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An observational study of the efficacy and safety of pD-1 immune checkpoint inhibitors combined with tyrosine kinase inhibitors in patients with primary hepatocellular carcinoma with decompensated cirrhosis

An observational study of the efficacy and safety of pD-1 immune checkpoint inhibitors combined with tyrosine kinase inhibitors in patients with primary hepatocellular carcinoma with decompensated cirrhosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200056227
Enrollment
Unknown
Registered
2022-02-01
Start date
2020-03-01
Completion date
Unknown
Last updated
2024-08-26

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

Conditions

Liver Cancer

Interventions

Group of HCC:PD-1 antibodies combined with tyrosine kinase inhibitors
Group of BTC:PD-1 antibodies combined with tyrosine kinase inhibitors

Sponsors

The Fifth Medical Center of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. Advanced liver cancer confirmed by histology/imaging; 3. BCLC stage B or C; 4. Child-Pugh score 5-10; 5. >= 1 measurable target lesion (according to mRECIST); 6. ECOG PS 0-1; 7. Life expectancy > 12 weeks; 8. Organ function is good.

Exclusion criteria

Exclusion criteria: 1. Concomitant with other primary malignant tumors; 2. Severe coagulation dysfunction or severe thrombocytopenic purpura; 3. Complicated with severe cardiac and renal insufficiency, poorly controlled diabetes, hypertension and other diseases.

Design outcomes

Primary

MeasureTime frame
the occurrence of adverse events;objective response rate;—

Countries

China

Contacts

Public ContactFanping Meng

The Fifth Medical Center of Chinese PLA General Hospital

drmengfanping@126.com+86 13581797836

Outcome results

None listed

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