Precision Treatment of Unresectable HCC Guided by Multi-omics Deep Learning Models

NCT06463444 | Recruiting Phase 1

• 1 other identifier: Precision01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

HCC; Precision Therapy

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  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.

  From the time of enrollment until disease progression, death, or the end of the study,assessed up to 60 months.

Secondary Outcomes (2)

• Overall survival

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

• Safety Assessment

  Baseline up to study termination, assessed up to 12 months.

Study Arms (1)

Combined therapy group

EXPERIMENTAL

All patients received HAIC combined with targeted therapy and immunotherapy

Drug: HAIC + Tislelizumab +lenvatinib

Interventions

HAIC + Tislelizumab +lenvatinib DRUG

All patients were treated with HAIC combined with tislelizumab and lenvatinib. 1. HAIC was adopted of the FOFOLX 6 program, Folinic acid+5-fluorouracil+Oxaliplatin, 21 days between second HAIC treatments with a window of ±3 days. 2. Lenvatinib was started before HAIC treatment, discontinued during HAIC treatment, Oral 8 mg or 12mg once a day depending body weight. 3. First treatment with Tislelizumab was started 0-1 days after HAIC, 200 mg IV, followed by a second treatment 21 days later.

Combined 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 unresectable.
• 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 (1)

Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Study Officials

• WanGuang Zhang

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

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 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: June 17, 2024
• Study Start: June 1, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)