Advanced malignant biliary tract tumors, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer
Conditions
Interventions
Arm 1:Irinotecan liposome (II) + Lenvatinib + Fluorouracil + Calcium Leucovorin
Arm 2:Irinotecan liposome (II) + Fluorouracil + Calcium Leucovorin
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily joins this study and signs the informed consent form. 2. Age: >=18 years old, regardless of gender. 3. Histologically or cytologically confirmed advanced malignant biliary tract tumors, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer. Previous failure of first-line combination therapy. 4. Previous failure of first-line combination therapy. 5. Presence of at least one measurable lesion (according to RECIST v1.1 criteria, the measurable lesion must have a spiral CT scan diameter >=10 mm or a short axis of enlarged lymph nodes >=15 mm; lesions previously treated with local therapy can be considered target lesions if they have clearly progressed according to RECIST v1.1 criteria). 6. ECOG PS: 0–1. 7. Life expectancy >=12 weeks. 8. Normal function of major organs, meeting the following requirements (within 14 days before the start of study treatment): (1) Hematological tests (no blood transfusion, no use of granulocyte colony-stimulating factor [G-CSF], and no correction with medication within 14 days before screening): Hemoglobin [HB] >=90 g/L. Absolute neutrophil count [ANC] >=1.5×10^9/L. Platelets [PLT] >=80×10^9/L. (2) Biochemical blood tests must meet the following criteria (no albumin infusion within 14 days before screening): Serum total bilirubin [BIL] 50 ml/min (Cockcroft-Gault formula): For males: Cr clearance rate = ((140 - age) × weight) / (72 × serum Cr). For females: Cr clearance rate = ((140 - age) × weight) / (72 × serum Cr) × 0.85. Weight unit: kg; serum Cr unit: mg/mL. (3) International Normalized Ratio [INR] <=2.3 or prothrombin time [PT] exceeding the normal control range by <=6 seconds. (4) Urine protein <2+ (if urine protein =2+, a 24-hour urine protein quantification can be performed, and patients with 24-hour urine protein quantification <1.0 g can be enrolled). 9. Fertile female participants must have a negative pregnancy test (serum or urine) within 7 days before the first administration of the drug, must not be breastfeeding, and must voluntarily use effective contraception during the study and for 6 months after the last administration of chemotherapy. For male participants with female partners of childbearing potential, they must be surgically sterilized or agree to use effective contraception during the study and for 3 months after the last administration of chemotherapy. Sperm donation is not allowed during the study period. 10. Participants with good expected compliance, able to follow the protocol requirements for follow-up visits to assess efficacy and adverse reactions.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with irinotecan, 5-FU, and anti-angiogenic drugs. 2. Presence of other active malignancies within 5 years or concurrently, except for biliary tract cancer (BTC). Patients with localized tumors that have been cured, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ, are eligible for enrollment. 3. Presence of uncontrolled cardiac symptoms or diseases, such as: (1) New York Heart Association (NYHA) Class II or higher heart failure or echocardiogram showing left ventricular ejection fraction (LVEF) 450 ms (male); QTc > 470 ms (female) (QTc interval calculated using the Fridericia formula; if QTc is abnormal, three consecutive measurements can be taken at 2-minute intervals, and the average value can be used). 4. Presence of hypertension that cannot be controlled to within the normal range with antihypertensive medications (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg) (based on the average of >=2 blood pressure readings). Patients who can achieve the above parameters through antihypertensive treatment are allowed; history of hypertensive crisis or hypertensive encephalopathy. 5. Any clinically significant gastrointestinal disease, including bleeding, inflammation, obstruction, or diarrhea > Grade 2. 6. Thrombotic or embolic events within 6 months before the start of study treatment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc. 7. Use of strong CYP3A4/CYP2C19 inducers, including rifampin (and its analogs) and St. John's wort, or strong CYP3A4/CYP2C19 inhibitors and/or strong UGT1A inhibitors within 14 days before signing the informed consent form. 8. Known allergy to irinotecan liposome injection, other liposomal irinotecan formulations, irinotecan, lenvatinib, or any of their excipients, fluoropyrimidines, or leucovorin. Presence of uncontrollable infection at the time of screening. 9. Patients with congenital or acquired immune deficiency (e.g., HIV-infected individuals). 10. History of brain metastasis or presence of brain metastasis. 11. Pregnant women or those planning to become pregnant during the study treatment period. 12. Other patients deemed unsuitable for inclusion by the treating physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Safety;Disease Control Rate;Objective response rate; | — |
Countries
China
Contacts
Public ContactAipingZhou
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed