Biliary tract cancer
Conditions
Interventions
Wxperimental group:Liposomal irinotecan combination with Gemcitabine, cisplatin, and Camrelizumab
Sponsors
Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–80 years, male or female; 2. Histologically confirmed unresectable gallbladder cancer and intra- or extrahepatic cholangiocarcinoma; 3. No prior systemic anticancer therapy (including chemotherapy, interventional therapy, PVE, immunotherapy, targeted therapy, etc.); 4. ECOG PS: 0–1; 5. Life expectancy > 3 months; 6. Normal major organ function meeting the following criteria (within 7 days prior to study treatment initiation): (1) Hemoglobin [HB] >= 90 g/L; (2) Absolute neutrophil count [ANC] >= 1.5 × 10^9/L;(3) Platelets [PLT] >= 100 × 10^9/L; (4) Serum total bilirubin [TBIL] 50 mL/min (Cockcroft-Gault formula); 7. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and voluntarily agree to use an appropriate method of contraception during the observation period and for 8 weeks after the last study drug administration. For males, this means surgical sterilization or agreement to use an appropriate method of contraception during the observation period and for 8 weeks after the last study drug administration; 8. Good compliance is anticipated, enabling adherence to protocol requirements for follow-up on efficacy and adverse reactions; 9. Informed consent form signed.
Exclusion criteria
Exclusion criteria: 1. Have other active malignant tumors within 5 years or concurrently; 2. Uncontrolled cardiac clinical symptoms or disease, such as: (1) Class II or higher cardiac insufficiency according to the New York Heart Association (NYHA) criteria or cardiac ultrasound: LVEF (Left Ventricular Ejection Fraction) 450 ms (men); QTc >470 ms (women) (QTc intervals were calculated using the Fridericia formula; if the QTc was abnormal, three consecutive measurements were taken at approximately 2-minute intervals, and the average value was taken); (6) cardiac spectrophotometric enzyme assays of LDH >240 IU/L; AST >40 IU/L; CK-MB >25 IU LDH>240IU/L; AST>40IU/L; CK-MB>25IU/L; a-HBDH>250IU/L. 3. Those with hypertension that cannot be reduced to the normal range (systolic BP >= 140 mmHg or diastolic BP = 90 mmHg) with antihypertensive medication (based on the average of BP readings obtained from = 2 measurements) are permitted to achieve the above parameters with the use of antihypertensive therapy; 4. patients with signs or history of bleeding, regardless of severity; any bleeding or bleeding event CTCAE grade 3 within 4 weeks prior to enrollment, unhealed wounds, ulcers, or fractures; 5. Abnormal coagulation function (INR>1.5×ULN, APTT>1.5×ULN), with bleeding tendency; 6. Routine urinalysis showing urinary protein++, confirming 24-hour urine protein quantification >1.0g; 7. severe diarrhea; 8. Presence of active autoimmune disease or history of autoimmune disease with potential for relapse; 9. known history of severe allergy to the study drug; 10. uncontrolled infection or unexplained fever >38.5°C at screening; 11. other patients deemed unsuitable for inclusion by the treating physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Overall survival;Progression-free survival; | — |
Countries
China
Contacts
Public ContactLiu Houbao
Shanghai Xuhui Central Hospital
Outcome results
None listed