PDO Based Drug Sensitive Test in R/M HNSCC

NCT06686342 | Recruiting

• 1 other identifier: DST-PDO-HNSCC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Squamous Cell Carcinoma; Patient Derived Organoid; Drug Sensitive Test in Vitro

Keywords

Recurrent/metastatic head and neck squamous cell carcinoma; Patient-derived organoid; Drug sensitive test in vitro

Outcome Measures

Primary Outcomes (2)

• 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).

  2 years

• 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).

  2 years

Secondary Outcomes (4)

• The success rate of establishment and drug sensite test on PDO

  2 years

• Tumor Growth Inhibition of PDO

  2 weeks

• Overall Survival

  2 years

• Progression-Free Survival

  2 years

Study Arms (1)

Observational cohort

The observational group of patients with R/M HNSCC would receive drug treatment according to the clinical guideline or doctor's experience. No intervention would be provided based on the drug sensitive test from patient-derived organoid.

Other: No intervention; Other: No Intervention: Observational Cohort

Interventions

No intervention OTHER

The 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.

Observational cohort

No Intervention: Observational Cohort OTHER

The 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.

Observational cohort

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huashan Hospital: lead
• 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

Study Sites (2)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

ACTIVE NOT RECRUITING

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Related Publications (2)

• Pasch CA, Favreau PF, Yueh AE, Babiarz CP, Gillette AA, Sharick JT, Karim MR, Nickel KP, DeZeeuw AK, Sprackling CM, Emmerich PB, DeStefanis RA, Pitera RT, Payne SN, Korkos DP, Clipson L, Walsh CM, Miller D, Carchman EH, Burkard ME, Lemmon KK, Matkowskyj KA, Newton MA, Ong IM, Bassetti MF, Kimple RJ, Skala MC, Deming DA. Patient-Derived Cancer Organoid Cultures to Predict Sensitivity to Chemotherapy and Radiation. Clin Cancer Res. 2019 Sep 1;25(17):5376-5387. doi: 10.1158/1078-0432.CCR-18-3590. Epub 2019 Jun 7.

  PMID: 31175091 BACKGROUND

• Vlachogiannis G, Hedayat S, Vatsiou A, Jamin Y, Fernandez-Mateos J, Khan K, Lampis A, Eason K, Huntingford I, Burke R, Rata M, Koh DM, Tunariu N, Collins D, Hulkki-Wilson S, Ragulan C, Spiteri I, Moorcraft SY, Chau I, Rao S, Watkins D, Fotiadis N, Bali M, Darvish-Damavandi M, Lote H, Eltahir Z, Smyth EC, Begum R, Clarke PA, Hahne JC, Dowsett M, de Bono J, Workman P, Sadanandam A, Fassan M, Sansom OJ, Eccles S, Starling N, Braconi C, Sottoriva A, Robinson SP, Cunningham D, Valeri N. Patient-derived organoids model treatment response of metastatic gastrointestinal cancers. Science. 2018 Feb 23;359(6378):920-926. doi: 10.1126/science.aao2774.

  PMID: 29472484 BACKGROUND

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Lai-ping Zhong, MD, PhD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lai-ping Zhong, MD, PhD

CONTACT

+862152888915; zhonglp@hotmail.com

Tong-chao Zhao, MD, PhD

CONTACT

+862152889999; 961497591@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 13, 2024
• Study Start: March 26, 2025
• Primary Completion (Estimated): November 11, 2026
• Study Completion (Estimated): November 11, 2028
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2 years after completion of the study, for 6 months.
• Access Criteria: Access to IPD data can be obtained upon scientifically sound request from the study PI, who will contact the Clinical Research Unit, Huashan Hospital, Fudan University. Access will be released after the approval from the Clinical Research Unit.

Locations

CN (2)