Efficacy and Safety of Neoadjuvant Therapy in Patients With Resectable HCC Screened by a Multimodal Deep Learning Model.

NCT06311916 | Not Yet Recruiting Phase 4

• 1 other identifier: Neoadj-Net
• Study Type: interventional
• Target: 312
• Locations: 0 countries
• Sites: N/A

Brief Summary

Primary liver cancer is one of the most common malignant tumors in the world, and more than 90% of primary liver cancers are pathologically characterized as hepatocellular carcinoma (HCC). The intermediate stage (BCLC-B) HCC is highly heterogeneous, and there is no consensus on the treatment of this stage of the tumor in Western and Eastern countries. New tools are urgently needed to guide the choice of treatment options for patients with this stage of the tumor in order to reduce the risk of postoperative recurrence and the overall survival rate.

Conditions

HCC

Keywords

Hepatocellular carcinoma; Neoadjuvant tehrapy; recurrence; Deep learning

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  DFS defined as the time after surgical resection until tumor recurrence or death

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

Secondary Outcomes (1)

• Safety Assessment

  2 months

Study Arms (2)

Neoadjuvant therapy group

EXPERIMENTAL

Patients in the neoadjuvant therapy group received neoadjuvant therapy before undergoing liver resection.

Drug: HAIC + Tirelizumab +lenvatinib +liver resection

Direct surgical resection group

ACTIVE COMPARATOR

Patients in the control group undergoing liver resection directly.

Procedure: liver resection

Interventions

HAIC + Tirelizumab +lenvatinib +liver resection DRUG

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) + Tirelizumab (First treatment with Tirelizumab was started 0-1 days after HAIC, 200 mg IV, followed by a second treatment 21 days later)+ lenvatinib (Oral 8 mg or 12mg once a day depending body weight). Assessment of tumor status and surgical safety after receiving neoadjuvant therapy, and eligible patients then underwent surgical resection.

Also known as: Non

Neoadjuvant therapy group

liver resection PROCEDURE

Direct liver resection or laparoscopic liver resection depending on tumor status.

Direct surgical resection 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 stage is intermediate (BCLC stage B) and is safe for radical hepatectomy.
• 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.
• Tumor distribution in two liver lobes, diffuse growth, or other reasons why radical R0 resection is not possible.
• 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

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Interventions

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

Study Officials

• Xiaoping Chen

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

WanGuang Zhang

CONTACT

+8613886195965; wgzhang@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2024
• First Posted: March 15, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 15, 2024

Record last verified: 2024-03