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Study on the preventive effect of Cosela on chemotherapy induced Bone marrow suppression in patients with advanced gastric cancer receiving systemic treatment

Study on the preventive effect of Cosela on chemotherapy induced Bone marrow suppression in patients with advanced gastric cancer receiving systemic treatment

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073043
Enrollment
Unknown
Registered
2023-06-30
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-07-02

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

Conditions

gastric cancer

Interventions

intervention group:Systemic chemotherapy with Cosela

Sponsors

The First Affiliated Hospital of Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18~75 years old, male and female; 2. Patients with gastric adenocarcinoma confirmed by histopathology or cytology; 3. No prior systemic therapy, including chemotherapy, radiotherapy, immunotherapy and targeted therapy; 4.ECOG PS score 0-1; 5. Expected survival = 3 months; 6. Patients with normal function of major organs and no serious functional abnormalities of blood, heart, lung, liver, kidney, bone marrow or immune deficiency shall meet the following requirements in laboratory examination: hemoglobin (Hb) =90 g/L; White blood cell (WBC) =3.0×109/L; Neutrophil count (NEUT) =1.5×109/L; Platelet (PLT) =90×109/L; Liver function (AST or ALT) level =2.5 times the upper limit of normal (ULN); Renal function (serum creatinine sCr) level =1.5 times the upper limit of normal (ULN); Total bilirubin (TBIL) =1.5 times the upper limit of normal (ULN); Urinary protein and urinary occult blood < 2+; Fecal occult blood < 2+; 7. The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up; 8. Researchers believe treatment can be beneficial. Physical condition score PS=2 points; 9. Patients and their families are able to understand and willing to participate in this study and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Proven allergy to the test drug and/or its excipients; 2. Subjects who have received or are receiving additional chemotherapy, radiation, targeted, or immunotherapy; 3. Have any active autoimmune disease or history of autoimmune disease; 4. Have clinical symptoms or diseases of heart that are not well controlled, such as: NYHA2 or above heart failure; Unstable angina pectoris; Myocardial infarction within 1 year; 5. Pregnant or lactating women; 6. Patients with acute infection requiring antibiotic treatment; 7. Hepatitis B or hepatitis C antibody positive; 8.HIV antibody positive; 9. Other diseases considered by the study physician to affect the prognosis of survival; 10. Other conditions considered by the study physician to be inconsistent with this study.

Design outcomes

Primary

MeasureTime frame
neutrophil;

Secondary

MeasureTime frame
Overall survival rate; tolerance;

Countries

China

Contacts

Public ContactJipeng Li

The First Affiliated Hospital of Air Force Military Medical University

364477087@qq.com+86 139 9131 6190

Outcome results

None listed

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