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Study on the efficacy of targeted therapy and immunotherapy for osteosarcoma based on organoids

Predicting Efficacy and Investigating Drug Resistance Mechanisms of Combined Antiangiogenesis-Immunotherapy for Advanced Osteosarcoma in a Vascularized Osteosarcoma Organoid-PBMC Co-Culture System

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600124906
Enrollment
Unknown
Registered
2026-05-19
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

bone tumor

Interventions

Observation group:None

Sponsors

The Second Hospital of Jiaxing
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Osteosarcoma patients aged =12 years, with no gender restriction. 2.Imaging examination suggests the possibility of a malignant tumor, and diagnostic biopsy or surgical resection of the primary tumor is planned. 3.ECOG performance status 0-1, with a life expectancy of >3 months. 4.Tumor tissue that can be obtained in sufficient quantity for pathological diagnosis and in vitro organoid culture. 5.Normal function of major organs, or deemed able to tolerate chemotherapy, targeted therapy, and immunotherapy after evaluation by the MDT team. 6.The criteria for blood routine examination must meet the following: WBC = 4.0×10^9/L, ANC = 1.5×10^9/L, PLT = 80×10^9/L, Hb = 90 g/L (without blood transfusion or blood product administration within 14 days, and without the use of G-CSF or other hematopoietic growth factors for correction). 7.Biochemical examination must meet the following criteria: serum albumin = 3.0 g/dL (30 g/L), TBIL = 1.5 × ULN, ALT and AST = 2.5 × ULN, BUN and CRE = 1.5 × ULN, or endogenous creatinine clearance rate = 60 mL/min (Cockcroft-Gault formula). 8.Good coagulation function: defined as international normalized ratio (INR) or prothrombin time (PT) = 1.5 × ULN; if the subject is receiving anticoagulation therapy, it is acceptable as long as the PT is within the intended therapeutic range of the anticoagulant drug. 9.Able to understand the content of the informed consent form, sign the informed consent form, and be willing to cooperate with relevant follow-up visits.

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant or breastfeeding; 2. Severe liver disease (such as cirrhosis), kidney disease, respiratory system disease, blood system disease, or endocrine system disease, with uncontrolled condition; 3. Patients infected with HIV, or with active hepatitis B (HBV-DNA = 10^4 copies/ml) or hepatitis C (hepatitis C antibody positive and HCV-RNA above the detection limit of the analysis method), with uncontrolled condition; 4. Within the past 6 months, any of the following conditions occurred: myocardial infarction, severe/unstable angina, NYHA class =2 heart failure, clinically significant supraventricular or ventricular arrhythmia, or symptomatic congestive heart failure, with uncontrolled condition; 5. Patients with mental illness or a known history of abuse of psychiatric drugs or drug addiction; 6. Having other types of malignancies; 7. Having other serious physical or mental diseases or abnormal laboratory tests that may increase the risk of participating in the study, or interfere with study results, or patients deemed unsuitable to participate by the investigator; 8. Known allergy to the study drug or any of its excipients; or having experienced severe allergic reactions to other monoclonal antibodies; 9. Patients unable to give consent, or unable to obtain the required tumor tissue for pathological diagnosis and experiments; 10. Withdrawal of informed consent;

Design outcomes

Primary

MeasureTime frame
Survival status of osteosarcoma organoids;Expression of candidate membrane proteins;

Countries

China

Contacts

Public ContactHuanhuan Luo

The Second Hospital of Jiaxing

luohuanhuan@jxey.com+86 573 8208 2936

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026