Phase 2 Study of Systemic Therapy With or Without Liver-Directed Radiation for Advanced Intrahepatic Cholangiocarcinoma
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT06858735
This clinical trial is comparing the effects of standard systemic therapy alone versus with added liver-directed radiation therapy in patients with advanced intrahepatic cholangiocarcinoma, a type of liver cancer.
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Program Overview
The study aims to see if adding liver-directed radiation therapy to the usual systemic treatment can improve survival in patients with advanced intrahepatic cholangiocarcinoma (iCCA). Researchers will also look at patients' quality of life, how long they live without the cancer getting worse, and the causes of death.
Description
The main goal of this study is to find out if patients with advanced intrahepatic cholangiocarcinoma live longer when they receive standard systemic therapy with or without additional liver-directed radiation therapy. Researchers will also assess patients' quality of life, how long they live without the cancer progressing, and the causes of death.
Participants will be adults with advanced iCCA who have not had surgery to remove the cancer. They will have received 4 to 8 cycles of chemotherapy with gemcitabine, cisplatin, and durvalumab. The study will include regular assessments to monitor the cancer and the patients' health.
The study will also evaluate the safety and effectiveness of the treatment, and participants will be required to attend scheduled visits and follow-up appointments.
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older.
- Body weight over 30 kg.
- Diagnosed with intrahepatic cholangiocarcinoma with at least one liver tumor 3 cm or larger.
- Cancer that cannot be surgically removed or has spread outside the liver.
- Completed 4 to 8 cycles of chemotherapy with gemcitabine, cisplatin, and durvalumab.
- Suitable for radiation therapy with good liver function.
- Life expectancy of at least 12 weeks.
- At least one measurable tumor that has not been treated with radiation.
- Able to provide informed consent and comply with study requirements.
Exclusion Criteria
- Participating in another clinical trial with an investigational product in the last month.
- Unresolved side effects from previous cancer treatments, except for hair loss and certain lab values.
- Receiving other cancer treatments not listed in the inclusion criteria.
- Major surgery within 28 days before starting the study treatment.
- History of organ transplant.
- Active autoimmune or inflammatory disorders, except for certain stable conditions.
- Uncontrolled illnesses or infections.
- History of another cancer, except for certain treated cancers with no active disease.
- Brain metastases or certain heart conditions.
- Active hepatitis or HIV infection not well controlled.
- Recent use of immunosuppressive medication or live vaccines.
- Pregnant or breastfeeding women, or those not using effective birth control.
- Allergy to study drugs or their components.
- Previous treatment with certain immunotherapy drugs that led to severe side effects.
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