NCT06686342 PDO Based Drug Sensitive Test in R/M HNSCC
| NCT ID | NCT06686342 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Huashan Hospital |
| Condition | Head and Neck Squamous Cell Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-03-26 |
| Primary Completion | 2026-11-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-03-26 with a primary completion date of 2026-11-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the consistency of drug efficacy between the clinical systemic treatment and drug sensitive test based on patient-derived organoid in R/M HNSCC patients, using a prospective and multicenter observational study to increase the generalizability and reliability of research conclusion.
Eligibility Criteria
Inclusion Criteria: * Pathologically confirmed R/M HNSCC 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-HNSCC such as sarcoma, adenocarcinoma, 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
Contact & Investigator
Lai-ping Zhong, MD, PhD
PRINCIPAL INVESTIGATOR
Huashan Hospital
Frequently Asked Questions
Who can join the NCT06686342 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Head and Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06686342 currently recruiting?
Yes, NCT06686342 is actively recruiting participants. Contact the research team at zhonglp@hotmail.com for enrollment information.
Where is the NCT06686342 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China.
Who is sponsoring the NCT06686342 clinical trial?
NCT06686342 is sponsored by Huashan Hospital. The principal investigator is Lai-ping Zhong, MD, PhD at Huashan Hospital. The trial plans to enroll 100 participants.