A phase I, single-center, one-arm and exploratory clinical study that hepatic artery perfusion of the new type of T cells activated by PD-1 combining with intravenous injection of PD-1 monoclonal antibody for hepatocellular carcinoma or metastatic liver cancer that had failed standard&

A phase I, single-center, one-arm and exploratory clinical study that hepatic artery perfusion of the new type of T cells activated by PD-1 combining with PD-1 monoclonal antibody intravenous injection for hepatocellular carcinoma or metastatic liver cancer that had failed standard&

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000036457

Enrollment

Unknown

Registered

2020-08-23

Start date

2020-08-31

Completion date

Unknown

Last updated

2020-09-14

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

Conditions

Liver Cancer

Interventions

Case series:new type of T cells activated by PD-1 combining with PD-1 monoclonal antibody intravenous injection

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. aged 18 to 75 years old; 2. Hepatocellular carcinoma patients with failed therapies,as PD-1 monoclonal antibody,chemotherapy et al.; 3. Life expectancy of 3 months or greater; 4. Eastern Cooperative Oncology Group (ECOG) performance status at 0-2; 5. Adequate venous access for blood collection; 6. WBC>=2.5x10^9/L, PLT>=60x10^9/L, Hb>=9.0g/dL, the count of lymphocyte subsets >=18%; 7. Albumin>=30g/L; 8. Serum lipase and amylase <1.5 ULN; 9. Serum certinine <1.5 ULN; 10. ALT<=5 ULN,AST<=5 ULN, LDH<=2 ULN; 11. Total serum bilirubin <=1.5 ULN; 12. PT<16s; INR<1.51 ULN; 13. Able to provide written, signed informed consent by patients or legal representative.

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant or breast-feeding; 2. Patients with HIV or other Immunodeficiency disease; 3. Uncontrollable active infection, including the level of HBV DNA >=1x10^3 copies/mL; 4. Systemic use of steroids is currently under way,but excluding patients with absorbed topical steroids; 5. Allergic to immunotherapy and related drugs; 6. Past or present presence of hepatic encephalopathy; 7. Participants have moderate or severe pleural effusion, pericardial effusion, and ascites; 8. Participants have heart condition that requires treatment or high blood pressure that poorly controlled; 9. Severe medical disease,and intervention and other related treatment intolerance; 10. Patients with unstable or active ulcers, gastrointestinal bleeding, or blood transfusion therapy within two months; 11. Patients with tumor metastases from the central nervous system or other tumors; 12. Patients who have received stem cell transplantation, a history of organ transplantation, or are awaiting organ transplantation; 13. Hyponatremia,serum sodium 300mg/day,clopidogrel dose>75mg/day; 17. Patients underwent chemoradiotherapy,local treatment and targeted antitumor drugs,or receive G-CSF (colony stimulating factor), interleukin and other cytokines therapy within 2 weeks prior to study initiation (blood collection); 18. Participated in other clinical trials within 1 month; 19. Unable or unwilling to provide informed consent or comply with research requirements; 20. Patients determined to be unsuitable for this study.

Design outcomes

Primary

Measure	Time frame
safety and tolerability;	—

Countries

China

Contacts

Public ContactYuhong Zhou/Zhiming Wang

Zhongshan Hospital, Fudan University

zhou.yuhong@zs-hospital.sh.cn+86 021-52303355

Outcome results

None listed

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