A randomized controlled study of single-dose pharmacokinetics of toripalimab injection in hepatic arterial infusion versus intravenous infusion in malignant melanoma liver metastases

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100054307

Enrollment

Unknown

Registered

2021-12-13

Start date

2021-12-13

Completion date

Unknown

Last updated

2022-11-14

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

Conditions

malignant melanoma

Interventions

Experimental group:perfusion toripalimab injection

Control group:infusion of toripalimab intravenously

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. Pathologically confirmed melanoma (including skin and mucosal melanoma and choroidal melanoma); 3. Diffuse liver metastases in the liver (number of tumors > 5), of which the diameter of the largest metastases is 2.8g/L, total bilirubin=60 x 10^9/L, prothrombin time prolongation <6s; 10. No history of autoimmune diseases; 11. Patients who signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Have autoimmune disease; 2. Have a history of organ transplantation in the past; 3. Patients with portal aneurysm thrombus; 4. Patients with severe blood reflux disorder 5. Obvious renal and endocrine dysfunction; 6. Associated with other malignant tumors; 7. Children and pregnant patients.

Design outcomes

Primary

Measure	Time frame
venous blood concentration;	—

Countries

China

Contacts

Public ContactFan Weijun

Sun Yat-Sen University Cancer Center

fanwj@sysucc.org.cn+86 13826154530

Outcome results

None listed

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