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Exploratory clinical study for the efficacy of PD-1 monoclonal antibody in tumor organoids

Exploratory clinical study for the efficacy of PD-1 monoclonal antibody in tumor organoids

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900028090
Enrollment
Unknown
Registered
2019-12-11
Start date
2019-12-30
Completion date
Unknown
Last updated
2019-12-16

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

Conditions

Malignant tumor

Interventions

Case series:pd-1 inhibitor

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. male or female, aged 18 to 70 years; 2. locally advanced and metastatic malignant tumor confirmed by histological and/or cytological examinations; 3. Imaging diagnosis has at least one measurable lesion based on recist1.1; the expected survival time is longer than 12 weeks, and can be followed up; 4. fresh tumor tissue can be obtained; 5. physical condition: ECOG score is less than or equal to 2 points; 6. the results of blood routine, liver, kidney function and hemagglutination tests met the following criteria: neutrophil(> 1.5 *10^9/L), hemoglobin(> 90g/L), platelet(>100*10^9/L),aspartate aminotransferase (AST) normal upper limit), alanine aminotransferase (ALT) < 2.5 ULN, total bilirubin (TIBC) < 1.5 ULN, serum creatinine (CR) < 1.5 ULN; 7.patients voluntarily signed informed consent and had good compliance.

Exclusion criteria

Exclusion criteria: 1. BMI =10% within 2 months before screening; 2. history of gastrointestinal perforation or fistula or a high risk of bleeding within half a year before medication; 3. Previous allergies to monoclonal antibodies, use of other immunosuppressants within 2 weeks before medication, vaccination of anti-tumor vaccine, active autoimmune disease, history of autoimmune disease, history of immunodeficiency disease, history of interstitial pneumonia, etc.; 4. Other serious diseases that may affect follow-up and short-term survival.

Design outcomes

Primary

MeasureTime frame
drug sensitivity;

Countries

China

Contacts

Public ContactXianbao Zhan

Shanghai Changhai Hospital

zhanxianbao@126.com+86 13501850100

Outcome results

None listed

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