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Effect of albumin paclitaxel on efficacy, safety and immune function of elderly patients with advanced gastric cancer after first-line treatment failure

Effect of albumin paclitaxel on efficacy, safety and immune function of elderly patients with advanced gastric cancer after first-line treatment failure

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026165
Enrollment
Unknown
Registered
2019-09-24
Start date
2019-10-01
Completion date
Unknown
Last updated
2019-09-30

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

Conditions

gastric cancer

Interventions

single arm:Albumin - bound taxol single agent chemotherapy

Sponsors

Affiliated Hospital of Qinghai University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 60 patients with advanced gastric cancer who were pathologically diagnosed and could obtain blood and tissue samples after first-line chemotherapy failed; (1) no previous chemotherapeutic drugs have been used; (2) at least one measurable lesion with chest X-ray, conventional CT or MRI scan >= 20mm and spiral CT >= 10mm; (3) aged 65 ~ 80 years, physical condition is good, ECOG<=2 points; (4) expected survival time is more than 3 months: (5) it meets the indications and basic requirements of chemotherapy, including: the peripheral blood image is basically normal, the functions of the heart, liver, kidney and other important organs are not obviously abnormal, the electrocardiogram is basically normal, and there is no unhealed wound on the body; (6) volunteer to participate in the study, with good compliance, able to cooperate with experimental observation, and sign the written informed consent.

Exclusion criteria

Exclusion criteria: (1) pregnant or lactating women, or female patients who are fertile but do not take contraceptive measures; (2) recent use of hormone therapy; (3) existing severe acute infection that has not been controlled;Or have suppurative sex and chronic infection, the wound does not heal; (4) patients with original severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe heart valve disease and intractable hypertension;New York heart association grade >= grade II cardiac insufficiency; (5) the number of neutrophils in peripheral blood was lower than 1500/mm3; (6) allergic to taxol or human blood albumin; (7) patients who participated in clinical trials of other drugs within 4 weeks; (8) patients with uncontrollable neurological, mental diseases or mental disorders, poor compliance, and uncooperative or narrating treatment responses;Patients with primary brain tumor or central nervous metastatic tumor whose condition is not under control and who have obvious high cranial pressure or neuropsychiatric symptoms.

Design outcomes

Primary

MeasureTime frame
CD4 and CD8 lymphocyte counts in peripheral blood;CD4 and CD8 lymphocyte counts in peripheral blood;

Countries

China

Contacts

Public ContactLuo Yushuang

Affiliated Hospital of Qinghai University

qfyluoyushuang@163.com+86 13897208152

Outcome results

None listed

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