Exploratory Cohort Study and Mechanistic Research on Individualized Comprehensive Treatment After Standard Treatment for Advanced Hepatocellular Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This project is a prospective, multi-center, multi-cohort exploratory clinical study. It focuses on patients with advanced hepatocellular carcinoma who experience disease progression after first-line standard therapy. Based on different patterns of disease progression, patients will receive relevant systemic treatments, either with or without local interventional therapy. The primary endpoint is progression-free survival (PFS), while secondary endpoints include overall survival (OS), 1-year OS rate, objective response rate (ORR), disease control rate (DCR), duration of remission (DOR), and safety. Additionally, the study will explore the correlation between patients' clinical pathological characteristics, serum biomarkers, and clinical efficacy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years old, male or female

• Hepatocellular carcinoma patients diagnosed by cytology or tissue puncture, or who meet clinical diagnostic criteria and cannot be treated with radical treatment (radical surgery, ablation, radiotherapy, etc.)

• Disease progression after first-line targeted combined immune system therapy (as per RECIST1.1 criteria)

• Life expectancy exceeds 3 months

• ECOG physical condition score 0\

⁃ 1

• Women of childbearing age must have a serum pregnancy study done within 7 days before the first medication, and the result is negative. Female subjects of reproductive age and male subjects whose partners are women of reproductive age must consent to contraception within 24 weeks from the date of signing the informed consent to the last administration of the study drug

• Before the first dose of the investigational drug, the laboratory test values met the following conditions: ①blood routine (no blood transfusion within 14 days before screening, no hematopoietic stimulating drug correction) : white blood cell count (WBC) ≥ 2.0 × 109/L; platelet (PLT) ≥ 60× 109/L; hemoglobin content (HGB) ≥ 8.0 g/dL; ② Liver function: aspartate transferase (AST) ≤ 2.5x ULN; alanine aminotransferase (ALT) ≤ 2.5 x ULN; Serum total bilirubin (TBIL) ≤ 1.5 x ULN (except Gilbert syndrome total bilirubin ≤ 3.0 mg/dL); ③ Renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance rate (CrCl) ≥ 50 mL/minute; ④ Coagulation function: international normalized ratio (INR) ≤ 1.5 x ULN, activated partial thromboplastin time (APTT) ≤ 1.5 x ULN (only for patients who are not currently receiving anticoagulant therapy, patients who are currently receiving anticoagulant therapy should receive a steady dose of anticoagulant therapy)

• The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up

Locations
Other Locations
China
China Pharmaceutical University Affiliated Nanjing Tianyinshan Hospital
RECRUITING
Nanjing
Contact Information
Primary
Chen Xun
mxrlwx19911990@163.com
+86-13851670770
Time Frame
Start Date: 2025-05-22
Estimated Completion Date: 2028-03-15
Participants
Target number of participants: 300
Treatments
Experimental: Arm 1
XELOX/FOLFOX4+ Adebelizumab + Apatinib+Icaritin
Experimental: Arm 2
Adebelizumab + Apatinib+Icaritin
Experimental: Arm 3
SHR1701+ Apatinib+Icaritin
Experimental: Arm 4
QL1706+ Apatinib+Icaritin
Experimental: Arm 5
The original targeted combination immunotherapy+HAIC
Experimental: Arm 6
SHR1701+ Apatinib+Icaritin,intrahepatic progression
Experimental: Arm 7
QL1706+ Apatinib+Icaritin,extrahepatic progression
Experimental: Arm 8
SHR1701+Bevacizumab+Icaritin
Experimental: Arm 9
QL1706+Bevacizumab+Icaritin
Experimental: Arm 10
Local treatment of oligometastases (such as radiotherapy, RFA, etc.) + the original targeted and immunotherapy.
Related Therapeutic Areas
Sponsors
Leads: Nanjing Tianyinshan Hospital

This content was sourced from clinicaltrials.gov