Sequential sorafenib and PD-1 therapy and tumor gene characteristics after resection of MVI positive hepatocellular carcinoma

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200055725

Enrollment

Unknown

Registered

2022-01-16

Start date

2022-01-10

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

liver cancer

Interventions

Test group 1:Sequential sorafenib

Test group 2:Sequential PD-1 antibody

Test group 3:Sequential sorafenib and PD-1 antibody

control group:No above sequential treatment

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 75 years; 2. The preoperative BCLC stage of liver cancer was A-C, but no tumor thrombi was found in portal vein (including branches), hepatic vein (including branches) or vena cava by imaging examination such as color ultrasound, CT or MRI; 3. After hepatectomy, pathological examination confirmed the diagnosis of hepatocellular carcinoma, with negative resection margin but positive MVI; 4. Patients with hypertension and diabetes have stable control of blood pressure and blood glucose; 5. No immune diseases, no immunosuppressive agents, normal immune function; 6. Of normal mental capacity and spirit; 7. Patients who are willing to participate in the study and can understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating patients. 2. During treatment, blood pressure fluctuated greatly and could not be restored to stability by drug control; 3. Patients with hypertensive heart disease, hypertensive encephalopathy or hypertensive nephropathy; 4. Patients who could not tolerate sorafenib and PD-1 antibody treatment; 5. Patients with severe mental illness or mental disorder; 6. Suffering from other diseases that the research team believes may affect the smooth conduct of the study or may cause obvious bias in the results of the study, or other reasons that the research team considers inappropriate to participate in the study; 7. Serious diseases of the heart, lungs, brain, kidneys and other organ systems.

Design outcomes

Primary

Measure	Time frame
Progress-free survival, PFS;Overall survival, OS;	—

Countries

China

Contacts

Public ContactChen Shengkai

Chongqing General Hospital

chenskthomas@163.com+86 15923961892

Outcome results

None listed

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