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

Qualifiers

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 design

Treatments tested in this trial

  • No intervention
  • No Intervention: Observational Cohort

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators

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