Advanced HCCT+I+XELOXNCT06818097
Efficacy of Target - Immunotherapy and XELOX Chemotherapy for Advanced HCC
An observational study of Advanced HCC and Systemic Therapy, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced HCC, Systemic Therapy, Chemotherapy
- What is being tested?
- TKI, anti PD-1 and XELOX chemotherapy
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 1 Apr 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with unresectable liver cancer
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Advanced HCC, Systemic Therapy, Chemotherapy, Immunotherapy, Targeted Therapy, Efficacy and Safety
- Being tested
- TKI, anti PD-1, XELOX chemotherapy
- Keywords
- TKI, XELOX, advanced HCC, PD-1 antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKIDrug
Lenvatinib
anti PD-1Drug
Sintilimab or Camrelizumab or Tislelizumab
XELOX chemotherapyDrug
Capecitabine and Oxaliplatin
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | TKI+PD-1 antibody +XELOX chemotherapy Receives: Drug: TKI; Drug: anti PD-1; Drug: XELOX chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: from the patient's first medication use to the 6th treatment cycle, with each cycle lasting for 21 days
Secondary outcomes (4)
Overall Survival
Measured: 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
Measured: 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
Measured: from the first cycle after treatment to 90 days after the last cycle.
Surgical conversion rate
Measured: From the date of starting treatment to the date of receiving surgical resection, assessed up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start1 Oct 2021
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced HCCStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 68 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818097
- Sponsor's protocol ID
- TKI+PD-1+XELOX-HCC
- Acronym
- T+I+XELOX
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Analysis of the Combined Target - Immunotherapy and XELOX Chemotherapy Regimen in the Treatment of Advanced Hepatocellular Carcinoma.
- ClinicalTrials.gov ID
- NCT06818097
- Acronym / sponsor ID
- T+I+XELOX / TKI+PD-1+XELOX-HCC
- Conditions
- Advanced HCC, Systemic Therapy, Chemotherapy, Immunotherapy, Targeted Therapy, Efficacy and Safety
- Keywords
- TKI, XELOX, advanced HCC, PD-1 antibody
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Drug: TKI, Drug: anti PD-1, Drug: XELOX chemotherapyTKI+PD-1 antibody +XELOX chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with unresectable liver cancer
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TKILenvatinib | Drug | Treatment group |
| anti PD-1Sintilimab or Camrelizumab or Tislelizumab | Drug | Treatment group |
| XELOX chemotherapyCapecitabine and Oxaliplatin | Drug | Treatment group |
Primary outcome
Objective Response Rate
Time frame: from the patient's first medication use to the 6th treatment cycle, with each cycle lasting for 21 days
4 secondary outcomes
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
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.
Adverse event incidence rate
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced HCC and Systemic Therapy, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: from the patient's first medication use to the 6th treatment cycle, with each cycle lasting for 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.