Advanced Biliary Tract Cancer
Conditions
Interventions
Single-arm:Atezolizumab 1200 mg intravenous infusion on day 1 + Gemcitabine 1000 mg/m^2 intravenous infusion on days 1 and 8 + Liposomal Irinotecan (Type II) 80 mg/m2 intravenous infusion on day 1, ev
Sponsors
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be enrolled in this study: 1.The patient voluntarily participates in this study and signs the informed consent form (ICF). 2.Age >= 18 years, male or female. 3.Histologically confirmed unresectable locally advanced or metastatic biliary tract malignancy, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer. 4.No prior systemic and/or locoregional therapy for biliary tract malignancy (including but not limited to transarterial chemoembolization, transarterial embolization, transarterial chemotherapy infusion, and radioactive seed implantation) is allowed; patients who relapsed > 6 months after completion of adjuvant therapy following curative surgery may be enrolled. 5.At least one measurable lesion (per RECIST v1.1: longest diameter on spiral CT >= 10 mm or short axis of enlarged lymph node >= 15 mm; lesions previously treated with local therapy may be selected as target lesions if unequivocal progression per RECIST v1.1 is documented). 6.Child-Pugh liver function classification: Class A. 7.ECOG performance status: 0-1. 8.Estimated life expectancy >= 12 weeks. 9.No prior use of any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints), including but not limited to anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibodies, including local administration of these agents. 10.Recovery from toxicities related to any prior treatment to = 1.5 x 10^9/L ?Platelets >= 100 x 10^9/L ?Hemoglobin >= 90 g/L 2) Blood biochemistry (no albumin infusion within 14 days prior to screening): ?Albumin >= 30 g/L ?Total bilirubin 50 mL/min 3) Coagulation: INR 2+, a 24-hour urine protein quantification is required; patients may be enrolled if 24-hour urine protein = 12 consecutive months of amenorrhea without other causes), and has not undergone steri
Exclusion criteria
Exclusion criteria: 1. The known pathological types are hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma of the liver and fibrolamellar cell carcinoma. 2. Having suffered from other active malignant tumors other than biliary tract malignant tumors within 5 years or at the same time; Cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, and carcinoma in situ of the breast, can be enrolled. 3. Those with a history of hepatic encephalopathy. 4. There has been or is currently central nervous system metastasis and/or meningeal metastasis. 5. Other investigational drugs were received within 28 days prior to the start of the study treatment. 6. Moderate to severe ascites with clinical symptoms, that is, those requiring therapeutic puncture or drainage, or those with a Child Pugh score >2 (except for those with only a small amount of ascites shown on imaging but without clinical symptoms); Uncontrolled or moderate to excessive pleural effusion and pericardial effusion. 7. There was a history of gastrointestinal bleeding or a clear tendency of gastrointestinal bleeding within 6 months before the start of the study treatment, such as: Those with a risk of bleeding or severe esophageal and gastric fundus varices, those with local active peptic ulcer lesions, and those with persistent positive fecal occult blood were not eligible for enrollment. (If fecal occult blood is positive during the baseline period, re-examination is required. If it remains positive after re-examination, gastroscopy is needed. If gastroscopy indicates a risk of bleeding for esophageal and gastric fundus varices, enrollment is not allowed.) 8. Known hereditary or acquired bleeding (such as coagulation disorders) or thrombotic tendencies, such as in hemophilia patients; Currently, or recently (within 10 days before the start of the study treatment), full-dose oral or injectable anticoagulant drugs or thrombolytic drugs have been used for therapeutic purposes (prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed). 9. The study shows that thrombosis or embolism events occurred within 6 months prior to the start of treatment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc. 10. There are poorly controlled clinical symptoms or diseases of the heart, such as: (1) According to the New York Heart Association (NYHA) criteria (see attachment), grade II or above cardiac insufficiency or echocardiography examination: LVEF (left ventricular ejection fraction) 450ms (male); QTc>470ms (for females) (The QTc interval is calculated using the Fridericia formula; if QTc is abnormal, three consecutive tests can be conducted at intervals of 2 minutes, and the average value is taken). 11. Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg); (Based on the average of BP readings obtained from =2 measurements), the above parameters can be achieved through the us
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Overall Survival (OS);Safety Outcomes (including: overall incidence of treatment-emergent adverse events, adverse events related to study drug, serious adverse events, dose modifications/interruptions/discontinuations due to adverse events, laboratory abnormalities, vital sign abnormalities, electrocardiogram abnormalities); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Duration of Response (DoR);Progression-Free Survival (PFS); | — |
Countries
China
Contacts
Public ContactXiao Zhiyu
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Outcome results
None listed