Multimodal Thermal Therapy With Targeted and Immunotherapy for Untreated Unresectable HCC
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZhejiang University
About this trial
Multimodal Thermal Therapy combined with targeted therapy and immunotherapy versus targeted therapy and immunotherapy alone for systemically untreated unresectable hepatocellular carcinoma (HCC)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Age 18-80, regardless of gender;
Diagnosed with unresectable HCC by imaging or histology, BCLC stage B or C;
No prior systemic immunotherapy, chemotherapy, targeted therapy, or other systemic drug treatments for HCC;
Presence of an image-evaluable lesion intended for ablation without prior local ablation therapy, with the maximum diameter of the target tumor ≤5 cm;
Disqualifiers
• Invasion of the main portal vein;
Diffuse hepatocellular carcinoma;
The hepatic lesion occupies more than 50% of the liver volume.
Patients with a history or current diagnosis of brain metastases whose symptoms are not fully controlled (i.e., persistent or worsening symptoms, or requiring adjustments to symptomatic treatment to maintain symptom relief);
Trial design
Design model
Parallel
Treatments tested in this trial
Multimodal Thermal Therapy
DeviceMultimodal Thermal Therapy (MTT) is an advanced ablation technique that utilizes an integrated microprobe to combine liquid nitrogen freezing with radiofrequency heating. This dual-action process creates a rapidly shifting temperature field and significant tissue stress, leading to the complete destruction of tumor cells and their associated blood vessels. Beyond local tumor removal, the procedure acts as an "in situ vaccine" by releasing tumor-associated antigens and danger signals into the bloodstream, which activates a systemic and durable anti-tumor immune response.
Targeted and Immune Drugs
DrugIn this research, systemic treatment specifically refers to the combination of targeted therapies and immune checkpoint inhibitors, such as PD-1 inhibitors. These drugs are selected based on their approval by the NMPA for liver cancer treatment and the specific clinical needs of the patient. The primary role of the immune drugs is to block immune checkpoints, which prevents the tumor from escaping the body's defenses and significantly enhances the natural anti-tumor function of T cells. Complementing this, the targeted drugs-often anti-angiogenic agents-work to inhibit tumor blood vessel growth and improve the overall immune microenvironment. When used together, they create a synergistic "dual" effect: the targeted drugs optimize the environment for immune cell infiltration while the immune drugs activate T cells to more effectively attack the cancer.
Treatment groups
166 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS) per mRECIST
Progression-free survival (PFS) was defined as the interval from randomization to initial confirmed disease progression or all-cause death, whichever came first, with tumor assessments conducted per mRECIST by on-site investigators.
Time frame
Up to ~24 months.Secondary outcomes
1
Objective Response Rate (ORR) per mRECIST
ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of any intratumoral arterial enhancement in all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of viable \[enhancement in the arterial phase\] target lesions, taking as reference the baseline sum of the diameters of target lesions), with tumor assessments conducted per mRECIST by on-site investigators.
Time frame
Up to ~24 months.2
Objective Response Rate (ORR) per RECIST 1.1
Objective response rate (ORR) was defined as the proportion of participants achieving confirmed complete response or partial response, with tumor assessments conducted per RECIST 1.1 by on-site investigators.
Time frame
Up to ~24 months.3
Progression-free survival (PFS) per RECIST 1.1
Progression-free survival (PFS) was defined as the interval from randomization to initial confirmed disease progression or all-cause death, whichever came first, with tumor assessments conducted per RECIST 1.1 by on-site investigators.
Time frame
Up to ~24 months.4
Overall Survival
Overall survival (OS) was defined as the time from randomization to all-cause death, with outcome assessments conducted by on-site investigators.
Time frame
Up to ~36 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: