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Effect of pegylated recombinant human granulocyte colony stimulating factor on immunotherapy of patients with liver cancer

Effect of pegylated recombinant human granulocyte colony stimulating factor on immunotherapy of patients with liver cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063207
Enrollment
Unknown
Registered
2022-09-01
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

liver cancer

Interventions

experimental group:Camrelizumab 200mg d1/q21, Apatin 250mg po qd, PEG-rhG-CSF 6mg q21
control group:Placebo subcutaneous injection

Sponsors

Department of Oncology, the Eighth People's Hospital of Jinan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. Histologically confirmed diagnosis of unresectable or metastatic HCC; 3. Completed CPS score detection, who are classified as below stage IIIB of chinalivercancerstaging (CNLC), who are treated or progressing or are not resistant to first-line targeted therapy; 4. According to the imRECIST standard, there is at least one diameter line that can be accurately measured; 5. The performance status of the eastern cancer cooperation group (ECOG) is 0 or 1; 6. Expected life is more than 12 weeks; 7. Child-Pugh A/B.

Exclusion criteria

Exclusion criteria: 1. Patients with cholangiocarcinoma, sarcomatoid liver cancer, mixed cell carcinoma, fibrous lamellar cell carcinoma, or other cancers for 5 years; 2. Patients with moderate or severe ascites and clinical symptoms (i.e. patients requiring therapeutic puncture and drainage), or uncontrolled pleural effusion or pericardial effusion; 3. Patients previously treated with PD-1 or PD-L1 inhibitors or apatinib; 4. Patients with severe gastrointestinal bleeding, gastrointestinal perforation or intestinal obstruction or unable to swallow within 6 months before enrollment; 5. Patients with severe infection; 6. Patients with a history of embolism, cerebral infarction or pulmonary infarction; 7. Patients with uncontrolled or unstable angina pectoris, uncontrolled hypertension, arrhythmia, cardiac insufficiency, congestive heart failure, or myocardial infarction less than 6 months after treatment; 8. Patients with interstitial pneumonia, interstitial lung disease, autoimmune diseases, congenital or acquired immunodeficiency; 9. Have a history of severe drug allergy to single drug or targeted therapy; 10. A woman who is pregnant or planning to become pregnant, or a man whose partner is considering becoming pregnant.

Design outcomes

Primary

MeasureTime frame
Overall Survival;

Countries

China

Contacts

Public ContactZhang Weike

The Eighth People's Hospital of Jinan

dapentidehama@outlook.com+86 13506340918

Outcome results

None listed

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