Cancer Patients With Solid TumorsOPTinNCT07468422
Organotypic Platform for Therapeutic Investigation (OPTin) for Guiding Cancer Patients Treatment
An observational study of Cancer Patients With Solid Tumors and Cancer (Advanced Stage), run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to learn whether a new laboratory method called OPTin can help doctors select the most effective, personalized cancer therapies for patients with advanced or treatment-resistant tumors. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cancer Patients With Solid Tumors, Cancer (Advanced Stage)
- What is being tested?
- OPTin: Organotypic Platform for Therapeutic Investigation
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Oct 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients will receive treatments in CMUH.
Who may be able to join
- Adults aged 18 years or older.
- Willing to sign the informed consent form prior to any study-related procedures.
- Histologically confirmed participants with metastatic or advanced solid tumor that is not curable with local therapies.
- Able to provide a tissue specimen larger than [(0.5 cm)³] via surgery during the screening period.
- Willing to allow the use of their previous test data and leftover tissue samples for analysis.
Who cannot join
- Patients who are unable to provide sufficient tissue samples via surgery.
- The investigator determines that the patient is not eligible for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Repurposing Drugs Guided by Tissue Slice Screening in Cancer Patients Without Standard Treatment
The goal of this clinical trial is to learn whether a new laboratory method called OPTin can help doctors select the most effective, personalized cancer therapies for patients with advanced or treatment-resistant tumors. The study will also learn about the safety and feasibility of using OPTin to guide treatment decisions across different cancer types.
The main questions it aims to answer are:
Read more
Does OPTin accurately identify which drugs or drug combinations work best for each patient's tumor?
Does OPTin-guided therapy improve tumor response or remission rates when the patients don't have any standard treatment selection?
Study Design:
Researchers will collect treatment outcomes in patients whose therapy is chosen based on OPTin results or not in cancer patients without standard treatment.
Participants will:
Provide a small tumor tissue sample for OPTin testing.
Receive either a drug or drug combination identified by OPTin, or a physician's decision treatment.
Visit the clinic regularly for imaging, blood tests, and side-effect monitoring.
Be followed for several months to evaluate treatment response and overall health.
Example Case:
In a previous proof-of-concept study, OPTin screening in a patient with advanced hypopharyngeal carcinoma identified venetoclax as effective for the primary tumor and lenvatinib as a sensitizing agent for metastasis. Combination therapy led to near-complete remission and a significant drop in serum AFP levels.
These results support evaluating OPTin in a prospective clinical trial involving diverse cancer types to confirm its usefulness in guiding precision oncology.
- Being tested
- OPTin: Organotypic Platform for Therapeutic Investigation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTin: Organotypic Platform for Therapeutic InvestigationOther
a screening system that integrates organotypic tissue slice cultures, optical clearing, and high-resolution fluorescence imaging.
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Measured: through study completion, an average of 1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start27 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Patients With Solid TumorsStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical University, Taiwan
- Responsible party
- Principal investigator, Ching Yun Hsieh, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468422
- Sponsor's protocol ID
- CMUH114-REC1-159
- Acronym
- OPTin
- Status last verified
- Oct 2025
- First submitted
- 22 Nov 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repurposing Drugs Guided by Tissue Slice Screening in Cancer Patients Without Standard Treatment
- ClinicalTrials.gov ID
- NCT07468422
- Acronym / sponsor ID
- OPTin / CMUH114-REC1-159
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- China Medical University, Taiwan
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether a new laboratory method called OPTin can help doctors select the most effective, personalized cancer therapies for patients with advanced or treatment-resistant tumors. The study will also learn about the safety and feasibility of using OPTin to guide treatment decisions across different cancer types.
The main questions it aims to answer are:
Does OPTin accurately identify which drugs or drug combinations work best for each patient's tumor?
Does OPTin-guided therapy improve tumor response or remission rates when the patients don't have any standard treatment selection?
Study Design:
Researchers will collect treatment outcomes in patients whose therapy is chosen based on OPTin results or not in cancer patients without standard treatment.
Participants will:
Provide a small tumor tissue sample for OPTin testing.
Receive either a drug or drug combination identified by OPTin, or a physician's decision treatment.
Visit the clinic regularly for imaging, blood tests, and side-effect monitoring.
Be followed for several months to evaluate treatment response and overall health.
Example Case:
In a previous proof-of-concept study, OPTin screening in a patient with advanced hypopharyngeal carcinoma identified venetoclax as effective for the primary tumor and lenvatinib as a sensitizing agent for metastasis. Combination therapy led to near-complete remission and a significant drop in serum AFP levels.
These results support evaluating OPTin in a prospective clinical trial involving diverse cancer types to confirm its usefulness in guiding precision oncology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will receive treatments in CMUH.
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Willing to sign the informed consent form prior to any study-related procedures.
- Histologically confirmed participants with metastatic or advanced solid tumor that is not curable with local therapies.
- Able to provide a tissue specimen larger than [(0.5 cm)³] via surgery during the screening period.
- Willing to allow the use of their previous test data and leftover tissue samples for analysis.
Key exclusion criteria (2 listed)
- Patients who are unable to provide sufficient tissue samples via surgery.
- The investigator determines that the patient is not eligible for enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPTin: Organotypic Platform for Therapeutic Investigationa screening system that integrates organotypic tissue slice cultures, optical clearing, and high-resolution fluorescence imaging. | Other | – |
Primary outcome
response rate
Time frame: through study completion, an average of 1 year"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Patients With Solid Tumors and Cancer (Advanced Stage), run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: through study completion, an average of 1 year"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.