Neoadjuvant Therapy in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model
Recruiting now · Phase 2
Conditions studied: HCC
In brief
Primary liver cancer is one of the most common malignant tumors in the world, and about 80%\~90% of primary liver cancers are pathologically characterized as hepatocellular carcinoma (HCC). Radical surgery is the main method for patients with HCC to obtain long-term survival. However, the early recurrence rate of high-risk HCC is very high, which seriously affects the overall therapeutic effect.
Key facts
- Study ID
- NCT06420440
- Run by
- Chen Xiaoping
- People needed
- 160
- Starts
- 2024-06-01
- Expected to finish
- 2027-05-31
- Last updated by the study team
- 2025-05-01
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aged 18-75.
- No previous local or systemic treatment for hepatocellular carcinoma.
- Child-Pugh liver function score ≤ 7.
- ECOG PS 0-1.
- No serious organic diseases of the heart, lungs, brain, kidneys, etc.
- Enhanced MRI determines that the tumor is technically resectable but at high risk for recurrence(BCLC-A tumor diameter more than or equal to 5cm; BCLC-B; BCLC-C) ; without distant metastasis.
- Pathologic type of hepatocellular carcinoma confirmed by puncture biopsy.
- Multimodal Deep Learning Model Screening Based on Pathology, Imaging, and Genetic Data Suggests Benefit from HAIC in Combination with Lenvatinib and PD-1 inhibitors.
You may not qualify if…
- Pregnant and lactating women.
- 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.).
- 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.
- Active infection.
- Other significant clinical and laboratory abnormalities that affect the safety evaluation.
- Inability to follow the study protocol for treatment or follow up as scheduled.
Where it is running
- Huapeng Sun — Xiangyang, Hubei, China (enrolling)
- Enyu Liu — Jinan, Shandong, China (enrolling)
Full record on ClinicalTrials.gov
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