Clinical trial · Interventional
A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Targeted Therapy and a PD-1 Inhibitor in Patients With Postoperative Hepatocellular Carcinoma and Microvascular Invasion
NCT07790419CI-TRIAL-00124120not yet recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined with Targeted Therapy and a PD-1 Inhibitor in Patients with Postoperative Hepatocellular Carcinoma and Microvascular Invasion
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donafenib + lenvatinib+apatinib | Drug | — | UNRESOLVED |
| HAIC | Radiation | — | UNRESOLVED |
| Sintilimab+camrelizumab+tislelizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HAIC+Targeted Therapy +PD-1 Inhibitor
- description
- Hepatic arterial infusion chemotherapy (HAIC): to be performed within 4-8 weeks after liver cancer surgery, as follows: Oxaliplatin 65 mg/m², IA (intra-arterial), Day 1, 0-5 hours: 5-FU 1200 mg/m², IA, maintained for 23 hours. After catheter removal, a pressure dressing for hemostasis for 6-12 hours is sufficient before discharge. The above HAIC treatment will be repeated every 3-4 weeks for a total of 2 cycles. Targeted drugs: Including lenvatinib: oral administration according to body weight; body weight ≥60 kg, 8-12 mg QD; body weight \<60 kg, 4-8 mg QD; donafenib: 80 mg BID; apatinib: 250 mg QD. The above targeted drugs will be appropriately adjusted according to the patient's tolerance to toxic side effects. PD-1 inhibitors : sintilimab 200 mg Q3W, ivgtt; camrelizumab 200 mg Q3W, ivgtt; tislelizumab 200 mg Q3W, ivgtt. This study will follow participants for disease recurrence and disease-free survival for at least 2 years. After all participants complete treatment or the
- interventionNames
- Radiation: HAIC
- Drug: Donafenib + lenvatinib+apatinib
- Drug: Sintilimab+camrelizumab+tislelizumab
Primary outcomes (1)
- measure
- Disease-free survival (DFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-80 years, male or female; 2. Pathologically confirmed hepatocellular carcinoma, with complete resection of all tumor nodules and negative surgical margins; 3. Microvascular invasion (MVI) grade ≥ 1 4. No other history of tumors and no preoperative anticancer treatment. 5. ECOG: 0-1; 6. Baseline blood count tests and blood biochemistry must meet the following criteria: Hemoglobin ≥80 g/L; Absolute neutrophil count ≥1.5×109/L; Platelet count ≥50×109/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 times the upper limit of normal (ULN); Total bilirubin ≤3 times ULN; Serum creatinine ≤1.5 times ULN; Albumin ≥28 g/L; prothrombin time (PT) ≤19.5 s; International normalized ratio (INR) ≤2.3 7. Women of childbearing potential must agree to use contraception during the study and for 6 months after the study ends (e.g., intrauterine device, oral contraceptives, or condoms); serum or urine pregnancy test must be negative within 7 days before enrollment, and they must not be breastfeeding; men must agree to use contraception during the study and for 6 months after the study ends; 8. Subjects voluntarily participate in this study, sign the informed consent form, are compliant, and cooperate with follow-up. Exclusion Criteria: * 1\. Patients with any active autoimmune disease or a history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; patients whose childhood asthma has completely resolved and who require no intervention as adults may be included; asthma requiring bronchodilator intervention for medical management cannot be included); 2\. Pregnancy or lactation; 3\. Over 80 years old; 4\. Prior systemic chemotherapy or radiotherapy; 5\. Concomitant malignant pleural effusion or ascites; 6\. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation); 7\. Concomitant infection requiring anti-infective treatment; 8\. Concomitant peripheral nervous system disease or a history of significant psychiatric disease and central nervous system disease; 9\. Diagnosis of other types of malignant tumors within 5 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix; 10\. Uncorrectable coagulation disorders; 11\. Significant ECG abnormalities or obvious clinical symptoms of heart disease, such as congestive heart failure (CHF), clinically significant coronary heart disease, difficult-to-control arrhythmias, and hypertension; 12\. History of myocardial infarction within 12 months, or cardiac function class III or IV; 13\. Severe liver disease (e.g., cirrhosis), kidney disease, respiratory disease, uncontrolled diabetes, or other systemic diseases; 14\. Individuals deemed unsuitable for inclusion by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.