Efficacy of Target - Immunotherapy and XELOX Chemotherapy for Advanced HCC

NCT06818097 | Completed

• 1 other identifier: TKI+PD-1+XELOX-HCC
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced HCC; Systemic Therapy; Chemotherapy; Immunotherapy; Targeted Therapy; Efficacy and Safety

Keywords

TKI; XELOX; advanced HCC; PD-1 antibody

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  from the patient's first medication use to the 6th treatment cycle, with each cycle lasting for 21 days

Secondary Outcomes (4)

• Overall Survival

  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

  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

  from the first cycle after treatment to 90 days after the last cycle.

• Surgical conversion rate

  From the date of starting treatment to the date of receiving surgical resection, assessed up to 21 days

Study Arms (1)

Treatment group

TKI+PD-1 antibody +XELOX chemotherapy

Drug: TKI; Drug: anti PD-1; Drug: XELOX chemotherapy

Interventions

TKI DRUG

Lenvatinib

Treatment group

anti PD-1 DRUG

Sintilimab or Camrelizumab or Tislelizumab

Treatment group

XELOX chemotherapy DRUG

Capecitabine and Oxaliplatin

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with unresectable liver cancer

You may qualify if:

• Be aged 18 years or older and be diagnosed with HCC by histology, cytology, or imaging studies.
• Have HCC with a clinical stage corresponding to Barcelona Clinic Liver Cancer (BCLC) stage C.
• 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.
• Have a liver function classified as Child - Pugh grade A or B.
• Have an ECOG PS score of 0 or 1.

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Interventions

spartalizumab

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: February 10, 2025
• Study Start: October 1, 2021
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)