Clinical trial · Observational
Efficacy of Target - Immunotherapy and XELOX Chemotherapy for Advanced HCC
Efficacy Analysis of the Combined Target - Immunotherapy and XELOX Chemotherapy Regimen in the Treatment of Advanced Hepatocellular Carcinoma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced HCC | — | UNRESOLVED | — |
| Chemotherapy | — | UNRESOLVED | — |
| Efficacy and Safety | — | UNRESOLVED | — |
| Immunotherapy | — | UNRESOLVED | — |
| Systemic Therapy | — | UNRESOLVED | — |
| Targeted Therapy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti PD-1 | Drug | — | UNRESOLVED |
| TKI | Drug | — | UNRESOLVED |
| XELOX chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Treatment group
- description
- TKI+PD-1 antibody +XELOX chemotherapy
- interventionNames
- Drug: TKI
- Drug: anti PD-1
- Drug: XELOX chemotherapy
Primary outcomes (1)
- 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 (4)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available