Regional Lymph Node Metastasis and Survival Outcomes in Advanced HCC
ConditionHepatocellular Carcinoma (HCC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorZhongda Hospital
About this trial
Tumor-draining lymph nodes play an important role in anti-tumor immune responses. In patients with hepatocellular carcinoma (HCC), however, the relationship between regional lymph node metastasis (LNM) and immunotherapy-based efficacy is unclear. This study aimed to evaluate whether extrahepatic LNM is associated with worse survival outcomes as compared to other metastatic sites in patients with advanced HCC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of extrahepatic spread;
Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
Disqualifiers
Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
Unable to meet criteria of combination timeframe described above;
Child-Pugh C or PS > 2 or Severe hepatic encephalopathy
Trial population
Patients with metastatic HCC who received TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapies under real-world practice conditions
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Overall Survival(OS)
OS is defined as the time from the initiation of any combination treatment to death due to any cause.
Time frame
up to approximately 2 yearsSecondary outcomes
1
Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST 1.1) or death due to any cause, whichever occurs first.
Time frame
up to approximately 2 years2
PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first.
Time frame
up to approximately 2 years3
Objective response rate(ORR) per RESCIST 1.1
ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.
Time frame
up to approximately 2 years4
ORR per mRECIST
ORR is defined as the proportion of patients with a documented CR or PR per mRECIST.
Time frame
up to approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov