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Hepatocellular CarcinomaPhase 1/2NCT04652440

Ablation Combined With PD-1 in HCC: Phase II Study

A Phase 1/2 study testing PD-1 monoclonal antibody and Radiofequencey or microwave ablation in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a Phase 2, single arm, single center study designed to evaluate the safety and tolerability of radiofrequency or microwave ablation combined with PD-1 monoclonal antibody in patients with hepatocellular carcinoma(HCC), with the secondary study objective to preliminarily evaluate the efficacy of radiofrequency… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
PD-1 monoclonal antibody and Radiofequencey or microwave ablation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
15 Dec 2020to 30 Jun 2024
Phase
Phase 1/2
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

  • Patients who voluntarily participate in the study and sign the informed consent form
  • 18 ~ 75 years old, both men and women
  • Clinical diagnosis of hepatocellular carcinoma, conforming to the indications of radiofrequency or microwave ablation
  • Child-Pugh score ≤6 (Child-Pugh score A)
  • Barcelona Clinic Liver Cancer (BCLC) Stage A or B
  • Number of tumors ≤ 2; 2 cm<maximum diameter≤ 5 cm
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  • No distant metastasis or lymph node metastasis (defined as lymph node maximum transverse diameter ≥ 15 mm)
  • ECOG score 0 or 1
  • No history of drug allergy;
  • The function of vital organs meets the following requirements (no blood component, cell growth factor and other corrective treatment drugs are allowed to be used 14 days before enrollment) 1）Absolute neutrophil count≥1.5×109/L; 2）Platelets≥80×109/L; 3）Hemoglobin≥90 g/L; 4）Serum albumin≥30 g/L; 5）Thyroid stimulating hormone (TSH) ≤1×ULN (if abnormal, FT3 and FT4 should also be investigated, and patients whose FT3 and FT4 levels are normal can be enrolled); 6) Bilirubin≤1.5×ULN (within 7 days prior to the first dose); 7) ALT and AST≤3×ULN (within 7 days prior to the first dose); 8) No prolongation of PT by more than 3 seconds above the ULN; 9)Serum creatinine≤1.5×ULN;
  • Female patients who are not surgically sterilized or of reproductive age need to use contraceptive measures (such as intrauterine device, contraceptives or condoms) during the study treatment period and within 3 months after the end of the study treatment period; female patients of childbearing potential who are not surgically sterilized must have a negative serum or urine HCG test within 72 hours before enrollment; and must be non-lactating; male patients with partners of childbearing potential should take an effective method of contraception during the trial and within 3 months after treatment.

Who cannot join

  • Patients unsuitable for percutaneous radiofrequency or microwave ablation for any reason
  • 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; vitiligo; patients with complete remission of asthma in childhood but requiring no intervention after adulthood can be included; patients with asthma requiring medical intervention with bronchodilators can not be included)
  • Patients who need to use immunosuppressive agents or require systemic hormone therapy to achieve the purpose of immunosuppression (dose > 10 mg/day prednisone or other effective hormones) and are still using them within 2 weeks before enrollment
  • Prior systemic anticancer therapy
  • Received or intended to receive other anticancer therapy (vascular intervention, etc.) other than surgical resection or ablative therapy
  • Known history of central nervous system metastasis or hepatic encephalopathy
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  • Tumor necrosis cannot be confirmed by reexamination of imaging after local ablation
  • Clinically symptomatic ascites requiring puncture and drainage or those who have received ascites drainage in the past 3 months, except those with only a small amount of ascites shown by imaging but not accompanied by clinical symptoms
  • Hypertension not well controlled by antihypertensive medication (systolic blood pressure≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg)
  • Uncontrolled cardiac clinical symptoms or diseases, such as: (1) heart failure above NYHA2; (2) unstable angina; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; (5)QTc > 450 ms (male); QTc > 470 ms (female)
  • Abnormal coagulation function (INR > 2.0, PT > 16s), bleeding tendency or receiving thrombolytic or anticoagulant therapy. Prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed
  • Patients with clinically significant bleeding symptoms or bleeding tendency within 3 months before randomization, such as hemoptysis more than 2.5ml per day, gastrointestinal bleeding, esophageal and gastric varices at risk of bleeding, hemorrhagic gastric ulcer, vasculitis, etc. If the stool occult blood is positive at baseline, reexamination must be performed. if it is still positive after reexamination, gastroscopy is required. If gastroscopy suggests severe esophageal and gastric varices, patients can't be enrolled (except for those who receive gastroscopy to rule out such conditions within 3 months before enrollment)
  • Arterial/venous thrombotic events occurred within 6 months before enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism
  • Known hereditary or acquired bleeding and thrombophilia (such as hemophilia, coagulation dysfunction, thrombocytopenia, etc.)
  • Urine routine test showed urine protein≥+ + and 24-hour urine protein > 1.0 g is confirmed
  • Patients who previously received radiotherapy, chemotherapy and hormone therapy for anti-cancer
  • Patients with active infection or fever of unknown origin 7 days before the first dose, T≥38℃, or baseline white blood cell count > 15×109/L
  • Patients with congenital or acquired immunodeficiency (such as HIV infection)
  • Untreated active hepatitis virus infection with HBV DNA > 2000 IU/m (l or 104 copies/ml), HCV RNA > 103 copies/ml
  • Patients with other malignant tumors (except cured cutaneous basal cell carcinoma and carcinoma in situ of cervix) within 3 years previously or simultaneously
  • Patients who have other factors that may affect the study results or cause the study to be halted, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, severe laboratory abnormalities, with family or social factors that may affect the safety and compliance of patients as judged by the investigator

Trial locations and contacts

1 site in 1 country.

Min-Shan Chen, Ph.D. contact

+86-20-87343115

chenmsh@sysucc.org.cn

Li Xu contact

xuli@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    minshan chen, M.D., 8620-87343117 ext. 8620-87343117, chminsh@mail.sysu.edu.cn

    yaojun zhang, M.D., 8620-87343121, zhyaojun@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Phase II Study of Ablation Combined With PD-1 Antibody in Patients With Hepatocellular Carcinoma

This is a Phase 2, single arm, single center study designed to evaluate the safety and tolerability of radiofrequency or microwave ablation combined with PD-1 monoclonal antibody in patients with hepatocellular carcinoma(HCC), with the secondary study objective to preliminarily evaluate the efficacy of radiofrequency or microwave ablation combined with PD-1 monoclonal antibody in patients with HCC and the exploratory study objective to evaluate the effect of ablation combined with PD-1 monoclonal antibody on immune function and hepatitis virus infection status in patients with HCC. This study will be divided into two stages, and the first stage is to enroll 6 patients for dose-limited toxicity (DLT) observation. If DLT appeared in < 2 patients, the second stage was entered and the other 24 patients were further enrolled.

Read the detailed description

The enrolled patients received intravenous injection of PD-1 monoclonal antibody (tirelizumab 200mg) on the day before ablation and the 21 (± 7) days, the 42 (+ 7) days and the 63 (+ 7) days after ablation, respectively (a total of 4 times). Liver tumor biopsy was performed during ablation, tissue samples will be stored for pathological examination and test of PD-L1 expression.

Liver enhanced MRI or CT and contrast-enhanced ultrasound were reviewed within 4 ~ 6 weeks after the first ablation treatment to evaluate the complete response rate of the tumor after treatment. Patients suspected of local incomplete ablation in either of the two examinations could receive a salvage ablation for once within 12 weeks of the first ablation, but no extra dose of PD-1 antibody would be given. Patients with residual viable tumor after re-ablation were defined as treatment failure.

The first six patients (stage I) underwent detailed physical examination on the 2nd, 7th, 14th and 21st days after receiving the first dose of study drug, and 30 days after the 2nd and 4th doses of study drugs. Blood tests and urine routine were performed on the 2nd day after treatment, as well as ECG examination. In the second stage, the patients underwent examinations on the second and 21st days after the dose of study drug, and on the 30 days after the last dose of study drug (the above examination can be carried out within ± 7 days). If there are clinically significant study related adverse events (including abnormal test results) in patients in stage I, necessary reexamination and visit would be added in patients in stage II.

