Intrahepatic Cholangiocarcinoma
Conditions
Interventions
Trial group:Eto combination antibody: 5 mg/kg, q3w
GEMOX regimen: Oxaliplatin 85 mg/m^2, q3w
Gemcitabine: 1000 mg/m^2 on days 1 and 8, q3w
Lenvatinib: 8 mg per dose (body weight =60 kg), oral, once daily
After 6 cycles of Eto combination antibody combined with GEMOX, patients proceed to maintenance therapy with Eto combination antibody combined with lenvatinib, continuing until disease progression or
subsequent lines of therapy shall be selected by the investigator based on real-world clinical practice.
Sponsors
Tianjin Third Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Understand and voluntarily sign the informed consent form for this study; 2. Age >= 18 years, gender not restricted; 3. Histologically or cytologically confirmed unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma; 4. No prior systemic therapy; neoadjuvant or adjuvant chemotherapy completed >= 6 months before diagnosis of unresectable or metastatic disease is permitted; 5. ECOG performance status 0–1; 6. Expected survival >= 3 months; 7. At least one measurable target lesion confirmed by imaging during the screening period according to RECIST v1.1 criteria; 8. Adequate organ and bone marrow function within 7 days prior to first study drug administration (no blood components or growth factors permitted within 14 days prior to enrollment): (1) Hemoglobin >= 90 g/L; (2) White blood cell count >= 3.5 × 10^9/L; (3) Absolute neutrophil count >= 1.5 × 10^9/L; (4) Platelet count >= 80 × 10^9/L; (5) AST, ALT = 50 mL/min); (8) Left ventricular ejection fraction (LVEF) >= 50%; (9) Fridericia-corrected QT interval (QTcF) < 470 ms; 9. Sexually active patients of childbearing potential must agree to use reliable contraception with their partner during the trial and for at least 180 days after the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1.Unable to comply with the study protocol or research procedures. 2.Presence of evidence of brain metastases. 3.Has previously received postoperative adjuvant therapy with immune checkpoint inhibitors or targeted agents directed against fibroblast growth factor (FGF) and its receptors, or vascular endothelial growth factor (VEGF) or its receptor (VEGFR). 4.Individuals who are allergic or have a hypersensitivity to the study drug or any of its formulation components. 5.Presence of active tuberculosis, radiation pneumonitis, drug-induced pneumonitis, or other diseases, symptoms, or signs indicating severe pulmonary impairment during the screening period. 6.Presence of severe cardiovascular or cerebrovascular diseases. 7.Received broad-spectrum antibiotic therapy via any route of administration within 30 days prior to the first dose. 8.Has evidence of significant bleeding tendency or other major coagulation disorders. 9.Currently presenting with interstitial pneumonia or interstitial lung disease, or having a prior history of interstitial pneumonia or interstitial lung disease requiring hormone therapy, or other pulmonary conditions such as pulmonary fibrosis or organizing pneumonia that may interfere with the assessment and management of immune-related pulmonary toxicity. 10.Presence of clinically symptomatic moderate or severe ascites requiring therapeutic paracentesis or drainage (excluding cases with only minimal ascites shown on imaging without clinical symptoms), or uncontrolled or moderate-to-large pleural effusion or pericardial effusion. 11.Has received systemic corticosteroid therapy or other immunosuppressants within 14 days prior to the first dose, or immunostimulants (including but not limited to interferon or interleukin-2, etc.) within 4 weeks. 12.Has had other malignancies within the 5 years prior to enrollment, except for curatively resected cutaneous basal cell or squamous cell carcinoma, or carcinoma in situ of the cervix. 13.Has active autoimmune disease or a history of autoimmune disease within 4 weeks prior to enrollment. 14.Patients whom the investigator considers unsuitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Quality of life score;Overall survival;Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs); proportion of patients with dose adjustments or discontinuation due to adverse events.; | — |
Countries
China
Contacts
Public ContactLou Cheng
Tianjin Third Central Hospital
Outcome results
None listed