Combining TATE and Pembrolizumab for advanced colorectal and lung cancer
An Open Label Phase II Study for the Treatment of Liver Metastatic Colorectal Cancer and Non-Small Cell Lung Cancer With a Combination of TATE (Trans-Arterial Tirapazamine Embolization) and Pembrolizumab
This study is testing if combining a new treatment called TATE with Pembrolizumab can help people with advanced colorectal cancer and lung cancer that has spread to the liver live longer and respond better to treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Teclison Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, Pembrolizumab |
| Locations | 3 sites (Orange, California and 2 other locations) |
| Trial ID | NCT04701476 on ClinicalTrials.gov |
What this trial studies
This open-label study aims to treat patients with refractory metastatic colorectal cancer (mCRC) and non-small cell lung cancer (NSCLC) with liver metastasis using Trans-arterial Tirapazamine Embolization (TATE) in combination with Pembrolizumab. Patients with mCRC will be randomized to receive either the combination treatment or standard care options, while all NSCLC patients will receive the combination treatment. The primary endpoints are Overall Survival (OS) for mCRC patients and Overall Response Rate (ORR) for NSCLC patients, allowing for a comparative analysis of treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates include patients with liver metastatic MSS-mCRC or NSCLC who have progressed on prior treatments and meet specific health criteria.
Not a fit: Patients with extensive liver metastasis, prior organ transplants, or certain health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new effective treatment option for patients with advanced colorectal and lung cancers that have not responded to previous therapies.
How similar studies have performed: While there have been studies exploring similar combinations, this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Liver metastatic MSS-mCRC or NSCLC without EGFR or AKT mutations * mCRC progressed on at least two lines of standard chemotherapy; or * NSCLC progressed on chemotherapy and an immune checkpoint inhibitor * Measurable disease * ECOG 0-1 * At least 4 weeks from prior chemotherapy and free from chemo-related toxicity * Adequate organ function Exclusion Criteria: * Prior organ transplantation * Liver metastasis more than 50% * Oxygen saturation less than 92% in room air * Prior autoimmune disorder * CNS metastasis * Major GI bleeding in the last 2 months
Where this trial is running
Orange, California and 2 other locations
- University of California, Irvine Medical Center — Orange, California, United States (Recruiting)
- China Medical University Hsinchu Hospital — Hsinchu, Taiwan (Recruiting)
- Chung Shan Medical University Hospital — Taichung, Taiwan (Recruiting)
Study contacts
- Study coordinator: Ray Lee, MD. PhD.
- Email: ray.lee01@teclison.com
- Phone: 8043341076
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.