Thermal Ablation Followed by Immunotherapy for HCC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-15

Study Completion Date

2023-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the safety and efficacy of immunotherapy toripalimab (anti-PD-1 mAb) combined with thermal ablation in patients with Hepatocellular Carcinoma (HCC).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Adjuvant Immunotherapy With Toripalimab Following Curative-intent Ablation for Recurrent Hepatocarcinoma

NCT05240404

Hepatocellular Carcinoma

UNKNOWN PHASE2

Hyperthermia Combined With Immune Checkpoint Inhibitors in the Treatment of Advanced Gastrointestinal Malignancies With Liver Metastases

NCT07118566

Gastrointestinal Cancer Immunotherapy Liver Metastasis

NOT_YET_RECRUITING PHASE2

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

NCT04652440

Hepatocellular Carcinoma

UNKNOWN PHASE1/PHASE2

Immune Checkpoint Inhibitor Monotherapy or Combined With Molecular Targeted Drugs / Locoregional Therapy in the Treatment of Hepatocellular Carcinoma

NCT05609695

Immune Checkpoint Inhibitor Monotherapy or Combined With Molecular Targeting Drugs / Locoregional Therapy for Hepatocellular Carcinoma

UNKNOWN

Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Radical Resection

NCT03859128

Hepatocellular Carcinoma

UNKNOWN PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

1.1 Primary Objective \& Hypothesis Determine the safety and efficacy of radiofrequency ablation (RFA)/microwave ablation (MWA) followed by toripalimab for advanced HCC by establishing the rates of toxicity that occur within 6 months after ablation. Hypothesis: Thermal ablation followed by toripalimab will have similar toxicity to toripalimab monotherapy. Thermal ablation enhances antitumor immune response and improves the best overall response rate compared to historical controls with toripalimab alone.

1.2 Secondary Objectives and Hypotheses Estimate the progression-free survival, and overall survival. Hypothesis: Disease control and survival will be better than that observed with toripalimab monotherapy.

1.3 Exploratory Objectives Explore changes in inflammatory biomarkers (including, but not limited to CD8+/Treg ratio, total CD4+ counts, total lymphocyte count) in pretreatment and on-treatment serially collected peripheral blood samples. Hypothesis: Changes in inflammatory biomarkers after thermal ablation may correlate with a more favorable response to immunotherapy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma Non-resectable

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Toripalimab monotherapy

Toripalimab is administrated intravenously (240mg, Q3W) continuously until documented disease progression, discontinuation due to toxicity withdrawal of consent or the study ends.

Group Type ACTIVE_COMPARATOR

Toripalimab

Intervention Type DRUG

Protocol 1. Patients received toripalimab (240mg, Q3W) as monotherapy.

Protocol 2. Patients received toripalimab (240mg, Q3W) on day 3 after ablation.

Protocol 3. Patients received toripalimab (240mg, Q3W) on day 14 after ablation.

Thermal ablation plus toripalimab

One to five target lesions will be ablated completely. Toripalimab therapy will be initiated on day 3 or day 14 after ablation ((240mg, Q3W) ). Toripalimab is administrated continuously until documented disease progression, discontinuation due to toxicity withdrawal of consent or the study ends.

Group Type EXPERIMENTAL

Thermal ablation

Intervention Type PROCEDURE

Radiofrequency ablation or microwave ablation is performed under CT or ultrasound guidance for one to five target lesions.

Toripalimab

Intervention Type DRUG

Protocol 1. Patients received toripalimab (240mg, Q3W) as monotherapy.

Protocol 2. Patients received toripalimab (240mg, Q3W) on day 3 after ablation.

Protocol 3. Patients received toripalimab (240mg, Q3W) on day 14 after ablation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Thermal ablation

Radiofrequency ablation or microwave ablation is performed under CT or ultrasound guidance for one to five target lesions.

Intervention Type PROCEDURE

Toripalimab

Protocol 1. Patients received toripalimab (240mg, Q3W) as monotherapy.

Protocol 2. Patients received toripalimab (240mg, Q3W) on day 3 after ablation.

Protocol 3. Patients received toripalimab (240mg, Q3W) on day 14 after ablation.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Immunotherapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* With hepatocellular carcinoma, who meet the clinical diagnostic criteria of Primary HCC confirmed by histopathology, cannot undergo radical resection or radical ablation, and fail or intolerable to first-line systemic therapy
* Be willing and able to provide written informed consent for the trial.
* Be ≥ 18 years of age on day of signing informed consent.
* Have ECOG performance status 0-1.
* Pretreatment CT chest /abdomen /pelvis within 14 days of protocol enrollment.
* Pathologic diagnosis of hepatocellular carcinoma (including fibrolamellar variants and biphenotypic tumors with a HCC component).
* Child Pugh Class A or B (score =7)
* Deemed ineligible for curative intent therapy with surgical resection or locoregional treatment or that had progression with at least 3 lesions thereafter.
* At least one lesion can be completely ablated by radiofrequency/microwave ablation.
* The the maximum diameter of a single lesion is less than 10 cm. Tumors account for less than 50% of the liver volume.
* Patients with extrahepatic disease are eligible.
* Progress or intolerance following at least one systemic treatment regimen.
* Have measurable disease based on RECIST 1.1.
* Demonstrate adequate organ function. Adequate Organ Function Laboratory Values System Laboratory Value Hematological Platelets ≥ 50,000 /mL Hepatic Serum total bilirubin ≤ 3 mg/dL AST (SGOT) and ALT (SGPT) ≤ 5 X ULN.
* Subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 150 days after the last dose of study therapy (for women of child-bearing potential) or 210 days after the last dose of study therapy (for men who have partners of child-bearing potential).
* Have a life expectancy of greater than 3 months (in the opinion of the treating physician).

Exclusion Criteria

* Received local ablation or external beam radiation within 3 months .
* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at a dose of \>10 mg prednisone daily or equivalent at time of first dose of trial treatment.
* Has a known history of active TB (Bacillus Tuberculosis).
* Has a known additional malignancy that is progressing or requires active treatment.
* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with allografts (including liver transplants) are not eligible for this protocol.
* Has known history of, or any evidence of active, non-infectious pneumonitis.
* Has an active infection requiring systemic therapy.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
* Has received a live vaccine within 30 days of planned start of study therapy.
* Prior anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA4 immunotherapy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No