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Clinical study for thioepipstatin in the prevention of chemotherapy-related neutropenia in nasopharyngeal carcinoma

A prospective, one-arm, single-center clinical study of thioepipstatin for the prevention of chemotherapy-related neutropenia in nasopharyngeal carcinoma

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025453
Enrollment
Unknown
Registered
2019-08-26
Start date
2019-09-11
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

Nasopharyngeal carcinoma

Interventions

Treatment Group: thioepipstatin

Sponsors

Zhejiang Province Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years, both men and women; 2. Histological or cytologically confirmed locally advanced (stage III~IV) nasopharyngeal carcinoma; 3. The patient intends to receive induction chemotherapy or receive neutropenia or FN during the treatment of the above-mentioned regimen; 4. ECOG PS score = 90 g / L; WBC >= 4.0 x 10^9 / L; ANC >= 2.0 x 10^9 / L; PLT >= 100 x 10^9 / L b) Liver function, biochemical examination: ALT and AST <= 1.5 x ULN; total bilirubin <= 1.5 x ULN; serum creatinine (Cr) <= 1.5 x ULN. 8. Patients with good compliance, volunteered to join the study, signed informed consent; 9. Patients who the investigator believes can benefit;

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Previously suffered from other malignant tumors (except for stage I non-melanoma skin cancer or cervical carcinoma in situ); 3. Have received radiotherapy or chemotherapy before enrollment; 4. Clinical diagnosis of splenomegaly; 5. According to the investigator's judgment, there are serious concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study; 6. Those who are allergic to research drugs, polyethylene glycol recombinant human granulocyte stimulating factor, recombinant human granulocyte stimulating factor, and other preparations for expression of E. coli; 7. Persons with a history of psychotropic substance abuse who are unable to quit or have a mental disorder; 8. The investigator judges other situations that may affect the clinical study and the results of the study, and are not suitable for inclusion in the study; 9. HIV positive patients (except HIV patients with malignant lymphoma); 10. Patients who are considered by the doctor to be unsuitable for the study drug.

Design outcomes

Primary

MeasureTime frame
FN Incidence rate;

Countries

China

Contacts

Public ContactChen Xiaozhong

Zhejiang Province Cancer Hospital

cxzfyun@sina.com+86 13505717886

Outcome results

None listed

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