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A Randomized Controlled Phase II Clinical Trial of Recombinant Human Thrombopoietin in Prevention of Thrombocytopenia in Concurrent Chemoradiotherapy for Cervical Cancer

A Randomized Controlled Phase II Clinical Trial of Recombinant Human Thrombopoietin in Prevention of Thrombocytopenia in Concurrent Chemoradiotherapy for Cervical Cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017093
Enrollment
Unknown
Registered
2018-07-12
Start date
2018-07-31
Completion date
Unknown
Last updated
2018-07-16

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

Conditions

cervical cancer

Interventions

treatment group:Preventative use of rhTPO
Control Group:No prevention use of rhTPO

Sponsors

Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Pathological histology and cytology were diagnosed as cervical carcinoma; 2. Clinical stages were IB2, IIA2, IIB, IIIA, IVA, and patients with concurrent chemoradiotherapy; IB1 and IIA1, which are not suitable for surgery or refused surgery, are patients with concurrent chemoradiotherapy. 3. Older than 18 years; 4. PS score is 0-1 (ECOG); 5. Adequate bone marrow function: peripheral blood leukocyte >4.0*10^9/L, neutrophils >2.0*10^9/L, hemoglobin >90g/L, platelet >100*10^9/L; 6. Normal liver and kidney function: AST, ALT<2.5 times normal value upper limit, total bilirubin <1.5 times normal value upper limit; Serum creatinine value < normal value upper limit; 7. Be able to understand and accept the research proposal and sign the informed consent prior to the commencement of the specific drafting process.

Exclusion criteria

Exclusion criteria: 1. Received other anti-tumor treatment before concurrent chemoradiotherapy, including radical surgery, palliative reduction surgery, prior to chemoradiotherapy or intravenous chemotherapy; 2. Having a history of hematopoiesis (with the exception of patients with anaemia, who do not need long-term treatment and >90g/L) or other diseases that affect the blood clotting/platelet count or platelet function; 3. Because of underlying diseases, aspirin or other anticoagulant/anti-platelet aggregation drugs must be used for a long time; 4. Combine other tumors; 5. There are other serious diseases requiring immediate treatment, such as severe cardiopulmonary dysfunction/acute infection (>2 nci-ctc V3.0); 6. Pregnant or breast-feeding patients who are pregnant may have to check the pregnancy results within 7 days of the treatment to continue; Patients enrolled in the trial (both men and women) must take contraceptive measures two weeks after completion of the trial; 7. PS score is greater than or equal to 2; 8. The patient refuses to participate, or has personality or mental disorders, or has no capacity for civil conduct or limited capacity for civil conduct.

Design outcomes

Primary

MeasureTime frame
thrombocyte;

Countries

China

Contacts

Public ContactJin-Quan Liu

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

609149209@qq.com+86 13710866485

Outcome results

None listed

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