Herombopag for the Prevention of Radio-chemotherapy Induced Thrombocytopenia in Cervical Cancer

NCT06745219 | Not Yet Recruiting Phase 2

• 1 other identifier: 2024YJZ53
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thrombopenia; Cervical Cancer; Radiotherapy Side Effect; Chemotherapeutic Toxicity

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with PLT <75×109/L after the use of herombopag

  number of participants with PLT \<75×109/L/ all participants

  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

  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

  Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy

• Median duration of PLT <75×109/L

  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

  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

  Blood routine tests were conducted every three days within 14 days after the first day of chemotherapy

Study Arms (1)

Herombopag

EXPERIMENTAL

Cervical cancer patients who developed thrombopenia after receiving radiotherapy and platinum-based chemotherapy were enrolled

Drug: herombopag

Interventions

herombopag DRUG

receive harombopag for the prevention of thrombocytopenia in the next cycle of chemotherapy

Also known as: Platelet receptor agonists

Herombopag

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 1001042, China

Location

Related Publications (12)

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MeSH Terms

Conditions

Thrombocytopenia; Uterine Cervical Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Wounds and Injuries

Study Officials

• Xiaofan Li, Dr

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaofan Li, Dr

CONTACT

+8601088196991; lxflp@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: January 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 30, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)