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Prospective, open, randomized controlled study evaluated the efficacy and safety of jinyou for concurrent chemorheotherapy in patients with head and neck cancer /lung cancer /esophageal cancer

Prospective, open, randomized controlled study evaluated the efficacy and safety of jinyou for concurrent chemorheotherapy in patients with head and neck cancer /lung cancer /esophageal cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026886
Enrollment
Unknown
Registered
2019-10-25
Start date
2019-11-15
Completion date
Unknown
Last updated
2019-10-28

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

Conditions

neck cancer/lung cancer/esophageal cancer

Interventions

Experimental group:Subcutaneous injection was performed 48 hours after the end of chemotherapy
The control group:rhG-CSF was used with ANC<1.0×10^9/L during chemotherapy

Sponsors

Shandong Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years and = 20%, or 10% =1.5 x 10^9 /L, platelet count >= 80 x 10^9 /L, Hb >= 90 g/L, and no bleeding tendency; 7. The patient needs to sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. The patient currently has an uncontrolled infection, or has received systemic antibiotics within 72 hours of receiving chemotherapy; 2. Any patient with abnormal bone marrow hyperplasia and other hematopoietic dysfunction; 3. Patients who have received bone marrow or hematopoietic stem cell transplantation in the past 3 months; 4. Patients with previous malignant tumors that have not been cured or have brain metastases; 5. Liver function tests found that total bilirubin (TBIL), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) were >2.5 times the upper limit of normal; 6. Renal function tests found that serum creatinine (Cr) was >1.5 times the upper limit of normal; 7. Patients who are allergic to this product or other genetically engineered E. coli-derived biological products; 8. The patient who has a mental or neurological disorder and cannot cooperate; 9. Researchers believe patients are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Incidence of grade III /IV neutropenia in each cycle of chemotherapy;

Secondary

MeasureTime frame
Incidence of febrile neutropenia (FN) in each cycle of chemotherapy;Dose adjustment ratio of chemotherapeutic drugs and radiotherapy caused by neutropenia during each chemotherapy cycle;Incidence of treatment interruption by cycle (including chemotherapy and radiotherapy);Incidence and duration of grade III or above oral mucositis in each cycle;

Countries

China

Contacts

Public ContactBaosheng Li

Shandong Cancer Hospital

baoshli1963@163.com+86 18615193697

Outcome results

None listed

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