Clinical trial NCT06745219: Herombopag for the Prevention of Radio-chemotherapy Induced Thrombocytopenia in Cervical Cancer
Official title: Herombopag for the Prevention of Radio-chemotherapy Induced Thrombocytopenia in Cervical Cancer: A Single-arm Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Thrombopenia
Cervical Cancer
Radiotherapy Side Effect
Chemotherapeutic Toxicity
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Exploring and evaluating the efficacy of herombopag in preventing thrombocytopenia due to radiotherapy for cervical cancer

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.

Eligibility criteria: 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

Primary outcomes:
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
Secondary outcomes:
measure: minimum value of platelet after chemotherapy
timeFrame: Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy
measure: Change from baseline in PLT count minimum value
timeFrame: Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy
measure: Median duration of PLT <75×109/L
timeFrame: Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy
measure: Median time to recovery of PLT to ≥100×109/L
timeFrame: Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy
measure: Platelet count one day before the next chemotherapy
timeFrame: Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy
measure: Incidence of reduced intensity of next cycle chemotherapy due to decreased PLT
timeFrame: Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Xiaofan Li, Dr
role: PRINCIPAL_INVESTIGATOR
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