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

NCT06420440 | Recruiting Phase 2

• 1 other identifier: Neoadj-Net01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

HCC

Keywords

Hepatocellular carcinoma; Neoadjuvant tehrapy; recurrence; Deep learning

Outcome Measures

Primary Outcomes (1)

• Median event-free survival (EFS)

  EFS is defined as the time from randomization to disease recurrence and/or disease progression or death from any cause.

  From date of randomization until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months.

Secondary Outcomes (2)

• Safety Assessment

  Baseline up to 12 months

• Overall Survival (OS)

  From date of randomization until the date of death from any cause, assessed up to 60 months.

Study Arms (2)

Neoadjuvant therapy group

EXPERIMENTAL

Patients in the neoadjuvant group received neoadjuvant therapy prior to surgery (two cycles of HAIC combined with Tislelizumab and Lenvatinib), and adjuvant therapy (Tislelizumab for 8 cycles) after surgery.

Procedure: Hepatic arterial infusion chemotherapy; Drug: Lenvatinib; Drug: Tislelizumab; Procedure: Liver resection

Direct liver resection group

ACTIVE COMPARATOR

Patients in the control group underwent liver resection directly and received adjuvant therapy (Tislelizumab for 8 cycles) after surgery.

Procedure: Liver resection; Drug: Tislelizumab

Interventions

Hepatic arterial infusion chemotherapy PROCEDURE

Patients in the neoadjuvant group received two cycles of neoadjuvant hepatic arterial infusion chemotherapy (HAIC, adoption of the FOFOLX6 program, Folinic acid+5-fluorouracil+Oxaliplatin, 21 days between second HAIC treatments with a window of ±3 days)

Neoadjuvant therapy group

Lenvatinib DRUG

Patients in the neoadjuvant therapy group received Lenvatinib before surgery(Len was started before HAIC treatment, discontinued during HAIC treatment, and discontinued approximately two weeks before surgery, Oral 8 mg or 12mg once a day depending body weight).

Neoadjuvant therapy group

Tislelizumab DRUG

Patients in the neoadjuvant therapy group received two cycles of Tislelizumab therapy before surgery (First treatment with Tislelizumab was started 0-1 days after HAIC, 200 mg IV, followed by a second treatment 21 days later)

Neoadjuvant therapy group

Liver resection PROCEDURE

Patients in the neoadjuvant therapy group were evaluated for tumor status and surgical safety after neoadjuvant therapy, and eligible patients subsequently underwent surgical resection. Patients in the direct surgery group underwent liver resection.

Direct liver resection group; Neoadjuvant therapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Chen Xiaoping: lead

Study Sites (2)

Huapeng Sun

Xiangyang, Hubei, 430000, China

RECRUITING

Enyu Liu

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Interventions

lenvatinib; tislelizumab; Hepatectomy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

WanGuang Zhang

CONTACT

13886195965; wgzhang@tjh.tjmu.edu.cn

xiaoping Chen

CONTACT

027-83663400; chenxpchenxp@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)