Biliary Tract Cancer
Conditions
Interventions
Group 1:Irinotecan Liposomal Injection (II) + 5-FU/LV
Group 2:Sequential therapy with nab-paclitaxel/S-1 followed by liposomal irinotecan/5-FU/LV.
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary participation with written informed consent obtained; 2.Aged between 18 and 75 years (inclusive), regardless of gender; 3.ECOG Performance Status of 0 ; 4.Histologically or cytologically confirmed advanced, metastatic, or recurrent biliary tract malignancy, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma; 5.At least one measurable lesion according to RECIST v1.1. Previously irradiated lesions can only be considered target lesions if they have demonstrated clear progression post-radiation and are the only measurable disease site; 6.Disease progression after or intolerance to one prior line of systemic therapy for advanced disease; 7.Life expectancy of >= 3 months; 8.Adequate function of major organs, without transfusion or use of hematopoietic growth factors within 14 days prior to enrollment; Neutrophil count >= 1.5 × 10^9/L; white blood cell count >= 3.0 × 10^9/L; platelet count >= 100 × 10^9/L; hemoglobin >= 90 g/L; albumin >= 30 g/L; total bilirubin = 50 ml/min; INR = 50%; 9.For women of childbearing potential: a negative serum pregnancy test within 72 hours before the first dose, not lactating, and willingness to use highly effective contraception throughout the treatment period and for 6 months after the last dose. Male subjects with female partners of childbearing potential must agree to use effective contraception during the same period.
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity to any component of the study drugs, their analogues, or excipients; 2.Prior treatment with irinotecan (or its liposomal formulation), nab-paclitaxel, S-1, or 5-FU/LV; 3.3. Apart from hair loss and fatigue, other toxicities caused by previous anti-tumor treatments had not recovered to CTCAE 5.0 Grade 1); 5.History of gastrointestinal perforation, fistula, intra-abdominal abscess, or non-gastrointestinal fistula (e.g., tracheoesophageal fistula) within 6 months prior to enrollment; 6.Concurrent or history of other malignancies, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix; 7.Significant bleeding history, including any Grade >= 3 bleeding event within 4 weeks prior to screening, or Grade >= 3 gastrointestinal bleeding within 6 months prior to enrollment; Presence of hemorrhagic gastrointestinal diseases or conditions deemed by the investigator to predispose to bleeding, perforation, or obstruction; 8.Interstitial lung disease, pneumoconiosis, radiation pneumonitis, active tuberculosis, active pneumonia, or severely impaired pulmonary function; 9.Uncontrolled third-space fluid accumulation (e.g., massive pleural effusion), except for stable ascites (requiring no intervention after drainage removal) within 4 weeks prior to enrollment; 10.Active or uncontrolled severe infection (CTCAE v5.0 >= Grade 2) and/or requirement for antibiotic therapy within 2 weeks prior to enrollment; 11.Concomitant use of strong inhibitors or inducers of CYP3A4/CYP2C8, or strong inhibitors of UGT1A1 within 2 weeks prior to enrollment; 12.Treatment with any other investigational agent or participation in another interventional clinical trial within 4 weeks prior to enrollment; 13.Arterial/venous thrombotic events within 24 weeks prior to signing the ICF, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage), deep venous thrombosis, or pulmonary embolism; 14.Known central nervous system metastases or a history thereof. For patients with clinical suspicion of CNS metastasis, a contrast-enhanced CT or MRI must be performed within 28 days prior to randomization to rule it out; 15.Other severe, uncontrolled comorbid conditions (e.g., severe intellectual or cognitive dysfunction; severe heart failure, angina, myocardial infarction, or significant arrhythmia); 16.Known peripheral neuropathy >= Grade 3 per CTCAE v5.0; 17.Any other condition deemed by the investigator as likely to necessitate premature study termination, including non-adherence, other severe illnesses (including psychiatric) requiring concomitant therapy, clinically significant laboratory abnormalities, or social/familial factors that could compromise patient safety or data integrity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;6/9/12 months PFS rate;Objective response rate, ORR;Disease control rate;Duration of Response;Incidence of adverse events (AE) and serious adverse events (SAE); | — |
Countries
China
Contacts
Public ContactGuangyu Wang
Harbin Medical University Cancer Hospital
Outcome results
None listed