Patients with advanced cholangiocarcinoma confirmed by histopathology and/or cytology
Conditions
Interventions
Trial group:Treatment regimen:
1. QL1706: 5 mg/kg, ivgtt, D1, Q3W
2. Gemcitabine: 1000 mg/m^2, ivgtt, D1, D8, Q3W
3. Nab-paclitaxel: 125 mg/m^2, ivgtt, D1, D8, Q3W
Enrolled patients will rece
Sponsors
Yunnan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years; 2.ECOG performance status score of 0-1; 3.Patients with advanced cholangiocarcinoma confirmed by histopathology and/or cytology; 4.At least one measurable lesion according to RECIST 1.1 criteria; 5.No prior systemic or local treatment for the tumor has been administered. 6.Sufficient organ and bone marrow function; 7.The subject fully understands the purpose, nature, and methods of the trial, as well as the potential adverse reactions that may occur. They voluntarily participate in this trial and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.History of other malignant tumors within the past 5 years; 2.Severe cardiovascular disease within 12 months prior to enrollment, such as symptomatic coronary artery disease, congestive heart failure = Class II, uncontrolled arrhythmia, myocardial infarction; 3.Uncontrollable pleural effusion, pericardial effusion, or ascites; 4.Use of steroids or other systemic immunosuppressive therapies within 4 weeks prior to enrollment; 5.HIV antibody positive, active hepatitis B or C (HBV, HCV); 6.History of known allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 7.Allergy or intolerance to the therapeutic drug or its components; 8.Pregnant or breastfeeding women; 9.Other circumstances deemed unsuitable for inclusion in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease Control Rate;Progression-free survival; | — |
Countries
China
Contacts
Public ContactXie Lin
Yunnan Cancer Hospital
Outcome results
None listed