Clinical trial · Interventional
Precision Treatment of Unresectable HCC Guided by Multi-omics Deep Learning Models
Precision Treatment of Unresectable Liver Cancer Based on Multi-omics Deep Learning Model: a Multi-center Prospective Single-arm Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Surgery is the main curative treatment for hepatocellular carcinoma(HCC) patients, but 70%-80% of HCC patients are in the middle and advanced stages at the time of diagnosis and cannot be surgically resected. Local and systemic therapy are the main treatments for unresectable HCC. Two recent trials of HAIC combined with PD-1 monoclonal antibody and targeted therapy reported objective response rates (ORR) as high as 43.3% to 77.1%.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HCC | — | UNRESOLVED | — |
| Precision Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HAIC + Tislelizumab +lenvatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combined therapy group
- description
- All patients received HAIC combined with targeted therapy and immunotherapy
- interventionNames
- Drug: HAIC + Tislelizumab +lenvatinib
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- From the time of enrollment until disease progression, death, or the end of the study,assessed up to 60 months.
- description
- Objective response rate(ORR) was defined as the sum of cases with complete response (CR) and partial response (PR) which assessed by the mRESIST criteria.
Secondary outcomes (2)
- measure
- Overall survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18-75. 2. No previous local or systemic treatment for hepatocellular carcinoma. 3. Child-Pugh liver function score ≤ 7. 4. ECOG PS 0-1. 5. No serious organic diseases of the heart, lungs, brain, kidneys, etc. 6. Enhanced MRI determines that the tumor is technically unresectable. 7. Pathologic type of hepatocellular carcinoma confirmed by puncture biopsy. 8. Multimodal Deep Learning Model Screening Based on Pathology, Imaging, and Genetic Data Suggests Benefit from HAIC in Combination with Lenvatinib and PD-1 inhibitors. Exclusion Criteria: 1. Pregnant and lactating women. 2. Suffering from a condition that interferes with the absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, impaired absorption, etc.). 3. A history of gastrointestinal bleeding within the previous 4 weeks or a definite predisposition to gastrointestinal bleeding (e.g., known locally active ulcer lesions, fecal occult blood ++ or more, or gastroscopy if persistent fecal occult blood +) that has not been targeted, or other conditions that may have caused gastrointestinal bleeding (e.g., severe fundoplication/esophageal varices), as determined by the investigator. 4. Active infection. 5. Other significant clinical and laboratory abnormalities that affect the safety evaluation. 6. Inability to follow the study protocol for treatment or follow up as scheduled.
References
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