Efficacy of Target - Immunotherapy and XELOX Chemotherapy for Advanced HCC (T+I+XELOX)

May 19, 2025 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Efficacy Analysis of the Combined Target - Immunotherapy and XELOX Chemotherapy Regimen in the Treatment of Advanced Hepatocellular Carcinoma.

In China, primary hepatocellular carcinoma (HCC) has high morbidity and mortality, imposing a heavy burden on the public. Surgical resection is an effective treatment, but as HCC is often latent, less than 30% of patients are suitable for surgery at first diagnosis. So systemic anti-tumor therapy is crucial for advanced HCC. Small-molecule targeted drugs like lenvatinib and sorafenib are NCCN-recommended first-line drugs for advanced HCC. The combination of targeted drugs and immune checkpoint inhibitors can prolong overall survival with good safety. The "2024 Guidelines for HCC Diagnosis and Treatment" shows that platinum-containing chemotherapy is a preferred systemic treatment for advanced HCC. However, in real-world practice, the efficacy and safety of the combination of targeted-immunotherapy and chemotherapy regimen for advanced HCC remain unclear.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a retrospective cohort study aimed at evaluating the efficacy and safety of TKI + PD-1 inhibitor + XELOX chemotherapy in the treatment of advanced HCC. The study included the clinical data of 68 patients with advanced HCC who could not undergo radical surgical resection and received first-line triple-drug therapy (lenvatinib as TKI + camrelizumab/ tislelizumab/ atezolizumab as PD-1 inhibitor + capecitabine and oxaliplatin as XELOX chemotherapy regimen) in the Hepatobiliary Surgery Department of Sun Yat-sen Memorial Hospital, Sun Yat-sen University from April 2022 to December 2024. Demographic information, imaging information, blood biochemistry, blood routine, alpha - fetoprotein and other information of patients were collected as baseline information. Subsequently, based on the RECIST v1.1 standard, the objective response rate (ORR) evaluated by the researchers was set as the primary endpoint, and the surgical conversion rate, overall survival (OS), progression - free survival (PFS), and the incidence of adverse events were analyzed as secondary endpoints.

Study Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sen Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with unresectable liver cancer

Description

Inclusion Criteria:

  1. Be aged 18 years or older and be diagnosed with HCC by histology, cytology, or imaging studies.
  2. Have HCC with a clinical stage corresponding to Barcelona Clinic Liver Cancer (BCLC) stage C.
  3. Have not undergone systemic treatment previously, and initially receive the targeted - immunotherapy combined with XELOX chemotherapy regimen (lenvatinib + Sintilimab or Camrelizumab or Tislelizumab + Capecitabine + Oxaliplatin) upon the diagnosis of HCC.
  4. Have a liver function classified as Child - Pugh grade A or B.
  5. Have an ECOG PS score of 0 or 1.

Exclusion Criteria:

  1. Experienced rupture and bleeding of esophageal or gastric varices within the past six months.
  2. Imaging findings indicate the presence of main portal vein invasion in hepatocellular carcinoma.
  3. Imaging results show inferior vena cava involvement in hepatocellular carcinoma.
  4. Imaging examinations reveal cardiac involvement in hepatocellular carcinoma.
  5. Pregnancy and lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment group
TKI+PD-1 antibody +XELOX chemotherapy
Drug: TKI
Lenvatinib
Drug: anti PD-1
Sintilimab or Camrelizumab or Tislelizumab
Drug: XELOX chemotherapy
Capecitabine and Oxaliplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate
Time Frame: from the patient's first medication use to the 6th treatment cycle, with each cycle lasting for 21 days
from the patient's first medication use to the 6th treatment cycle, with each cycle lasting for 21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: From the date of assignment to the date of death from any cause (or the date of the last follow-up if the patient was alive), with an assessment period of up to 12 months
From the date of assignment to the date of death from any cause (or the date of the last follow-up if the patient was alive), with an assessment period of up to 12 months
Progression Free Survival
Time Frame: From the date of assignment to progression according to RECIST 1.1 or death from any cause, whichever occurred first, with an assessment period of up to 12 months.
From the date of assignment to progression according to RECIST 1.1 or death from any cause, whichever occurred first, with an assessment period of up to 12 months.
Adverse event incidence rate
Time Frame: from the first cycle after treatment to 90 days after the last cycle.
from the first cycle after treatment to 90 days after the last cycle.
Surgical conversion rate
Time Frame: From the date of starting treatment to the date of receiving surgical resection, assessed up to 21 days
From the date of starting treatment to the date of receiving surgical resection, assessed up to 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

April 1, 2025

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

January 16, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

February 10, 2025

Study Record Updates

Last Update Posted (Estimated)

May 20, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TKI+PD-1+XELOX-HCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chemotherapy

Clinical Trials on TKI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe