Clinical trial NCT06818097: Efficacy of Target - Immunotherapy and XELOX Chemotherapy for Advanced HCC
Official title: Efficacy Analysis of the Combined Target - Immunotherapy and XELOX Chemotherapy Regimen in the Treatment of Advanced Hepatocellular Carcinoma.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced HCC
Systemic Therapy
Chemotherapy
Immunotherapy
Targeted Therapy
Efficacy and Safety
Keywords: TKI
XELOX
advanced HCC
PD-1 antibody
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with unresectable liver cancer

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate
timeFrame: from the patient's first medication use to the 6th treatment cycle, with each cycle lasting for 21 days
Secondary outcomes:
measure: Overall Survival
timeFrame: 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
measure: Progression Free Survival
timeFrame: 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.
measure: Adverse event incidence rate
timeFrame: from the first cycle after treatment to 90 days after the last cycle.
measure: Surgical conversion rate
timeFrame: From the date of starting treatment to the date of receiving surgical resection, assessed up to 21 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sen Memorial Hospital
state: Guangdong
Study officials:
References: