NCT06876753 Regional Lymph Node Metastasis and Survival Outcomes in Advanced HCC
| NCT ID | NCT06876753 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhongda Hospital |
| Condition | Hepatocellular Carcinoma (HCC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2018-06-01 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2018-06-01 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology; 2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of extrahepatic spread; 3. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy); 4. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval; 5. TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment (within 3 months); 6. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment; 7. Has repeated measurable intrahepatic lesions; Exclusion Criteria: 1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible; 2. Unable to meet criteria of combination timeframe described above; 3. Child-Pugh C or PS \> 2 or Severe hepatic encephalopathy
Contact & Investigator
Gao-jun Teng, M.D
PRINCIPAL INVESTIGATOR
Zhongda hospital, Southeast university, Nanjing, China
Frequently Asked Questions
Who can join the NCT06876753 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hepatocellular Carcinoma (HCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06876753 currently recruiting?
Yes, NCT06876753 is actively recruiting participants. Contact the research team at gjteng@vip.sina.com for enrollment information.
Where is the NCT06876753 trial being conducted?
This trial is being conducted at Nanjing, China, Nanjing, China.
Who is sponsoring the NCT06876753 clinical trial?
NCT06876753 is sponsored by Zhongda Hospital. The principal investigator is Gao-jun Teng, M.D at Zhongda hospital, Southeast university, Nanjing, China. The trial plans to enroll 300 participants.
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