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

Consistency Evaluation of Drug Efficacy Between Clinical Systemic Treatment and Drug Sensitive Test Based on Patient-derived Organoid in Patients With Recurrent/Metastatic Salivary Gland Cancer: A Prospective, Multicenter, Observational Study

This project will test whether drugs that kill a patient’s tumor cells in lab-grown organoids match which systemic treatments help people with recurrent or metastatic salivary gland cancer.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Huashan Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT06686979 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with pathologically confirmed recurrent or metastatic salivary gland cancer who can provide tumor tissue for organoid culture, have ECOG 0–2, life expectancy over three months, and adequate organ function to tolerate systemic therapy.

Not a fit: Patients without available or viable tumor tissue, with poor performance status (ECOG >2) or severe organ dysfunction, or those with rapidly declining health are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could help clinicians choose systemic therapies more likely to work for individual patients by using organoid-based drug testing as a personalized guide.

How similar studies have performed: Organoid-based drug testing has shown promising concordance with clinical responses in several other tumor types, but its use specifically in recurrent/metastatic salivary gland cancer is novel and not yet widely validated.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (ACTIVE_NOT_RECRUITING)
• Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Lai-ping Zhong, MD, PhD — Huashan Hospital
• Study coordinator: Lai-ping Zhong, MD, PhD

Conditions: Salivary Gland Cancers, Patient Derived Organoid, Drug Sensitive Test in Vitro, Recurrent/metastatic salivary gland cancer, Patient-derived organoid, Drug sensitive test in vitro