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NCT06420440RecruitingPhase 2

Neoadjuvant Therapy in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model

Efficacy and Safety of Neoadjuvant HAIC Combined With Tislelizumab and Lenvatinib in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model: a Multicenter Randomized Controlled Trial.

Source: ClinicalTrials.gov · Last updated 1 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
160 (estimated)
First submitted
14 May 2024
Start date
1 Jun 2024
Primary completion date
31 May 2026
Lead sponsor
Chen Xiaoping
NCT number
NCT06420440

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 160
  • From 1 Jun 2024 to the primary completion date, 31 May 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Active infection.

Lab values

  • 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.).
  • Other significant clinical and laboratory abnormalities that affect the safety evaluation.

Other

  • Pregnant and lactating women.
  • Inability to follow the study protocol for treatment or follow up as scheduled.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Enyu Liu
Coordinator of this site? Confirm its status
JinanChinaRecruiting
Huapeng Sun
Coordinator of this site? Confirm its status
XiangyangChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.