Clinical trial · Interventional
Herombopag for the Prevention of Radio-chemotherapy Induced Thrombocytopenia in Cervical Cancer
Herombopag for the Prevention of Radio-chemotherapy Induced Thrombocytopenia in Cervical Cancer: A Single-arm Phase II Clinical Trial
NCT06745219CI-TRIAL-00083961not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Exploring and evaluating the efficacy of herombopag in preventing thrombocytopenia due to radiotherapy for cervical cancer
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
| Thrombopenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| herombopag | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Herombopag
- description
- Cervical cancer patients who developed thrombopenia after receiving radiotherapy and platinum-based chemotherapy were enrolled
- interventionNames
- Drug: herombopag
Primary outcomes (1)
- measure
- Proportion of participants with PLT <75×109/L after the use of herombopag
- timeFrame
- Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy
- description
- number of participants with PLT \<75×109/L/ all participants
Secondary outcomes (6)
- measure
- minimum value of platelet after chemotherapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Volunteer to participate in the trial and sign the informed consent 2. Pathologically or cytologically confirmed cervical cancer 3. aged 18 years or older 4. ECOG performance score 0-1 5. Stage IB3-IVA according to 2018 FIGO stage 6. 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) 7. Survival expected to be ≥12 weeks, and can be treated with the concurrent chemotherapy regimen for at least one cycle 8. 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 9. Participants can be treated with thrombopoietic drugs determined by researchers Exclusion Criteria: 1. Participants with other diseases of hematopoietic system, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome 2. 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 3. Bone marrow invasion or metastasis 4. 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 5. History of any arterial or venous thrombosis within the last 6 months 6. Severe bleeding within 2 weeks, such as gastrointestinal or central nervous system bleeding, vaginal bleeding, etc 7. Neutrophil absolute value \<1.5×109/L, hemoglobin \<80g/L, PLT\<90× 109/L 8. 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 9. Abnormal renal function: serum creatinine ≥1.5ULN or eGFR≤60 ml/min(Cockcroft-Gault formula) 10. Had received platelet infusion within 3 days 11. known or expected allergy or intolerance to the active ingredient or excipient of hetropopar ethanolamine tablets 12. HIV infected 13. Pregnant or lactating women 14. Participated in clinical trials of any other investigational drug or device within 28 days 15. Inability to swallow, inflammatory bowel disease, or uncontrollable nausea, vomiting, diarrhea, or other gastrointestinal disorders that severely affect the administration and absorption of medications 16. With a high risk for participants' safety or other conditions that may affect the efficacy evaluated by investigators
References
Publications (12)
- RESULTWu Y, Aravind S, Ranganathan G, Martin A, Nalysnyk L. Anemia and thrombocytopenia in patients undergoing chemotherapy for solid tumors: a descriptive study of a large outpatient oncology practice database, 2000-2007. Clin Ther. 2009;31 Pt 2:2416-32. doi: 10.1016/j.clinthera.2009.11.020. PMID 20110050
- RESULTKrigel RL, Palackdharry CS, Padavic K, Haas N, Kilpatrick D, Langer C, Comis R. Ifosfamide, carboplatin, and etoposide plus granulocyte-macrophage colony-stimulating factor: a phase I study with apparent activity in non-small-cell lung cancer. J Clin Oncol. 1994 Jun;12(6):1251-8. doi: 10.1200/JCO.1994.12.6.1251. PMID 8201386
- RESULTVeldhuis GJ, Willemse PH, Beijnen JH, Boonstra H, Piersma H, van der Graaf WT, de Vries EG. Paclitaxel, ifosfamide and cisplatin with granulocyte colony-stimulating factor or recombinant human interleukin 3 and granulocyte colony-stimulating factor in ovarian cancer: a feasibility study. Br J Cancer. 1997;75(5):703-9. doi: 10.1038/bjc.1997.125. PMID 9043028
- RESULTElias A, Ryan L, Aisner J, Antman KH. Mesna, doxorubicin, ifosfamide, dacarbazine (MAID) regimen for adults with advanced sarcoma. Semin Oncol. 1990 Apr;17(2 Suppl 4):41-9. PMID 2110385
- RESULTKim G, Ison G, McKee AE, Zhang H, Tang S, Gwise T, Sridhara R, Lee E, Tzou A, Philip R, Chiu HJ, Ricks TK, Palmby T, Russell AM, Ladouceur G, Pfuma E, Li H, Zhao L, Liu Q, Venugopal R, Ibrahim A, Pazdur R. FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy. Clin Cancer Res. 2015 Oct 1;21(19):4257-61. doi: 10.1158/1078-0432.CCR-15-0887. Epub 2015 Jul 17. PMID 26187614
- RESULTMkhitaryan S, Danielyan S, Sargsyan L, Hakobyan L, Iskanyan S, Bardakchyan S, Papyan R, Arakelyan J, Sahakyan K, Avagyan T, Tananyan A, Muradyan A, Tamamyan G. Younger age and previous exposure to radiation therapy are correlated with the severity of chemotherapy-induced thrombocytopenia. Ecancermedicalscience. 2019 Feb 26;13:906. doi: 10.3332/ecancer.2019.906. eCollection 2019.