A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Adv… (NCT07099794) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Advanced Biliary System Tumors With Liposomal Irinotecan (II) Combination Regimen
China90 participantsStarted 2025-08-01
Plain-language summary
This is a randomized, two-cohort, multicenter Phase II clinical study. To evaluate the efficacy and safety of liposomal irinotecan II and 5-FU/LV combined with or without renvastinib in the treatment of patients with advanced biliary system tumors, 90 patients were scheduled to be enrolled.
Who can participate
Age range
18 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:
* The patients voluntarily joined the study and signed the informed consent;
* Histologically or cell line confirmed advanced biliary system malignancies, including intrahepatic, extrahepatic, and gallbladder cancers;
* Previous first-line combination therapy failed;
* At least one measurable lesion meets the RECIST v1.1 criteria
* ECOG PS：0\~1；
* Expected survival ≥12 weeks;
* Essential organ and hematological function;
* Patients need contraception;
Exclusion Criteria:
* The patient had previously received irinotecan, 5-Fu, and antiangiogenic agents;
* Patients had active malignancies other than BTC within 5 years or at the same time.
* Clinical symptoms or diseases of the heart that are not well controlled;
* Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
* Any clinically significant gastrointestinal disorder, including bleeding, inflammation, occlusion, or diarrhea \> grade 2;
* A thrombotic or embolic event occurred within 6 months prior to the start of the study therapy;
* Use of strong CYP3A4/CYP2C19 inducers including rifampicin (and its analogiaries) and hypericum perforatum or strong CYP3A4/CYP2C19 inhibitors and/or strong UGT1A inhibitors within 14 days prior to signing the informed consent;
* Known allergy to the study drug;
* An uncontrolled infection occurs during screening;
* Patients with congenital or acquired imm…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Progression-free survival
Timeframe: 5 years
Trial details
NCT IDNCT07099794
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences