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A prospective, single-arm, single-center, open clinical study of Carrilizumab combined with apatinib mesylate or first-line chemotherapy in the treatment of advanced liver cancer

A prospective, single-arm, single-center, open clinical study of Carrilizumab combined with apatinib mesylate or first-line chemotherapy in the treatment of advanced liver cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041446
Enrollment
Unknown
Registered
2020-12-26
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-15

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:First-line treatment

Sponsors

The Second Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18-75 years old, including 18-75 years old (calculated from the date of signing informed consent), both men and women; 2. Subjects with hepatocellular carcinoma confirmed by histopathology, cytology and imaging; 3. Subjects with BCLC stage B or C; 4. Subjects with child Pugh score = 1.5 x 10^9 / L, PLT >= 50 x 10^9 / L, Hgb >= 9.0 g / dl; (2) Renal function: Cr <= 1.5 x ULN, urinary protein < 2 +; 8. Subjects with an estimated survival time of 12 weeks or more; 9. The subjects who volunteered to join the study signed the informed consent with good compliance and cooperated with the follow-up; 10. Researchers believe that treatment can benefit.

Exclusion criteria

Exclusion criteria: 1. Patients who have been proved to be allergic to the test drug and its excipients; 2. Patients with history of hepatic encephalopathy or liver transplantation; 3. Patients with severe bleeding tendency or coagulation dysfunction; 4. Subjects who had bleeding events of esophageal or gastric varices caused by portal hypertension in the past 6 months, or had any life-threatening bleeding events in the past 3 months; 5. Patients with cardiac clinical symptoms or diseases that can not be well controlled, such as: (1) heart failure of NYHA grade 2 or above; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; 6. Patients with history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of lung function; 7. In patients with acute or chronic active hepatitis B or hepatitis C infection, viral DNA > 2000 IU / ml and HCV RNA > 103 copies / ml; 8. Patients with hypertension who can not be well controlled by antihypertensive drugs (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg); 9. Pregnant or lactating women; 10. According to the judgment of the researcher, it is not suitable for patients to be included in this study.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
OS;AE;

Countries

China

Contacts

Public ContactWu Chunli

The Second Affiliated Hospital of Anhui Medical University

wchl1234567@126.com+86 13965130600

Outcome results

None listed

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