Actively Recruiting
PDO Based Drug Sensitive Test in R/M HNSCC
Led by Huashan Hospital · Updated on 2025-09-03
100
Participants Needed
2
Research Sites
189 weeks
Total Duration
On this page
Sponsors
H
Huashan Hospital
Lead Sponsor
S
Shanghai Cancer Hospital, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PDO Based Drug Sensitive Test in R/M HNSCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC)
- Availability of tumor tissue for organoid culture
- ECOG performance status score between 0 and 2
- Life expectancy greater than 3 months
- Normal major organ function and tolerable to chemotherapy, targeted therapy, or immunotherapy, including specific blood counts and biochemical criteria
- Ability to understand and sign the informed consent form and willingness to cooperate with follow-up
You will not qualify if you...
- Presence of metastatic tumors in the head and neck region not classified as HNSCC, such as sarcoma, adenocarcinoma, or nasopharyngeal carcinoma
- Known allergy to study drugs, their active ingredients, excipients, or severe allergic reactions to monoclonal antibodies
- Pregnant or breastfeeding women, or women of childbearing age with positive pregnancy test or refusal to use contraception during the study and 2 months after last medication
- Severe uncontrolled liver, kidney, respiratory, hematopoietic, or endocrine diseases
- Infection with HIV, active hepatitis B or C with high viral load, or other uncontrolled diseases
- Serious cardiovascular events within 6 months before enrollment, including myocardial infarction, severe angina, heart failure NYHA class 2 or above, arrhythmias, or symptomatic congestive heart failure
- History of mental illness, psychiatric drug abuse, or drug addiction
- Inability to give consent or provide sufficient tumor tissue for study
- Other serious physical or mental conditions or lab abnormalities that increase risk or interfere with study results, or deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Active, Not Recruiting
2
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
L
Lai-ping Zhong, MD, PhD
CONTACT
T
Tong-chao Zhao, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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