Patient-derived organoid drug sensitivity testing for recurrent or metastatic salivary gland cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter observational project collects tumor tissue from people with recurrent or metastatic salivary gland cancer and grows patient-derived organoids in the lab. Researchers run in vitro drug sensitivity tests on those organoids and record which drugs show activity. They then compare the organoid drug responses with the actual clinical systemic treatments and outcomes for the same patients. Conducting the work across multiple Shanghai cancer centers aims to improve the reliability and generalizability of the findings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Pathologically confirmed R/M SGC patients
* Tumor tissues available for organoid culture
* ECOG score: 0-2 points
* Life expectancy \> 3 months
* Normal major organ function, tolerable to chemotherapy, targeted therapy, immunotherapy: a. Hematology examination criteria must meet: WBC≥4.0×109/L, ANC≥1.5×109/L, PLT≥80×109/L, Hb≥90 g/L (no blood transfusion or blood products within 14 days, no use of G-CSF or other hematopoietic growth factors); b. Biochemical examination must meet the following criteria: serum albumin≥3.0 g/dL (30 g/L), TBIL≤1.5×ULN, ALT, AST≤2.5×ULN, BUN and CRE≤1.5×ULN or endogenous creatinine clearance≥60 ml/min (Cockcroft-Gault formula); c. Good coagulation function: defined as International Normalized Ratio (INR) or Prothrombin Time (PT)≤1.5 times ULN; if the study participant is on anticoagulant therapy, as long as PT is within the intended range of the anticoagulant medication
* Able to understand the content of informed consent form, sign the informed consent form, and willing to cooperate with the follow-up

Exclusion Criteria:

* Metastatic tumors in the head and neck region, or non-salivary gland cancer tumors such as sarcoma, squamous cell carcinoma, nasopharyngeal carcinoma, etc.
* Known allergy to the study drugs or their active ingredients or any excipients; or had a severe allergic reaction to other monoclonal antibodies
* Pregnant or breastfeeding female patients; or women of childbearing age with positive pregnancy test results (serum or urine) within 7 days before enrollment, or negative results but refusing to use effective contraception during the study period and 2 months after the last administration of study medication; or male patients with partners of childbearing age, refusing to use effective contraception during the study period and 2 months after the last administration of study medication
* Severe liver diseases (such as cirrhosis), kidney diseases, respiratory system diseases, hematopoietic system diseases, or endocrine system diseases, uncontrolled diseases
* Infected with HIV, active hepatitis B (HBV-DNA≥104 copies/ml) or hepatitis C (hepatitis C antibody positive, and HCR-RNA above the lower limit of detection of the analytical method), uncontrolled diseases
* Within 6 months before enrollment, the following conditions occurred: myocardial infarction, severe/unstable angina, NYHA class 2 or above heart failure, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure, uncontrolled diseases
* Patients with mental illness or known history of psychiatric drug abuse or drug addiction
* Unable to give consent, unable to obtain the required amount of tumor tissue for the study
* Other serious physical or mental diseases or laboratory test abnormalities that may increase the risk of participating in the study or interfere with the study results; or any other situation that the researchers deem unsuitable for participation in this study

Where it's running

• Huashan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• Huashan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Active not recruiting

Study contacts

• Principal investigator: Lai-ping Zhong, MD, PhD — Huashan Hospital
• Study coordinator: Lai-ping Zhong, MD, PhD
• Email: zhonglp@hotmail.com
• Phone: +862152888915

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.