Recruiting nowNot phased
What this trial is trying to do
The researchers are testing whether DNA sequencing (NGS) and patient-derived organoids—three-dimensional mini-tumours grown from a person’s cancer—can identify treatments likely to work for advanced or inoperable solid tumours, including cancers that no longer respond to chemotherapy. The organoids will be exposed to different drugs in the laboratory, and the results will help guide each patient’s treatment.
The idea is that testing drugs on a patient’s own tumour cells could provide a more personalised choice than relying only on standard treatment options or genomic findings alone. The trial will measure tumour response, but it has no comparison group and does not directly test whether this approach helps people live longer or delays cancer growth.
Worth knowing: This is a small, non-randomised, unphased study, so a tumour response cannot by itself show that organoid-guided treatment is better than usual care.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT06077591 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | open label |
| Taking part | 40 people (planned) |
| Who can join | aged 18 Years to 100 Years |
| Run by | Chinese University of Hong Kong |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Other Patient-Derived Tumor Organoids
What it is measuring
tumor response
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Not phased. Not a drug-phase trial. Often a device, a procedure, or a change in how care is delivered.
How the researchers describe it
Precision oncology aims to improve clinical outcome of patients by offering personalized treatment through identifying druggable genomic aberrations within their tumors. This is particularly valid when it comes to offering alternative treatment options for patients with advanced tumors that are chemo-refractory. Patient-derived organoids (PDOs) are 3 dimensional tumoroids that can be expanded ex vivo and are both pheno- and genotypically identical to patients' tumors. Observational studies have shown that PDO-based drug screens can predict treatment response with high sensitivity and specificity. Vlachogiannis G. reported a living biobank of patient-derived organoids (PDOs) from patients with advanced GI cancers enrolled in clinical trials. PDOs can recapitulate patients' clinical response to chemotherapeutic agents. In 19 tumor organoids, the group performed molecular profiling and drug screens and then compared ex vivo organoid responses to anticancer drugs. Drug response to PDO based orthotopic mouse tumor xenografts correlated to the drug response of the patient in clinical trials. Further to the study, there were other retrospective validation studies utilizing PDOs from patients enrolled in clinical trials such as the TUMOROID, CinClare to predict clinical response.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- patients with metastatic, inoperable or advanced solid tumors who are refractory to at least one standard chemo- or targeted drugs.
- The disease is accessible for a biopsy (radiologic or endoscopic) or resection of a metastatic site.
- These patients are seen at a multidisciplinary tumor board meeting prior to referrals.
- aged >18 years, able to provide written consents to trial participation,
- with an Eastern cooperative oncology group performance status of 0 or 1,
- with measurable disease in accordance with response evaluation criteria in solid tumors (RECIST) version 1.1.
- deem suitable for standard chemo-therapy; i.e. with a normal neutrophil count, hemoglobin > 9g/dl, serum creatinine, <1.5 x upper limit of normal, bilirubin < 1.5 x normal, Aspartate and alanine aminotransferases (<3 x ULN or <5x
- those with liver metastasis) and with an ejection Fraction >50% of normal on echocardiography.
Exclusion Criteria
- unable to provide informed consent
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: Hong Kong.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT06077591, registered by Chinese University of Hong Kong on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.