Clinical trial · Interventional
Multimodal Thermal Therapy With Targeted and Immunotherapy for Untreated Unresectable HCC
Multimodal Thermal Therapy With Targeted Therapy and Immunotherapy Versus Targeted Therapy and Immunotherapy Alone for Systemically Untreated Unresectable (HCC): a Prospective, Multicenter, Open-label, Randomized Controlled Trial.
NCT07596134CI-TRIAL-00112450HLP1-1331not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
Multimodal Thermal Therapy combined with targeted therapy and immunotherapy versus targeted therapy and immunotherapy alone for systemically untreated unresectable hepatocellular carcinoma (HCC)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unresectable Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multimodal Thermal Therapy | Device | — | UNRESOLVED |
| Targeted and Immune Drugs | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Multimodal Thermal Therapy Combined with Targeted and Immune Drugs
- interventionNames
- Device: Multimodal Thermal Therapy
- Drug: Targeted and Immune Drugs
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- Targeted and Immune Drugs
- interventionNames
- Drug: Targeted and Immune Drugs
Primary outcomes (1)
- measure
- Progression-free survival (PFS) per mRECIST
- timeFrame
- Up to ~24 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * • 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; * Child-Pugh score ≤7; * ECOG-PS score of 0-1. Exclusion Criteria: * • 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); * Extensive distant metastasis confirmed by imaging (e.g., chest/abdominal CT/MRI, whole-body bone scan, PET-CT, etc.), including but not limited to diffuse lung metastasis, multiple bone metastases, extensive abdominal/peritoneal metastasis, or other multi-organ metastases, where the investigator assesses that the extent of metastasis may compromise the safe administration of study treatment or affect efficacy and safety evaluations; * Prior local therapy with the last treatment administered less than 4 weeks before enrollment; * Involvement of major blood vessels such as the hepatic vein or inferior vena cava; * Uncontrolled active infection; * Renal dysfunction with serum creatinine \>176.8 μmol/L or creatinine clearance \<30 mL/min; * Uncorrectable coagulation abnormalities: platelets \<50×10⁹/L, prothrombin time \>18 seconds, prothrombin activity \<40%, and uncorrectable; * History of esophageal or gastric variceal bleeding without effective treatment via endoscopy, intervention, or surgery; * Patients with active psychiatric disorders; * Patients receiving or requiring systemic glucocorticoids (e.g., prednisone, dexamethasone) at a dose ≥10 mg/day (prednisone equivalent) or other immunosuppressive drugs (e.g., cyclosporine, tacrolimus, methotrexate) within 14 days prior to enrollment; topical, inhaled, or ophthalmic glucocorticoid use that does not affect systemic immune function may be allowed at the investigator's discretion; * History or current diagnosis of malignancies other than the target tumor in this study (excluding cured low-grade malignancies such as basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ). For low-grade malignancies, eligibility will be determined by the investigator; * Pregnant or breastfeeding women, or women of childbearing potential planning pregnancy during the study or within 3 months after treatment completion; * Expected survival \<3 months; * Patients deemed unsuitable for participation by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.