Cholangiosarcoma Trials in Disease

Study of Trabectedin alone versus Trabectedin with tTF-NGR combination therapy in adults with metastatic or refractory soft tissue sarcoma who failed first-line treatment

This clinical trial is designed for patients with soft tissue sarcoma, including cholangiosarcoma, whose cancer has spread to other parts of the body or has not responded well to previous treatments. The study compares two different treatment approaches to determine which is more effective at controlling the disease.

Main inclusion criteria:

• Adults between 18 and 75 years of age
• Confirmed diagnosis of advanced or metastatic soft-tissue sarcoma that did not respond to previous treatment with anthracycline medications, or patients who cannot take anthracycline medications due to medical reasons
• High-grade soft tissue sarcoma (grade 2-3) of specific types, including liposarcoma, fibrosarcoma, leiomyosarcoma, rhabdomyosarcoma, angiosarcoma, synovial sarcoma, or undifferentiated sarcoma
• Tumor must test positive for CD13, a specific protein marker, with a score of 1 or higher
• At least one measurable tumor that has not been previously treated with radiation
• Life expectancy of at least 3 months
• Ability to carry out daily activities with an ECOG Performance Status of 2 or less
• Women who can become pregnant must have a negative pregnancy test and use effective birth control during the study and for 3 months after; men must use birth control methods for 5 months after the last treatment

Main exclusion criteria:

• Age below 18 or above 75 years
• No confirmed diagnosis of soft-tissue sarcoma or no previous treatment with anthracycline therapy
• Negative test result for CD13
• Current pregnancy or breastfeeding
• Previous treatment with trabectedin
• Severe heart, liver, or kidney problems
• Active uncontrolled infections or other active cancers requiring treatment
• Known allergic reactions to the study medications
• Participation in another clinical trial within the past 30 days

Focus and goal: The trial aims to determine if adding tTF-NGR to standard trabectedin treatment helps keep the cancer under control for a longer time compared to using trabectedin alone. Participants receive treatment for up to 360 days through intravenous infusion. The experimental drug tTF-NGR is designed to concentrate the chemotherapy medication inside the tumor, potentially making the treatment more effective. Regular medical examinations and imaging tests are performed throughout the study to monitor how the cancer responds to treatment. The study is expected to continue until March 2029.

Investigational drugs: The trial uses two medications:

• Trabectedin – A cancer medication that works by interfering with cancer cell growth and division. It is typically used when other treatments, particularly those containing anthracyclines, have not worked effectively.
• tTF-NGR – An experimental therapy designed to work together with trabectedin. It targets blood vessels in tumors and is intended to help trap the cancer medication inside the tumor, making the treatment more effective by keeping the medication concentrated where it is needed most.

Summary

Currently, there is only one ongoing clinical trial specifically related to cholangiosarcoma as part of soft tissue sarcoma treatment research. This trial is being conducted in Germany and focuses on patients whose cancer has either spread or has not responded to initial treatments. The study explores whether combining an experimental drug called tTF-NGR with the established chemotherapy medication trabectedin can provide better disease control than trabectedin alone. The trial requires patients to have tumors that test positive for the CD13 protein marker and focuses on providing treatment options for those who have exhausted first-line therapies. This research represents an important step in developing more effective treatment approaches for patients with advanced soft tissue sarcomas, including cholangiosarcoma.