Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers (NCT03801083) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Biliary Tract Cancers
United States4 participantsStarted 2019-02-19
Plain-language summary
This is a Phase 2 study to evaluate the efficacy, using objective response rate, of a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous Tumor Infiltrating Lymphocytes (TIL) and high-dose aldesleukin in patients with locally advanced, recurrent, or metastatic biliary tract cancer. These are low-incidence cancers carry a poor prognosis. Participants will include patients with biliary tract cancers (BTC), including cholangiocarcinoma (both intrahepatic and extrahepatic) and gallbladder cancer, who are and are physically able to tolerate non-myeloablative chemotherapy and high-dose aldesleukin.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Measurable locally advanced, recurrent, or metastatic biliary tract carcinoma (including intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma).
* Patients with locally advanced disease should be unresectable by conventional surgical approaches.
* Patients with distant metastatic spread must be refractory to approved standard systemic therapies (such as gemcitabine, cisplatin, or equivalents) if they are eligible to receive these treatments.
* Patients must be co-enrolled on the companion protocol HCC 17-220 (Cell Harvest and Preparation to Support Adoptive Cell Therapy Clinical Protocols and Pre-Clinical Studies) and have available TIL cultures for therapy.
* Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.
* Greater than or equal to 18 years of age and less than or equal to age 75
* Able to understand and sign the Informed Consent Document
* Clinical performance status of ECOG 0 or 1
* Life expectancy of greater than three months
* Patients of both genders who are of child-bearing potential must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the treatment.
* Serology:
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses tumor infiltrating lymphocytes — cells taken from the tumor itself and grown in a lab before being infused back — how would my tumor actually be collected, and is that procedure safe given where my biliary tract cancer is located?
2Since this is a Phase 2 trial measuring how many patients see their tumors shrink or respond, what does the current evidence suggest about whether TIL therapy has shown meaningful responses in biliary tract or cholangiocarcinoma patients so far?
3The trial is active but no longer enrolling new patients — does that mean results might be available soon, and could those findings change what treatment options you'd recommend for me right now?
4Before considering an experimental approach like TIL therapy, are there standard treatments — such as chemotherapy, targeted therapy based on my tumor's genetic profile, or other immunotherapy — that I should try first, and how would that affect my eligibility if this trial were to reopen?
5TIL therapy typically involves chemotherapy to prepare the immune system before the cell infusion — how intensive is that process, and given my current health and support at home, is that level of treatment realistically manageable for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.