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Active, not recruitingNCT07468422OPTinUpdated Mar 12, 2026

Organotypic Platform for Therapeutic Investigation (OPTin) for Guiding Cancer Patients Treatment

An observational study in Cancer Patients With Solid Tumors and Cancer (Advanced Stage), sponsored by China Medical University Hospital. Active, not recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by China Medical University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 85 Years
Sex
All
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Study 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. 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.

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Conditions studied

  • Cancer Patients With Solid Tumors
  • Cancer (Advanced Stage)

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 200 is close to the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The patients will receive treatments in CMUH.

Inclusion criteria

  1. Adults aged 18 years or older.
  2. Willing to sign the informed consent form prior to any study-related procedures.
  3. Histologically confirmed participants with metastatic or advanced solid tumor that is not curable with local therapies.
  4. Able to provide a tissue specimen larger than [(0.5 cm)³] via surgery during the screening period.
  5. Willing to allow the use of their previous test data and leftover tissue samples for analysis.

Exclusion criteria

Exclusion Criteria:

  1. Patients who are unable to provide sufficient tissue samples via surgery.
  2. The investigator determines that the patient is not eligible for enrollment.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • OtherOPTin: Organotypic Platform for Therapeutic Investigation

    a screening system that integrates organotypic tissue slice cultures, optical clearing, and high-resolution fluorescence imaging.

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What researchers measure

Primary outcomes

  1. response rate

    Time frame: through study completion, an average of 1 year"

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Study locations

1 site
  • China medical university hospital
    Taichung, 40401, Taiwan
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References and documents

Study documents

  • Study protocol · Jul 4, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Icf

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07468422
Lead sponsor
China Medical University Hospital
Collaborators
China Medical University, Taiwan
Responsible party
Ching Yun Hsieh (Attending physician, China Medical University Hospital) — Principal investigator
First posted
Mar 12, 2026
Start date
Oct 27, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Mar 12, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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