Regional Lymph Node Metastasis and Survival Outcomes in Advanced HCC
Launched by ZHONGDA HOSPITAL · Mar 10, 2025
Trial Information
Current as of July 21, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a type of liver cancer called hepatocellular carcinoma (HCC), specifically looking at how cancer that spreads to nearby lymph nodes affects survival chances. The researchers want to find out if having cancer spread to these lymph nodes makes it harder for patients to respond to treatments, compared to when the cancer spreads to other areas of the body. The trial is currently recruiting participants aged between 65 and 74 years.
To be eligible for the study, participants must have a confirmed diagnosis of advanced HCC that has spread outside the liver, and they should not have received any prior treatments for their cancer. Participants will receive a combination of specific therapies aimed at treating their cancer after certain procedures. Throughout the study, patients can expect close monitoring to evaluate their response to the treatment and overall health. This trial aims to gain a better understanding of how lymph node involvement impacts treatment outcomes, which could help improve care for future patients with advanced HCC.
Gender
ALL
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
About Zhongda Hospital
Zhongda Hospital, a leading medical institution affiliated with Southeast University in Nanjing, China, is dedicated to advancing healthcare through innovative research and clinical trials. With a robust focus on patient-centered care, the hospital combines cutting-edge facilities with a multidisciplinary team of experts to conduct a wide range of clinical studies. Zhongda Hospital is committed to enhancing medical knowledge and improving treatment outcomes across various specialties, fostering collaboration between researchers and healthcare professionals to ensure the highest standards of scientific rigor and ethical practice in all its clinical endeavors.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nanjing, Jiangsu, China
Patients applied
Trial Officials
Gao-jun Teng, M.D
Principal Investigator
Zhongda hospital, Southeast university, Nanjing, China
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported