Liver Cancer (Primary and Metastatic)
Conditions
Brief 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.
Interventions
DRUGHepatic Arterial Infusion Chemotherapy Combined with Adebrelimab Plus Rivoceranib
Surgery followed by Hepatic Arterial Infusion Chemotherapy Combined wit Adebrelimab plus Rivoceranib
Sponsors
Affiliated Hospital of Guangdong Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \<2+; if ≥2+, 24-hour urine protein \<1.0 g. * 10\. For patients with active HBV infection, effective antiviral therapy is required, with HBV DNA ≤2000 IU/mL or a ≥10-fold reduction after antiviral treatment. * 11\. Women of childbearing potential must have a negative pregnancy test before enrollment and agree to use effective contraception during the study and for 6 months after study completion. Male participants must also use effective contraception during the study and for 6 months after study completion.
Exclusion criteria
* 1\. Intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed hepatocellular carcinoma, fibrolamellar carcinoma, or any other active malignancy within the past 5 years (except HCC). * 2\. Severe allergy to iodinated contrast agents that prevents HAIC treatment. * 3\. Planned or prior organ transplantation or allogeneic bone marrow transplantation. * 4\. Treatment with another investigational drug within 28 days before study treatment. * 5\. Current or prior central nervous system metastases. * 6\. History of hepatic encephalopathy. * 7\. Current interstitial pneumonitis or interstitial lung disease. * 8\. Active autoimmune disease or history of autoimmune disease with risk of recurrence. * 9\. Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes within 14 days before study treatment. * 10\. Severe infection within 4 weeks before study treatment. * 11\. Gastrointestinal bleeding within 6 months before study treatment or a known risk of gastrointestinal bleeding. * 12\. Known hereditary or acquired bleeding disorders or thrombotic tendency. * 13\. Uncontrolled clinically significant cardiac disease or symptoms. * 14\. Moderate or severe ascites requiring therapeutic drainage or paracentesis. * 15\. Major vascular disease within 6 months before study treatment. * 16\. Inability to swallow oral medication, malabsorption syndrome, or any condition affecting gastrointestinal absorption. * 17\. Known hypersensitivity to any study drug, its excipients, monoclonal antibodies, or anti-angiogenic agents. * 18\. Any other serious acute or chronic medical condition, psychiatric disorder, or laboratory abnormality that may increase study risk, interfere with study results, or make the patient unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Treatment Failure | 24 months | Time from initiation of treatment to treatment failure, including disease progression resulting in inability to undergo surgery, recurrence/metastasis after surgery, or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 24 months | Overall survival (OS) after treatment, defined as the time from the start of treatment to death from any cause |
| R0 rate | 24 months | R0 rate, defined as the proportion of patients who accomplish the complete resection of tumor with pathologically confirmed negative margin |
| pCR rate | 24 months | Pathological complete regression (pCR) rate, defined as the proportion of patients with no evidence of vital residual tumor cells on the complete resected specimen. pCR status will be analyzed by local pathologists at each site |
| ORR | 24 months | Objective response rate (ORR) , defined as the proportion of patients with a complete response (CR) or partial response (PR), as determined by the investigator according to RECIST v1.1 and HCC mRECIST |
Countries
China
Contacts
CONTACTWei Dai, M.D, PhD
Outcome results
None listed