Skip to content

Multicenter, open label, randomized controlled study of 36000IU versus 40000IU EPO in the treatment of chemotherapy related anemia patients with solid tumors

Multicenter, open label, randomized controlled study of 36000IU versus 40000IU EPO in the treatment of chemotherapy related anemia patients with solid tumors

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067378
Enrollment
Unknown
Registered
2023-01-05
Start date
2023-01-09
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Chemotherapy related anemia in solid tumor

Interventions

Experimental group:EPO 36000IU
Control group:EPO 40000IU

Sponsors

Liaoning Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old, gender is not limited; 2. ECOG score 0-2 points; 3. Solid malignant tumors receive chemotherapy, the expected survival time is more than 3 months, and plan to receive 2 or more cycles of treatment; 4. Previously received less than or equal to second-line chemotherapy in the advanced stage, if the recurrence occurs within 6 months after the completion of adjuvant therapy, it is defined as advanced first-line chemotherapy; 5. Chemotherapy-related anemia is defined as no anemia exists before chemotherapy, and Hb is greater than 60 g/L and less than or equal to 100 g/L after chemotherapy; 6. Liver function total bilirubin = 1.5*10^9 /L, platelets >= 90*10^9 /L; 7. Meet the admission criteria for chemotherapy; 8. Voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Other anemia diseases (such as aplastic anemia, myelodysplastic syndrome, thalassemia, etc.); 2. Chemotherapy combined with other drugs known to affect bone marrow erythroid hematopoietic function; 3. Plan to change the chemotherapy regimen during the application of EPO; 4. Thrombosis or cardiovascular and cerebrovascular accidents occurred in the past 6 months; 5. Unstable brain metastases (symptoms within 4 weeks need emergency intracranial pressure lowering treatment or imaging suggests that the disease is progressing, if the patient has the first onset, asymptomatic brain metastases and it is determined that no immediate brain radiotherapy is required), there is Mentally disabled or incapacitated patients; 6. Erythropoietin treatment within the first 4 weeks; 7. Patients who have participated in other clinical trials within 4 weeks; 8. Patients who received radiotherapy within 4 weeks; the cumulative range of previous radiotherapy for weight-bearing bones was >= 30%; 9. History of blood transfusion in the past 14 days; 10. Female patients who are pregnant or breastfeeding, patients who are fertile and have a positive baseline pregnancy test, or those of childbearing age who are unwilling to take effective contraceptive measures during the entire test period; 11. Any other circumstances that the investigator believes that the patient is not suitable for participating in this study; 12. Patients with contraindications of EPIAO: (1) Uncontrolled severe hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg); (2) Those who are allergic to this product and other mammalian cell derivatives, or those who are allergic to human serum albumin; (3) For patients with co-infection, it is advisable to control the infection before using this product.

Design outcomes

Primary

MeasureTime frame
hemoglobin;

Countries

China

Contacts

Public ContactTao Sun

Liaoning Cancer Hospital

lnzlrxnsy@163.com+86 139 4040 4526

Outcome results

None listed

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