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A Study on the Feasibility of Using Serum Prothrombin Levels to Evaluate the Early Efficacy of Immunotherapy in Primary Hepatocellular Carcinoma

A Study on the Feasibility of Using Serum Prothrombin Levels to Evaluate the Early Efficacy of Immunotherapy in Primary Hepatocellular Carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108435
Enrollment
Unknown
Registered
2025-08-29
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Unresectable or metastatic primary liver cancer

Interventions

Observation group:None

Sponsors

The Eighth People‘s Hospital of Jinan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients with unresectable or metastatic HCC who meet the diagnostic criteria in the 2024 edition of the "Diagnostic Standards for Primary Hepatocellular Carcinoma" and have been confirmed through serum AFP, pathology, or imaging examinations; 2.BCLC B/C, liver function Child-Pugh A grade or better B grade. 3. Age >= 18 years, life expectancy of more than 3 months; 4.ECOG score of 0-1; 5.There should be evaluable lesions, and the evaluation criteria should be in line with the iRECIST standards. 6.The patient has not previously received any systemic anti-cancer treatments for advanced diseases.

Exclusion criteria

Exclusion criteria: 1. Those with an expected survival period of less than 3 months; 2. Patients with concomitant endocrine system disorders; 3. Patients with secondary liver cancer and other malignant tumors, severe cirrhosis, portal hypertension, ascites, Child-Pugh C liver function, coagulation dysfunction, severe cardiovascular and respiratory diseases; 4. Individuals with severe mental or psychological conditions who are unable to cooperate with treatment.

Design outcomes

Primary

MeasureTime frame
The abnormal change rate of prothrombin and the change rate of the maximum diameter of the tumor after 8 weeks of treatment;

Countries

China

Contacts

Public ContactZhu Tingting

The Eighth People‘s Hospital of Jinan

sdtaztt@163.com+86 531 76825361

Outcome results

None listed

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