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

NCT07468422 | Active Not Recruiting

• 1 other identifier: CMUH114-REC1-159
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer Patients With Solid Tumors; Cancer (Advanced Stage)

Outcome Measures

Primary Outcomes (1)

• response rate

  through study completion, an average of 1 year"

Interventions

OPTin: Organotypic Platform for Therapeutic Investigation OTHER

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients will receive treatments in CMUH.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• China Medical University, Taiwan: collaborator
• China Medical University Hospital: lead

Study Sites (1)

China medical university hospital

Taichung, 40401, Taiwan

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: March 12, 2026
• Study Start: October 27, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 12, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

TW (1)