ThrombopeniaPhase 2NCT06745219
Herombopag for the Prevention of Radio-chemotherapy Induced Thrombocytopenia in Cervical Cancer
A Phase 2 study testing herombopag in people with Thrombopenia and Cervical Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
Exploring and evaluating the efficacy of herombopag in preventing thrombocytopenia due to radiotherapy for cervical cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Thrombopenia, Cervical Cancer, Radiotherapy Side Effect
- What is being tested?
- herombopag
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Jul 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
- Bone marrow invasion or metastasis
- 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
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- 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
- known or expected allergy or intolerance to the active ingredient or excipient of hetropopar ethanolamine tablets
- HIV infected
- Pregnant or lactating women
- Participated in clinical trials of any other investigational drug or device within 28 days
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Cancer Hospital
Beijing, Beijing Municipality, 1001042
Xiaofan Li, Dr, +8601088196991, lxflp@163.com
About this study
Official title: 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
Read the detailed description
Thrombocytopenia is a relatively common adverse effect for cancer treatment. At present, for the secondary prevention of thrombocytopenia associated with tumor therapy, TPO-RA drugs have been included in the Level III recommendation of the "Thrombocytopenia Diagnosis and Treatment Guidelines for Cancer Treatment (2022 Edition)".
Herombopag, a new generation of thrombopoietin receptor agonist, is a Class 1 innovative drug independently developed in China, which has been approved in June 2021 for the indication of chronic primary immune thrombocytopenia with poor response to previous treatments of glucocorticoids and immunoglobulins, as well as severe aplastic anemia with poor efficacy of immunosuppressive treatments. As an oral medication, this drug is more convenient and safer than traditional injectable preparations. However, this drug has not been formally approved for the treatment of therapy-related thrombocytopenia.
This study is planned to enroll cervical cancer patients with thrombocytopenia due to radiotherapy combined with a three-week regimen of chemotherapy, and to evaluate the efficacy of herombopag in preventing thrombocytopenia in this group of patients.
- Being tested
- herombopag
- Medical subject headings
- Thrombocytopenia, Uterine Cervical Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
herombopagDrug
Also called Platelet receptor agonists
receive harombopag for the prevention of thrombocytopenia in the next cycle of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Herombopag | Experimental | Cervical cancer patients who developed thrombopenia after receiving radiotherapy and platinum-based chemotherapy were enrolled Receives: Drug: herombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with PLT <75×109/L after the use of herombopag
number of participants with PLT <75×109/L/ all participants
Measured: Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy
Secondary outcomes (6)
minimum value of platelet after chemotherapy
minimum value of platelet of every participants after chemotherapy for every participants
Measured: Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy
Change from baseline in PLT count minimum value
absolute value change from the maximum or minimum of platelet to baseline for every participants
Measured: Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy
Median duration of PLT <75×109/L
the days during the PLT <75×109/L of every participants
Measured: Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy
Median time to recovery of PLT to ≥100×109/L
the days during the PLT >100×109/L of every participants
Measured: Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy
Platelet count one day before the next chemotherapy
Platelet count one day before the next chemotherapy of every participants
Measured: Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy
Incidence of reduced intensity of next cycle chemotherapy due to decreased PLT
number of reduced intensity/number of no reduced intensity for next cycle chemotherapy due to decreased PLT
Measured: Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for ThrombopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xiaofanli, Peking University Cancer Hospital & Institute
- Investigators
- Xiaofan Li, Dr, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745219
- Sponsor's protocol ID
- 2024YJZ53
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu 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.
PubMed 20110050Krigel 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.
PubMed 8201386Veldhuis 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.
PubMed 9043028Elias 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.
PubMed 2110385Kim 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.
PubMed 26187614Mkhitaryan 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.
PubMed 30915164Penniment MG, De Ieso PB, Harvey JA, Stephens S, Au HJ, O'Callaghan CJ, Kneebone A, Ngan SY, Ward IG, Roy R, Smith JG, Nijjar T, Biagi JJ, Mulroy LA, Wong R; TROG 03.01/CCTG ES.2 group. Palliative chemoradiotherapy versus radiotherapy alone for dysphagia in advanced oesophageal cancer: a multicentre randomised controlled trial (TROG 03.01). Lancet Gastroenterol Hepatol. 2018 Feb;3(2):114-124. doi: 10.1016/S2468-1253(17)30363-1. Epub 2017 Dec 14.
PubMed 29248399Weycker D, Hatfield M, Grossman A, Hanau A, Lonshteyn A, Sharma A, Chandler D. Risk and consequences of chemotherapy-induced thrombocytopenia in US clinical practice. BMC Cancer. 2019 Feb 14;19(1):151. doi: 10.1186/s12885-019-5354-5.
PubMed 30764783Denduluri N, Lyman GH, Wang Y, Morrow PK, Barron R, Patt D, Bhowmik D, Li X, Bhor M, Fox P, Dhanda R, Saravanan S, Jiao X, Garcia J, Crawford J. Chemotherapy Dose Intensity and Overall Survival Among Patients With Advanced Breast or Ovarian Cancer. Clin Breast Cancer. 2018 Oct;18(5):380-386. doi: 10.1016/j.clbc.2018.02.003. Epub 2018 Feb 16.
PubMed 29622384Gernsheimer T. Chronic idiopathic thrombocytopenic purpura: mechanisms of pathogenesis. Oncologist. 2009 Jan;14(1):12-21. doi: 10.1634/theoncologist.2008-0132. Epub 2009 Jan 14.
PubMed 19144680Xie C, Zhao H, Bao X, Fu H, Lou L. Pharmacological characterization of hetrombopag, a novel orally active human thrombopoietin receptor agonist. J Cell Mol Med. 2018 Nov;22(11):5367-5377. doi: 10.1111/jcmm.13809. Epub 2018 Aug 29.
PubMed 30156363Mei H, Liu X, Li Y, Zhou H, Feng Y, Gao G, Cheng P, Huang R, Yang L, Hu J, Hou M, Yao Y, Liu L, Wang Y, Wu D, Zhang L, Zheng C, Shen X, Hu Q, Liu J, Jin J, Luo J, Zeng Y, Gao S, Zhang X, Zhou X, Shi Q, Xia R, Xie X, Jiang Z, Gao L, Bai Y, Li Y, Xiong J, Li R, Zou J, Niu T, Yang R, Hu Y. A multicenter, randomized phase III trial of hetrombopag: a novel thrombopoietin receptor agonist for the treatment of immune thrombocytopenia. J Hematol Oncol. 2021 Feb 25;14(1):37. doi: 10.1186/s13045-021-01047-9.
PubMed 33632264