Biomarker and Mechanism Study of Systemic Therapy in Unresectable HCC
ConditionHepatocellular Carcinoma
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital
About this trial
The goal of this observational study is to evaluate the safety and efficacy of systemic therapies and identify predictive molecular biomarkers in patients with intermediate to advanced stage or unresectable hepatocellular carcinoma (HCC).
The main questions it aims to answer are:What is the objective response rate (ORR) of systemic therapy regimens in this patient population? Which 3-4 specific biomarkers (including tumor or peripheral blood-derived genes, proteins, ctDNA, and immune cell subsets) can reliably predict the efficacy of systemic treatment?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically confirmed hepatocellular carcinoma (HCC), or meeting the clinical diagnostic criteria of the "Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition)" issued by the National Health Commission of China.
Assessed by the investigator as unsuitable for surgical resection, or having intermediate to advanced stage HCC. Intermediate to advanced HCC is defined as Barcelona Clinic Liver Cancer (BCLC) stage B/C or China Liver Cancer (CNLC) stage IIa/IIb/IIIa/IIIb.
Child-Pugh liver function class A or a score of 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
Willing to receive targeted therapy combined with immunotherapy or dual immunotherapy, and signed the informed consent form (applicable to the prospective cohort).
Disqualifiers
Pathological diagnosis of mixed liver cancer, fibrolamellar hepatocellular carcinoma, or other non-hepatocellular malignant tumor components.
Previous or concurrent other malignant tumors, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma.
History of organ transplantation or hepatic encephalopathy. Known allergy to the selected targeted therapy drugs or immunotherapy drugs or drug excipients, or previous severe allergic reactions to other monoclonal antibodies.
History of gastrointestinal perforation and/or fistula within the past 6 months, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive intestinal resection (partial colon resection or extensive small bowel resection complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea.
Trial population
The study population consists of patients with intermediate to advanced stage or unresectable hepatocellular carcinoma (HCC) confirmed by histology, cytology, or clinical diagnostic criteria. Eligible patients must have an ECOG performance status of 0 to 2 and well-preserved liver function, defined as Child-Pugh class A or a score of 7. The population includes patients who are scheduled to receive standard systemic therapies, such as targeted therapy combined with immunotherapy or dual immunotherapy, either alone or in combination with local therapies like transcatheter arterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Systemic therapy
DrugIncluding regimens such as Atezolizumab + Bevacizumab, Nivolumab + Ipilimumab.
Local therapy
Procedure/SurgeryIncluding therapy such as TACE, HAIC
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Systemic Therapy Cohort1 intervention
Group B: TACE/HAIC + Systemic Therapy Cohort2 interventions
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR) Assessed by RECIST v1.1 and HCC mRECIST Criteria
The ORR will be evaluated according to RECIST v1.1 and HCC mRECIST criteria, defined as the sum of complete response (CR) and partial response (PR) in patients with at least one measurable lesion.defined as the sum of complete response (CR) and partial response (PR) in patients with at least one measurable lesion.
Time frame
Up to 2 years (assessed every 8 ± 2 weeks)2
Levels of Predictive Biomarkers Assessed by Multi-Omics Sequencing and Single Cell RNA Sequencing
Identify 3-4 predictive biomarkers for the efficacy of HCC systemic therapy, including genes, proteins, ctDNA, and immune cell subsets based on tumor tissue or peripheral blood.
Time frame
Up to 2 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: