Herombopag to Prevent Low Platelets During Cervical Cancer Radiotherapy
Tests herombopag to prevent low platelet counts in adults with cervical cancer receiving radiation.
Plain-language title generated from the registry record
Registry title: Herombopag for the Prevention of Radio-chemotherapy Induced Thrombocytopenia in Cervical Cancer
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with cervical cancer who are getting cisplatin-based chemotherapy with radiotherapy and have had low platelet counts, to test herombopag in preventing this.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Cervical cancer confirmed by tests, FIGO 2018 stage IB3 to IVA, ECOG performance score 0-1
- Earlier treatment
- Must be getting cisplatin-based two-drug chemotherapy every three weeks. At the last chemotherapy the lowest platelet count was below 50×109/L, or from 50 to below 75×109/L with at least one high bleeding risk factor. Expected to live at least 12 weeks.
Main reasons for not taking part
- Other blood or bone marrow diseases, or bone marrow invasion or metastasis
- Low platelets in the last 6 months from other causes
- Serious heart disease or any blood clot in the last 6 months
- Severe bleeding within 2 weeks
- HIV infection, or being pregnant or breastfeeding
Read by machine on 9 November 2026.
Where in China
- Peking University Cancer HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking University Cancer Hospital & Institute
- Trial code
- NCT06745219
- Record updated
- 20 December 2024
- Original description
Exploring and evaluating the efficacy of herombopag in preventing thrombocytopenia due to radiotherapy for cervical cancerRead full original descriptionShow less
Herombopag for the Prevention of Radio-chemotherapy Induced Thrombocytopenia in Cervical Cancer: A Single-arm Phase II Clinical Trial
Exploring and evaluating the efficacy of herombopag in preventing thrombocytopenia due to radiotherapy for cervical cancer
Inclusion: Volunteer to participate in the trial and sign the informed consent; Pathologically or cytologically confirmed cervical cancer; aged 18 years or older; ECOG performance score 0-1; Stage IB3-IVA according to 2018 FIGO stage; Patients receiving cisplatin-contained two-drug every-three week chemotherapy; minimum PLT value of the last chemotherapy <50×109/L, or ≥50 ×109/L, but <75×109/L, meeting at least one high risk factor for bleeding: previous bleeding history; receiving cisplatin, gemcitabine, cytarabiine, anthracycline chemotherapy; combination of targeting or chemotherapy drugs likely to cause thrombocytopenia; tumor bone marrow infiltration; receiving radiotherapy, such as long bone or flat bone (pelvic or sternum); Survival expected to be ≥12 weeks, and can be treated with the concurrent chemotherapy regimen for at least one cycle; Participants of reproductive age who agree to use reliable contraceptive methods throughout the study period (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive film, contraceptive paste, contraceptive suppository, abstinence from sex, and insertion of an IUD); Female subjects who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation or more than 1 year postmenopausal and male subjects who have undergone bilateral vasectomy or ligation are excluded; Participants can be treated with thrombopoietic drugs determined by researchers.
Exclusion: Participated in clinical trials of any other investigational drug or device within 28 days; Participants with other diseases of hematopoietic system, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome; Participants with thrombocytopenia occurred within the last 6 months due to causes other than CTIT, including but not limited to chronic liver disease, hypersplenism, infection; History of severe cardiovascular disease within the last 6 months, such as congestive heart failure (NYHA heart function score III-IV), arrhythmias known to increase the risk of thromboembolism such as atrial fibrillation, after coronary stenting, angioplasty, and para-coronary transplantation, etc; History of any arterial or venous thrombosis within the last 6 months; Severe bleeding within 2 weeks, such as gastrointestinal or central nervous system bleeding, vaginal bleeding, etc; known or expected allergy or intolerance to the active ingredient or excipient of hetropopar ethanolamine tablets; HIV infected; Inability to swallow, inflammatory bowel disease, or uncontrollable nausea, vomiting, diarrhea, or other gastrointestinal disorders that severely affect the administration and absorption of medications; With a high risk for participants' safety or other conditions that may affect the efficacy evaluated by investigators; Neutrophil absolute value <1.5×109/L, hemoglobin <80g/L, PLT<90× 109/L; Significantly abnormal liver function :TBIL>1.5ULN(upper limit of normal), >3ULN for patients known to have Gilbert syndrome; ALT>2.5ULN or AST>2.5ULN; Abnormal renal function: serum creatinine ≥1.5ULN or eGFR≤60 ml/min(Cockcroft-Gault formula); Had received platelet infusion within 3 days; Bone marrow invasion or metastasis; Pregnant or lactating women.