← Back to all trials
Not Yet Recruiting
NCT07684040
A Study of Combination Therapy in Patients With Resectable Liver Cancer
Conditions: Liver Cancer (Primary and Metastatic)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 68
Sponsor: Affiliated Hospital of Guangdong Medical University
Location: Affiliated Hospital of Guangdong Medical University Zhanjiang Guangdong
Summary
This is a prospective, single-arm clinical study designed to evaluate the efficacy and safety of an initial combination treatment strategy followed by surgery in patients with cancer. Eligible participants will receive combination therapy prior to surgical intervention. Patients who meet predefined surgical criteria will undergo hepatic resection. Following surgery, additional treatment may be administered according to the investigator's assessment. The primary objective is to evaluate time to treatment failure (TTF). Secondary objectives include evaluation of pathological response, resection outcomes, progression-related outcomes, survival outcomes, and safety.
Eligibility Criteria
Inclusion Criteria:
* 1\. Voluntarily signed written informed consent.
* 2\. Age ≥18 years; male or female.
* 3\. Histologically, cytologically, or clinically confirmed hepatocellular carcinoma (HCC) according to EASL/AASLD criteria.
* 4\. CNLC stage Ib, IIa, IIb, or IIIa HCC (excluding patients with main portal vein tumor thrombus).
* 5\. Presence of vascular invasion and no extrahepatic metastasis, including PVTT (Vp1-Vp3), HVTT, or IVCTT.
* 6\. No prior systemic treatment for HCC, including chemotherapy, targeted therapy, or immunotherapy.
* 7\. Child-Pugh class A liver function.
* 8\. ECOG performance status 0-1.
* 9\. Adequate organ function:
1. ANC ≥1.5 × 10\^9/L; Platelet count ≥75 × 10\^9/L; Hemoglobin ≥90 g/L.
2. Albumin ≥30 g/L; Total bilirubin ≤1.5 × ULN; ALT, AST, and ALP ≤5 × ULN; Serum creatinine ≤1.5 × ULN or creatinine clearance \>50 mL/min.
3. INR ≤2.3 or PT prolongation ≤6 seconds.
4. Urine protein \
Source: ClinicalTrials.gov (NCT07684040). StuddyBuddy aggregates publicly available trial information.