Patient-derived-organoid (PDO) Guided Versus Conventional Therapy for Advanced Inoperable Abdominal Tumors

NCT05378048 | Withdrawn Phase 2 DMC

• 1 other identifier: PDO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Recent studies that ex vivo drug responses on PDO models across different solid tumours can predict treatment responses to chemotherapeutic agents. In patients with metastatic or inoperable solid abdominal tumours, we perform a PDO based drug screen and to identify drugs that will confer clinical response and compared to conventional treatments

Conditions

Organoids

Keywords

Organoids

Outcome Measures

Primary Outcomes (1)

• Tumor progression-free survival

  The length of time after patients have received treatment and have no detectable disease and have no detectable disease

  12 months after randomization

Secondary Outcomes (4)

• the rate of overall survival

  12 months after randomization

• tumour response rates

  12 months after randomization

• rate of successful organoid culture and drug screen organoid culture

  4-6 weeks after culture

• rate of serious adverse events

  12 months after randomization

Study Arms (2)

PDO-guided treatment

EXPERIMENTAL

A biopsy of the tumour will be performed for PDO culture and Genome-guided drug screening. An Multidisciplanary Tumour Board will review the drug screen results and recommend the use of a drug with a response in a PDO.

Drug: PDO-guided treatment

standard of care

EXPERIMENTAL

the standard of care will include all treatments that have been reported to improve survival or quality of life in randomized trials.

Drug: standard of care

Interventions

PDO-guided treatment DRUG

A biopsy of the tumour will be performed for PDO culture and Genome-guided drug screening. An Multidisciplanary Tumour Board will review the drug screen results and recommend the use of a drug with a response in a PDO.

PDO-guided treatment

standard of care DRUG

the standard of care will include all treatments that have been reported to improve survival or quality of life in randomized trials.

standard of care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients should be older than 18 years, able to provide written consents to trial participation, with Eastern cooperative oncology group performance status of 0 or 1, With measurable disease in accordance with response evaluation criteria in solid tumours (RECIST) version 11. \[ 10 \] With a neutrophil count, hemoglobin \> 9g/dl, serum creatinine \<1.5 x upper limit of normal, serum bilirubin \< 1.5 x normal, and aspartate and alanine aminotransferases (\<3 x ULN or \<5x in those with liver metastasis) Ejection Fraction \>50% of normal. The disease is accessible for a biopsy (radiologic or endoscopic) or resection of a metastatic site.

You may not qualify if:

• unable to give consent, could not obtain a biopsy

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of surgery , Prince of Wales Hospital

Hong Kong, N.T., Hong Kong

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: patients are randomized to PDO-guided treatment or standard of care.

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 17, 2022
• Study Start: July 4, 2022
• Primary Completion: July 3, 2025
• Study Completion: July 3, 2025
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)