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

March 9, 2026 updated by: Ching Yun Hsieh, China Medical University Hospital

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:

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40401
        • China Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The patients will receive treatments in CMUH.

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
response rate
Time Frame: through study completion, an average of 1 year"
through study completion, an average of 1 year"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Collaborators

China Medical University, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 22, 2025

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH114-REC1-159

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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