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Recombinant Human Thrombopoietin Combined with hetrombopag in Treating Thrombocytopenia Caused by Radiochemotherapy in Nasopharyngeal Carcinoma

Recombinant Human Thrombopoietin Combined with hetrombopag in Treating Thrombocytopenia Caused by Radiochemotherapy in Nasopharyngeal Carcinoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081992
Enrollment
Unknown
Registered
2024-03-18
Start date
2023-05-31
Completion date
Unknown
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nasopharyngeal carcinoma

Interventions

experimental group:Recombinant Human Thrombopoietin Combined with hetrombopag

Sponsors

zhejiang cancer hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1: Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type). 2: Tumor staged as T3-4N1/N2-3 (according to the 8th American Joint Commission on Cancer edition). 3: No evidence of distant metastasis (M0). 4: Patients must be informed of the investigational nature of this study and give written informed consent. 5: Receiving induction chemotherapy and sequential synchronous radiochemotherapy 6: Satisfactory performance status: Karnofsky scale (KPS) > 70. Adequate marrow: leucocyte count =4000/µL, hemoglobin =90g/L and platelet count =100000/µL. Normal liver function test: Alanine Aminotransferase (ALT)Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) =2.5×ULN, and bilirubin =ULN. Adequate renal function: creatinine clearance =60 ml/min. 7:Aged = 18 years and = 75 years 8:The Eastern Cooperative Oncology Group (ECOG) score: 0~1 point 9:Platelet < 50x10^9/L;

Exclusion criteria

Exclusion criteria: 1: WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. 2: Treatment with palliative intent. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. 3: Pregnancy or lactation. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume). 4: Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.

Design outcomes

Primary

MeasureTime frame
he proportion of subjects who were effective after a week of treatment with Herombopag Olamine Tabletsin and Recombinant Human Thrombopoietin was defined as having platelet values restored to >= 75x10^9/L;

Secondary

MeasureTime frame
Proportion of patients whose platelet values recovered to >= 100x10^9/L after Herombopag Olamine Tabletsin therapy;Platelet infusion rate after Herombopag Olamine Tabletsin treatment;safety;The incidence of reduced cycle chemotherapy intensity due to thrombocytopenia (reduced or delayed chemotherapy);

Countries

china

Contacts

Public Contactting jin

zhejiang cancer hospital

jinting@zjcc.org.cn+86 159 6883 7040

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026