Not Yet RecruitingPhase 2

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

China30 participantsStarted 2025-01-01

Plain-language summary

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

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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 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

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

NCT IDNCT06745219

SponsorPeking University Cancer Hospital & Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

Xiaofan Li, Dr

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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 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