Radiological evaluation arrangement: liver enhanced MRI or CT and contrast-enhanced ultrasound were performed within 4 ~ 6 weeks after the first ablation. The second imaging examination would be completed within 4 ~ 6 weeks after the end of the study treatment, and then examined according to the following schedule: CT / MRI was repeated every 3 months within the first year, then every 4 months within the next year, and every 6 months after 2 years. The investigators will evaluate the adverse events during the follow-up. After the patients have radiologically confirmed recurrence and/or metastasis, they will be treated according to the guideline without limitation. The information of all anti-cancer treatments they received need to be collected.

Follow-up by phone will be conducted at least every 6 months until death to find out the patient's survival data, as well as their physical condition and information about other anticancer treatment received.

Being tested
PD-1 monoclonal antibody, Radiofequencey or microwave ablation
Keywords
Radiofrequency ablation, PD-1 Inhibitor, Hepatocellular Carcinoma, Microwave ablation
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 monoclonal antibodyDrug

    Also called Tislelizumab

    The enrolled patients received intravenous injections of PD-1 monoclonal antibody (Tislelizumab 200mg) on the 1 day before radiofrequency or microwave ablation treatment, and 21(±7) days, 42(+7) and 63(+7) after ablation.

  • Radiofequencey or microwave ablationProcedure or surgery

    Also called ablation

    The enrolled patients received primary radiofrequency or microwave ablation on the day after the first dose of PD-1 antibody treatment.

Study groups in NCT04652440
Study groupRoleWhat they receive
Radiofrequency or microwave ablation combined with PD-1 monoclonal antibodyExperimentalPatients who meet the inclusion criteria will receive 1 cycle of PD-1 antibody on the day before ablation, then 3 cycles of PD-1 antibody after primary radiofrequency or microwave ablation, on a schedule of per 3 weeks, then be followed until disease relapse or death.
Receives: Drug: PD-1 monoclonal antibody; Procedure: Radiofequencey or microwave ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measure Safety

    Treatment-related adverse events (TRAEs) and serious adverse events (SAEs) occurring from the start of PD-1 monoclonal antibody therapy to 90 days after treatment were observed and judged according to CTCAE 5.0 criteria.

    Measured: from the start of PD-1 monoclonal antibody therapy to 90 days after treatment

  2. Measure Tolerability

    Measured as the rate of patients able to complete treatment as planned in the study.

    Measured: from the start of PD-1 monoclonal antibody therapy to 90 days after treatment

Secondary outcomes (5)

  1. Complete Response (CR1)

    Complete response rate of single ablation combined with PD-1 monoclonal antibody in patients with hepatocellular carcinoma

    Measured: Two years

  2. Treatment Failure Rate (TFR)

    Rate of treatment failure (rate of patients with lesions residue after first ablation and tumor survival after re-ablation)

    Measured: Two years

  3. Local Recurrence Rate (LRR) and Distant Metastasis Rate (DMR)

    1- and 2-year local recurrence rate (LRR) and distant metastasis rate (DMR) after ablation

    Measured: Two years

  4. 1- and 2-year disease-free survival (DFS) and overall survival (OS) rates

    The percentage of patients who were without disease or still alive at the 1- and 2-year time point since the first cycle of treatment. The end point of observation is death due to tumor.

    Measured: Two years

  5. Median Disease-free survival (mDFS)

    median disease-free survival of patients after ablation

    Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2020
  2. Study start15 Dec 2020
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Evaluate the safety and tolerability of radiofrequency ablation combined with PD-1 monoclonal antibody in the treatment of patients with hepatocellular carcinoma.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04652440
Sponsor's protocol ID
B2020-197-01
Status last verified
Apr 2023
First submitted
27 Oct 2020
Last updated
19 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Will share the data on https://www.researchdata.org.cn/default.aspx.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PD-1 monoclonal antibody and Radiofequencey or microwave ablation in people with Hepatocellular Carcinoma, run by Sun Yat-sen 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 11 inclusion and 21 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 19 Apr 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Min-Shan Chen, Ph.D. (+86-20-87343115, chenmsh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure Safety (time frame: from the start of PD-1 monoclonal antibody therapy to 90 days after treatment). 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?

On the ClinicalTrials.gov record for NCT04652440.

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 19 Apr 2023.

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Ablation Combined With PD-1 in HCC: Phase II Study | AzTrials