PDO Based Drug Sensitive Test in R/M HNSCC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorHuashan Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
Pathologically confirmed R/M HNSCC patients
Tumor tissues available for organoid culture
ECOG score: 0-2 points
Life expectancy > 3 months
Disqualifiers
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
Trial population
This study is an observational study, according to previous literature reports combined with the actual clinical situation of institution/collaborating institutions, a total of 100 participants are planned to be included.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionThe patients with R/M HNSCC would receive drug treatment according to the clinical guideline or doctor's experience, at the same time, tumor biopsy samples would be collected to establish PDO for drug sensitive test. But no intervention would be used based on the PDO drug sensitive test.
No Intervention: Observational Cohort
Other interventionThe patients with R/M HNSCC would receive drug treatment according to the clinical guideline or doctor's experience, at the same time, tumor biopsy samples would be collected to establish PDO for drug sensitive test. But no intervention would be used based on the PDO drug sensitive test.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Observational cohort2 interventions
Trial outcomes
Primary outcomes
1
Objective Response Rate
The proportion of patients whose tumor size is reduced to a pre-specified value and maintained for a minimum required duration, which is the sum of the proportions of Complete Response (CR) and Partial Response (PR).
Time frame
2 years2
Disease Control Rate
The proportion of patients whose tumor size is reduced or stable and maintained for a minimum required duration, which is the sum of the proportions of Complete Response (CR), Partial Response (PR), and Stable Disease (SD).
Time frame
2 yearsSecondary outcomes
1
The success rate of establishment and drug sensite test on PDO
Number of successful organoid construction and completion of drug sensitive test/Total number of participants ×100%.
Time frame
2 years2
Tumor Growth Inhibition of PDO
(1-T/C) × 100%, where T is the survival rate of PDO drug treatment group, and C is the survival rate of PDO control group.
Time frame
2 weeks3
Overall Survival
The time from enrollment of participants to death (for any reason).
Time frame
2 years4
Progression-Free Survival
The time from enrollment of participants to occurrence of tumor progression (in any aspect) or death (for any reason).
Time frame
2 yearsSponsors and contacts
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Huashan Hospital
Lead sponsor
Shanghai Cancer Hospital, China
Collaborator
Eye & ENT Hospital of Fudan University
Collaborator
Dongfang Hospital Affiliated to Tongji University
Collaborator
Shandong Cancer Hospital and Institute
Collaborator
Qilu Hospital of Shandong University
Collaborator
Shandong Provincial Hospital
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Tongji Hospital
Collaborator
Hospital of Stomatology, Wuhan University
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
First Affiliated Hospital of Zhejiang University
Collaborator
Sir Run Run Shaw Hospital
Collaborator
Zhejiang Cancer Hospital
Collaborator
Shanghai Zhongshan Hospital
Collaborator
Shanghai Huangpu District Central Hospital
Collaborator
Source ClinicalTrials.gov