Advanced Intrahepatic Cholangiocarcinoma
Conditions
Interventions
Trial group:Adebrelimab 1200 mg, intravenous, once every 3 weeks as one treatment cycle
Gemcitabine 1000 mg/m^2 and Cisplatin 25 mg/m^2, administered on Day 1 and Day 8, Q3W, for a maximum of 8 cycles.
Sponsors
Eastern Theater Command General Hospital of the People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the study and sign the informed consent form; 2. Age 18 to 75 years, either sex; 3. Histologically and/or cytologically confirmed diagnosis of unresectable advanced or metastatic intrahepatic cholangiocarcinoma; 4. No prior exposure to immunotherapy; 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1; 6. Adequate organ function as defined by the following criteria: absolute neutrophil count >=1.5×10^9/L; platelet count >=75×10^9/L; hemoglobin >=90 g/L; serum albumin >=30 g/L; creatinine clearance >=60 mL/min; thyroid-stimulating hormone (TSH) <=1 times the upper limit of normal, with normal serum T3 and T4 levels; women of childbearing potential must have a negative pregnancy test (ß-hCG) prior to initiation of treatment; women of childbearing potential and men (who have sexual relations with women of childbearing potential) must agree to use contraception during treatment and for 6 months after the last dose of therapy.
Exclusion criteria
Exclusion criteria: 1. History of other primary malignant tumors, except the following: a. Malignant tumors previously treated with curative intent and no known active disease for >=5 years prior to first dose, with low risk of recurrence; b. Adequately treated non-melanoma skin cancer or malignant lentigo maligna without evidence of disease; c. Adequately treated carcinoma in situ without evidence of disease. 2. Current interstitial pneumonia or interstitial lung disease, or history of interstitial pneumonia or interstitial lung disease requiring steroid treatment; or other pulmonary conditions that may interfere with assessment and management of immune-related pulmonary toxicity, such as pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or subjects with active pneumonia or severely impaired lung function demonstrated by chest CT during screening; active tuberculosis. 3. Active autoimmune disease or history of autoimmune disease with potential for recurrence [including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (subjects with hypothyroidism controlled solely by hormone replacement therapy may be enrolled)]; subjects with dermatologic conditions not requiring systemic therapy such as vitiligo, psoriasis, or alopecia; subjects with well-controlled type I diabetes mellitus requiring insulin therapy or childhood asthma fully resolved without intervention in adulthood may be enrolled; subjects requiring bronchodilator medical intervention for asthma are excluded. 4. Use of immunosuppressive agents or systemic steroids for immunosuppressive purposes within 2 weeks prior to first study treatment (dose >10 mg/day prednisone or equivalent). 5. Active infection; unexplained fever >=38.5°C within 1 week prior to first study treatment; or baseline white blood cell count >15×10^9/L; use of therapeutic oral or intravenous antibiotics within 2 weeks prior to first study treatment (prophylactic intravenous antibiotics administered for =3 deep vein thrombosis, or pulmonary embolism. 11. Poorly controlled cardiac symptoms or disease, including: (1) NYHA class II or higher heart failure or echocardiography showing LVEF (left ventricular ejection fraction) <50%; (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Overall Survival;Exploration of Biomarkers Affecting Clinical Efficacy; | — |
Countries
China
Contacts
Public ContactMei Kuimin
Eastern Theater Command General Hospital of the People's Liberation Army
Outcome results
None listed