Systemic Therapy + Radiation for Liver Cancer

Recruiting in Palo Alto (17 mi)

Overseen byEugene Koay, MD,PHD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This study will compare outcomes for M1 iCCA patients treated with and without L-RT by reviewing iCCA patients found to have M1 disease at initial diagnosis at a single institution between 2010 and 2021 who received L-RT.

Eligibility Criteria

This trial is for patients with advanced intrahepatic cholangiocarcinoma (a type of liver cancer) who have metastatic disease at initial diagnosis. Specific eligibility criteria are not provided, but typically include factors like age, overall health status, and having no prior treatments that would conflict with the trial.

Inclusion Criteria

My cancer is advanced and cannot be removed by surgery.

Patients must meet all inclusion and have no exclusion criteria to enroll and be randomized on the study if pre-registered before cycle 4 of systemic therapy

My organs and bone marrow are functioning well.

+9 more

Exclusion Criteria

Judgment by the treating physician that the patient is unsuitable to participate in the study and unlikely to comply with study procedures

Mean QT interval corrected for heart rate using Fridericia's formula ≥470 ms

Participation in another clinical study with an investigational product during the last 1 month

+18 more

Participant Groups

The study is testing the effectiveness of systemic therapy using Durvalumab combined with Gemcitabine and Cisplatin chemotherapy, comparing outcomes with or without additional liver-directed radiation therapy in patients.

2Treatment groups

Experimental Treatment

Group I: Standard of Care Arm - Durvalumab + Gemcitabine + CisplatinExperimental Treatment3 Interventions

Participants will receive treatment in sequence with standard of care systemic therapy

Group II: Experimental Arm - Liver-RT + DurvalumabExperimental Treatment1 Intervention

Participants will receive treatment in sequence with standard of care systemic therapy