Biliary Tract Cancer (BTC)
Conditions
Brief 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.
Interventions
DRUGLiposomal irinotecan+5-FU/LV+Lenvatinib
Liposomal irinotecan II: calculated as free base, 56.5 mg/m2, IV, d1q2w Renvastinib: ≥60kg, 12mg; \<60kg, 8mg, PO, once daily 5-FU: 1200 mg/ (m2·d) x2d continuous intravenous infusion for 46-48h, q2w LV: 400 mg/m2 intravenously, d1 q2w
DRUGNALIRI
Liposomal irinotecan II: calculated as free base, 56.5 mg/m2, IV, d1q2w 5-FU: 1200 mg/ (m2·d) x2d continuous intravenous infusion for 46-48h, q2w LV: 400 mg/m2 intravenously, d1 q2w
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 immune deficiency (e.g., HIV); * Have a history of brain metastases or have developed brain metastases;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 5 years | The time between participant randomization and first recorded disease progression or death from any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years | Patients were randomized to the time of death from any cause. |
| Objective Response Rate | 5 years | The proportion of participants in the analyzed population with confirmed complete (CR) or partial response (PR) based on RECIST v1.1 |
| Disease control rate | 5 years | Percentage of cases with confirmed complete response, partial response, and stable disease (≥ 8 weeks) in patients for whom response could be evaluated. |
| Adverse events | 5 years | Adverse events (AE)/Serious Adverse Events (SAE) (as determined by NCI-CTCAE 5.0). |
Countries
China
Contacts
Primary ContactWen Zhang, Doctor
Outcome results
None listed