gallbladder cancer and cholangiocarcinoma
Conditions
Interventions
Experimental group:Irinotecan liposome (II), 5-fluorouracil/calcium folinate combined with immunosuppressant + radiotherapy
Sponsors
Xiangyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years old, male or female; 2. Unresectable or metastatic gallbladder and cholangiocarcinoma confirmed by histopathology or cytology; 3. Have not previously received any systemic chemotherapy, immunotherapy, targeted therapy or local therapy for ICC (including but not limited to transarterial chemoembolization, intra-arterial embolization, intra-arterial chemoinfusion and radioactive particle embolization); Patients who received adjuvant chemotherapy after radical surgery and relapsed more than 6 months after the end of adjuvant chemotherapy could be enrolled. 4.There is at least one measurable lesion at baseline that meets the definition of RECIST1.1 standard; 5. Liver function Child-Pugh grade A (5-6 points) or better B grade (=12 weeks; 8.The functions of vital organs meet the following requirements (no blood components, cell growth factors, whitening drugs, platelet enhancing drugs, anemia correction drugs, etc., are allowed within 14 days before the first use of the investigational drug); a) Absolute neutrophil count (ANC>=1.5×10) *9/L; b) Platelet >=75×10*9/L; c) Hemoglobin >=90g/L; d) Serum albumin >=30g/L; e) Total bilirubin 60mL/min; g) Activated partial thromboplastin time (APTT) and international Normalized ratio (INR) <=1.5 × ULN (for stable dose anticoagulant therapy such as low molecular weight heparin or warfarin and INR can be screened within the intended therapeutic range of anticoagulants); 9.Women of childbearing age must undergo a negative pregnancy test (serum or urine) within 7 days prior to enrollment and voluntarily use an appropriate method of contraception during the observation period and 8 weeks after the last dose of the study drug; For men, they should be surgically sterilized or agree to use an appropriate method of contraception during the observation period and 12 weeks after the last administration of the study drug; 10. Subjects voluntarily join the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous systemic anticancer therapy for inoperable and/or metastatic disease; 2. The investigators determined that liver metastases accounted for 50% or more of the total liver volume; 3. Ascites requiring drainage or diuretic treatment, or pleural or pericardial effusion requiring drainage and/or symptoms of shortness of breath prior to the initial study of drug therapy; 4. Presence of grade 3 or 4 peripheral neuropathy; 5. Previously received liver transplantation; 6. Active brain metastases or spinal cord compression; 7. Uncontrolled systemic infections (viral, bacterial and fungal); 8. Allergic to irinotecan liposome, other liposome products, oxaliplatin, 5-fluorouracil, calcium folinate or any component of the above products in the past; 9. Received any investigational drug within 4 weeks prior to first use of the investigational drug; 10. Receiving the last dose of anticancer therapy (including radiotherapy, etc.) within 4 weeks before the first use of the investigational drug; 11. Major surgery within 4 weeks prior to first use of the study drug; 12. Enrolling in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up; 13. The subject has cardiovascular clinical symptoms or diseases that are not well controlled, including but not limited to: (1) NYHA class II or above heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; 14. The subjects had active hepatitis B (HBV DNA>= 2000IU/mL 104copies/mL), hepatitis C (hepatitis C antibody positive, or HCV-RNA higher than the lower detection limit of the analytical method); 15. Have been diagnosed with any other malignancies within 5 years prior to the first use of the investigational drug, except malignancies with a low risk of metastasis and death (5-year survival > 90%), such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ; 16. Pregnant or lactating women; 17. In the investigator's judgment, the subject has other factors that may lead to the forced termination of the study, such as other serious illnesses (including mental illness) requiring combined treatment, family or social factors that may affect the subject's safety or the collection of research data; 18. Other factors deemed unsuitable for participation in the study by the investigator.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Remission Rate; | — |
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Countries
China
Contacts
Public ContactGong Wei
Xiangyang Central Hospital
Outcome results
None listed