A single arm, prospective, and exploratory study of apatinib combined with Camrelizumab, HAIC, and SBRT in the treatment of liver cancer with portal vein tumor thrombus

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300078562

Enrollment

Unknown

Registered

2023-12-12

Start date

2023-12-15

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma

Interventions

experimental group:Apatinib combined with Camrelizumab, HAIC, and SBRT

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Hepatocellular carcinoma patients aged 18-80 with a pre survival period exceeding 12 weeks; 2. Subjects diagnosed with HCC through histopathology or clinically diagnosed with HCC according to the "Diagnosis and Treatment Guidelines for Primary Liver Cancer (2022 Edition)"; 3. CNLC staging: Stage IIIA or IIIB (BCLC-C stage); 4. Patients diagnosed by imaging with portal vein cancer thrombus; 5. Child-Pugh liver function rating: A or B (= 7 points) 6. ECOG PS score: 0-1 points; 7. Has not received systematic or local interventional therapy for hepatocellular carcinoma in the past (including TACE, HAIC, etc.); 8. At least one measurable lesion (according to RECIST v1.1); 9. The main organs function normally and meet the following standards: (1) Blood routine examination: (a) Hemoglobin (HB) = 90 g/L; (b) White blood cells (ANC) = 3.0 × 10 ^ 9/L; (c) Neutrophils = 1.5 × 10 ^ 9/L; (d) Platelet (PLT) = 75 × 10 ^ 9/L; (2) Biochemical examination: (a) Albumin (ALB) = 29 g/L; (b) ALT and AST<5ULN; Total bilirubin (TBIL) = 1.5 ULN; Creatinine = 1.5ULN; 10. Patients and/or family members agree to participate in clinical trials and sign informed consent forms

Exclusion criteria

Exclusion criteria: 1. Patients preparing for liver transplantation; 2. Patients with severe interstitial pneumonia or active pulmonary tuberculosis. 3. Patients with severe abnormal lung function; 4. Patients with autoimmune diseases; 5. Suffering from grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval = 450 ms for males and = 470 ms for females); 6. Severe abnormalities in coagulation function that cannot be corrected; 7. Patients who are allergic to any component of apatinib; 8. Patients with active bleeding within the past 3 months; 9. Patients with gastrointestinal ulcers, intestinal perforation, or intestinal obstruction; 10. Patients within 30 days after major surgery; 11. Patients with hypertension still have poor blood pressure control after treatment with antihypertensive drugs (systolic blood pressure>160 mmHg, diastolic blood pressure>100 mmHg); 12. Urinary routine examination shows urine protein =++or confirms 24-hour urine protein quantification>1.0g; 13. Pregnant or lactating female patients; 14. Have a history of mental illness or abuse of psychotropic substances; 15. Patients and/or family members do not agree to participate in clinical trials.

Design outcomes

Primary

Measure	Time frame
progression-free survival,PFS;	—

Secondary

Measure	Time frame
Overall Survival,OS;Objective response rate,ORR;DCR;	—

Countries

China

Contacts

Public ContactKan xuefeng

Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital

xkliulang1314@163.com+86 135 4587 4189

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026