Cholangiocarcinoma
Conditions
Brief summary
The clinical trial is designed to evaluate the safety and efficacy of GEMOX combined with targeted therapy and immunotherapy for patients with advanced cholangiocarcinoma, and screen the potential biomarkers
Interventions
DRUGGEMOX Regimen
Oxaliplatin 100mg/m2 IV d1 Q3W+ gemcitabine 1000mg/m2 IV d1/8 Q3W
DRUGLenvatinib
8/12mg PO QD continuously
DRUGToripalimab
240mg IV d1 Q3W
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, 18 years old ≤ age ≤ 70 years old * ECOG PS scores 0-1 * Expected survival time \> 12 weeks * Advanced cholangiocarcinoma confirmed by histopathology and/or cytology, locally advanced (inoperable) or distant metastasis, and with at least one measurable lesion that has not been locally treated (per RECIST 1.1 criteria) * Not received any previous systemic or local treatment for the tumor * Sufficient organ and bone marrow function
Exclusion criteria
* Suffered from other malignant tumors in the past 5 years (except Radical basal cell carcinoma of the skin squamous carcinoma of the skin and/or radical resected carcinoma in situ) * Ampullary tumor * Received treatment from other clinical trials within 4 weeks before the first dose * Received any anti-PD-1 antibody, anti-PD-L1/L2 antibody, anti-CTLA4 antibody, or other immunotherapy * Suffered from severe cardiovascular disease within 12 months before enrollment, such as symptomatic coronary heart disease, congestive heart failure ≥ Grade II, uncontrolled arrhythmia, and myocardial infarction * Uncontrollable pleural effusion, pericardial effusion or ascites * Use steroids or other systemic immunosuppressive therapies 4 weeks before enrollment * Allergic reactions to the drugs used in this study * HIV antibody positive, active hepatitis B or C (HBV, HCV) * Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation * other conditions that the investigator deems inappropriate for enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | up to 90 days after last treatment administration | Overall response rate ( ORR) is defined as proportion of participants who have a best response of CR or PR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | up to 90 days after last treatment administration | Disease Control Rate (DCR) is defined as proportion of participants who have a best response of CR、PR or SD |
| Progression free survival (PFS) | up to 3 years | the time period from randomization of the participants to objective tumor progression or death |
| Overall survival (OS) | up to 3 years | the time period from the randomization of the participants to the death event due to any reason |
| The frequency, duration, and severity of adverse events | up to 30 days after last treatment administration | Safety is assessed by the frequency, duration, and severity of adverse events |
Countries
China
Contacts
Primary ContactWei Liu, MD
Backup ContactNingning Zhang, MD
Outcome results
None listed