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Study on the establishment of individualized chemotherapeutic drug evaluation system for gastric cancer by conditional reprogramming culture

Study on the establishment of individualized chemotherapeutic drug evaluation system for gastric cancer by conditional reprogramming culture

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000034277
Enrollment
Unknown
Registered
2020-06-30
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-07-06

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

Conditions

Gastric cancer

Interventions

Group of i-CR:Nil

Sponsors

Shandong Tumor Hospital and Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Agreed to follow the experimental treatment plan and visit plan and signed written informed consent; 2) The age of screening is 18 to 75 years old (including upper and lower limits), with no limitation on gender; Gastric adenocarcinoma (including gastroesophageal junction adenocarcinoma) was confirmed histopathologically and/or cytologically, and was determined by the investigator to be suitable for treatment with clinically common chemotherapy regimens; 3) During the screening period, information related to the choice of treatment plan can be provided, including age, concomitant disease, previous treatment, treatment intention, economic status, etc.; 4) Fresh tumor tissue samples needed for drug sensitivity screening can be provided through gastroscopy or surgery during the screening period; 5)ECOG functional status score 0~1; 6) Has fully recovered from any toxicity associated with prior surgery and prior cancer treatment, as determined by the investigator; 7) by the researchers to determine with sufficient bone marrow, liver, kidney and blood coagulation function, can be the reference of evaluation index has absolute neutrophil count, platelet, hemoglobin, serum total bilirubin, alanine aminotransferase (ALT), aspertate aminotransferase (AST) and alkaline phosphatase (ALP), serum creatinine, international standardization ratio (INR), activated partial coagulation time (APTT) live enzymes, etc.; 8) Expected survival >= 3 months.

Exclusion criteria

Exclusion criteria: 1) Those who are known to be her2-positive and suitable for her2-targeted drug therapy; 2) Subjects with evidence of a serious or uncontrollable systemic disease (such as unstable or unremunerated respiratory, heart, liver or kidney disease, uncontrolled infection, etc.) as determined by the investigator; 3) Patients with obvious contraindications to conventional chemotherapy drugs for gastric cancer (including platinum, fluorouracil, taxanes and irinotekang) according to the judgment of the researchers (because these patients cannot be guided to use individual drugs according to the results of drug sensitivity screening in vitro); 4) The researchers believe that the only appropriate chemotherapy regimen can be determined based on the patient's age, physical condition, concomitant disease, previous treatment, patient's intention, and economic condition. 5) In addition to gastric cancer, the patient has suffered from another malignant tumor in the past 5 years, except the malignant tumor such as cervical cancer in situ and non-melanoma skin cancer that has received curative treatment and has not recurred within 5 years; 6) Pregnant or lactating female patients; 7) Participating in clinical studies and using experimental drugs within 30 days before screening; 8) Other conditions, such as poor compliance, that the researcher considers inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Objective mitigation rate (ORR);Disease control rate (DCR);Duration of remission (DOR);

Countries

China

Contacts

Public ContactChai Jie

Shandong Tumor Hospital and Institute

chaijie3@126.com+86 18678867800

Outcome results

None listed

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