation combined with anti-PD-1 antibody toripalimab and lenvatinib in patients with short-term recurrence of hepatocellular carcinoma.
Detailed description
Primary endpoint: Recurrence-free survival time (RFS). Secondary endpoints: safety (incidence of adverse events); time to recurrence (TTR); time to local recurrence (TTLR); 12-month recurrence-free survival rate; overall survival (OS); 12 months and 24 Month overall survival rate.
Treatment plan: Patients undergo radiofrequency ablation, 3-5 days after radiofrequency ablation, lenvatinib 12 mg (body weight ≥ 60 kg) or 8 mg (body weight <60 kg) orally, once a day; toripalimab is a fixed dose of 240 mg, once every 3 weeks, intravenous infusion on the first day of each cycle, the infusion time is no less than 60 minutes.Combination therapy until tumor recurrence, disease progression, death or intolerable toxicity occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 | Experimental | Drug: toripalimab, Drug: Lenvatinib, Device: Radiofrequency ablation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥18 years old, ≤75 years old, no gender limit;
- Primary hepatocellular carcinoma confirmed pathologically and clinically;
- After radical resection and 2 months after radiofrequency ablation, no tumor lesions were found in imaging examination (MRI, CT plain scan enhancement), and recurrence and no metastasis of liver cancer occurred within 1 year after surgery;
- ECOG score 0-1 points (Appendix 1);
- Recurrent liver cancer meets Milan criteria: single tumor diameter ≤ 5 cm or multiple tumors less than 3 with maximum diameter ≤ 3 cm, no large vessel infiltration, no lymph node or extrahepatic metastasis;
Key exclusion criteria (16 listed)
- Previously received radiotherapy, chemotherapy, hormone therapy or molecular targeted therapy;
- Patients with distant metastasis confirmed by imaging;
- The subject has previously or simultaneously suffered from other malignant tumors (except for cured skin basal cell carcinoma and cervical carcinoma in situ);
- The subjects who have been treated with toripalimab or other PD-1/PD-L1 treatments in the past cannot be included in the group; the subject is known to have been allergic to macromolecular protein preparations, or is known to be allergic to any of the components of teriprizumab;
- The subject has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis , Nephritis, hyperthyroidism, reduced thyroid function; subjects suffering from vitiligo or asthma in childhood has been completely relieved, and can be included in adults without any intervention; subjects requiring bronchodilators for medical intervention can not be included;
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 |
|---|---|---|
| toripalimab240mg,ivgtt, every three weeks as a cycle, the first day of each cycle. | Drug | GROUP 1 |
| Lenvatinib12mg (weight ≥60kg) or 8mg (weight <60kg) orally, once a day | Drug | GROUP 1 |
| Radiofrequency ablationultrasound-guided percutaneous radiofrequency ablation of recurrent hepatocellular carcinoma | Device | GROUP 1 |
Primary outcome
RFS
Time frame: up to 36 months
Recurrence-free survival time
6 secondary outcomes
safety
Time frame: 24 months
TTR
Time frame: up to 36 months
1-year RFS%
Time frame: 12 months
OS
Time frame: 2025
1-year OS%
Time frame: 12 months
2-year OS%
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing toripalimab, Lenvatinib and Radiofrequency ablation in people with Recurrent Hepatocellular Cancer, run by Henan Cancer Hospital.
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 14 inclusion and 16 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 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Jinxue Zhou, MD (13837175001, zhoujx888@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RFS (time frame: up to 36 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 27 Jan 2022.