intrahepatic cholangiocarcinoma, ICC
Conditions
Interventions
A:Toripalimab+capecitabine
Sponsors
The Third Affiliated Hospital of Naval Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Histopathologically confirmed intrahepatic cholangiocarcinoma; consent to provide previously stored tumor tissue specimens or fresh biopsy tumor lesions; 2.TNM: TanyN0M0; 3.R0 resection; 4.Aged 18-75 years, male or female; 5.ECOG:0-1; 6.Non-lactating or pregnant women, contraception during or after 3 months of treatment 7.The patient must be required to sign an informed consent form; 8.Functional indicators of vital organs meet the following requirements a Neutrophils 1.5*109/L; platelets >= 100*10^9/L; hemoglobin >= 9g/dl; serum albumin >= 3g/dl; b Thyroid stimulating hormone (TSH) = 60ml/min.
Exclusion criteria
Exclusion criteria: 1.Pathological diagnosis of other cholangiocarcinoma malignant tumor components; 2.Patients who have received previous treatment with PD1 antibody, programmed death ligand -1 (PDL1) antibody or cytotoxic T lymphocyte-associated antigen-4 (CTLA4) antibody; 3.With other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma; 4.Active tuberculosis infection. Patients with active tuberculosis infection within 1 year prior to enrollment; had a history of active tuberculosis infection more than 1 year before enrollment, did not receive formal anti-tuberculosis treatment or tuberculosis is still active; 5.Have an active, known or suspected autoimmune disease. Subjects who require only hormone replacement therapy for hypothyroidism and skin diseases that do not require systemic therapy may be enrolled; 6.Previous interstitial lung disease, or (non-infectious) pneumonia and need oral or intravenous steroid therapy; 7.Long-term systemic hormones (dose equivalent to >10 mg prednisone/day) or any other form of immunosuppressive therapy are required. Subjects using inhaled or topical corticosteroids may be enrolled; 8.Severe cardiopulmonary and renal dysfunction; 9.Suffering from high blood pressure, and can not be well controlled by antihypertensive drugs (systolic blood pressure >=140mmHg or diastolic blood pressure >= 90mmHg); 10.Abnormal blood coagulation (PT>14s), with bleeding tendency or receiving thrombolytic or anticoagulant therapy; 11.Hepatitis B virus (HBV) DNA > 2000 copies/ml, hepatitis C virus (HCV) RNA > 1000; 12.Significant clinically significant bleeding symptoms or a clear tendency to appear within 3 months prior to enrollment; 13.Active infections requiring systemic treatment; 14.Human immunodeficiency virus (HIV) positive; 15.History of psychotropic substance abuse, alcohol abuse or drug abuse; 16.Other factors that may influence the safety of the subject or the compliance of the test by the investigator. Serious illnesses (including mental illness), severe laboratory tests, or other family or social factors that require combined treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RPS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;Adverse events; | — |
Countries
China
Contacts
Public ContactBinghua Dai
The Third Affiliated Hospital of Naval Military Medical University
Outcome results
None listed