Intrahepatic Cholangiocarcinoma (ICC),Extrahepatic Cholangiocarcinoma (ECC),Gallbladder Carcinoma (GBC)
Conditions
Interventions
experimental group:iparomlimab combined with Chemotherapy,?with or without SBRT
Sponsors
The affiliated hospital of southwest medical university
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age >=18 years and 6 months after curative resection; or > 6 months after completion of adjuvant therapy if adjuvant treatment was administered postoperatively; 4.Eastern Cooperative Oncology Group (ECOG) performance status 0–1; 5.No prior systemic anti-tumor therapy; 6.Life expectancy = 3 months; 7.At least one measurable or evaluable lesion according to RECIST v1.1; 8.Adequate organ function: (1)Hematology:1)Platelet count (PLT) >=80 × 10^9/L;2)Hemoglobin (Hb) >=90 g/L;3)Absolute neutrophil count (ANC) >=1.5 × 10^9/L (no hematopoietic growth factors within 14 days before first study treatment); (2)Blood chemistry:1)Total bilirubin (TBIL) =60 mL/min (Cockcroft-Gault formula);4)Serum albumin >=25 g/L (2.5 g/dL);5)International normalized ratio (INR) = lower limit of normal (>= 50%). 9.Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours before first study treatment, and agree to use effective contraception during the study and for 3 months after the last dose of Ato combination antibody. Male subjects with partners of childbearing potential must agree to use effective contraception during the study and for 3 months after the last dose of Ato combination antibody. 10.Voluntary participation in the study, signed informed consent, good compliance, and willingness to comply with follow-up procedures.
Exclusion criteria
Exclusion criteria: 1.Tumor-related symptoms and treatment: (1)Mixed histology including hepatocellular carcinoma, fibrolamellar carcinoma, sarcomatoid hepatocellular carcinoma, or ampullary carcinoma;(2) Presence of distant organ metastasis; (3)Prior treatment with PD-1, PD-L1, or CTLA-4 inhibitors. 2.Concomitant diseases/medical history: (1)Other active malignant tumor within 5 years before signing informed consent or synchronous malignancy, except malignancies with low risk of metastasis or death (5-year survival > 90%), such as adequately treated basal cell or squamous cell skin carcinoma, or carcinoma in situ of the uterine cervix; (2)Any active or history of autoimmune disease, including but not limited to: interstitial lung disease, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism (hypothyroidism may be allowed if controlled with hormone replacement).Patients with fully resolved psoriasis or childhood asthma/allergy requiring no intervention in adulthood may be included; patients requiring medical intervention with bronchodilators are excluded; (3)History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency, organ transplantation, or allogeneic bone marrow transplantation; (4)Uncontrolled cardiac conditions including but not limited to: NYHA class >= II heart failure, unstable angina, myocardial infarction within 1 year, clinically significant uncontrolled supraventricular or ventricular arrhythmia; (5)Severe infection (CTCAE grade > 2) within 4 weeks before first study treatment, including severe pneumonia, bacteremia, infectious complications requiring hospitalization;Signs or symptoms of infection or oral/intravenous antibiotics within 14 days before first study treatment (prophylactic antibiotics allowed); (6)Active tuberculosis documented by history or CT, or active tuberculosis within 1 year before enrollment, or history of active tuberculosis > 1 year without standard treatment; (7)Active hepatitis B (HBV DNA >= 2000 IU/mL or 104 copies/mL) or hepatitis C (HCV Ab positive with detectable HCV RNA). 3.Study treatment-related: (1)Received systemic immunostimulants (including but not limited to interferon, interleukin-2, or investigational immunostimulants) within 4 weeks before first dose; (2)Received systemic immunosuppressive therapy (including but not limited to corticosteroids, azathioprine, methotrexate, thalidomide, antiTNF agents) within 2 weeks before first dose.Nasal/inhaled corticosteroids or physiological doses of systemic steroids (<=10 mg/day prednisone or equivalent) are allowed; (3)Known hypersensitivity to any study drug or excipient, or severe hypersensitivity to other monoclonal antibodies. 4.Pregnant or lactating female subjects; female subjects of childbearing potential with positive pregnancy test at baseline or unwilling to use effective contraception throughout the study. 5.Documented history of neurological or psychiatric disorders including epilepsy or dementia; known history of psychoactive substance abuse, alcoholism, or drug addiction. 6.Any other condition deemed by the investigator to render the subject unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological Response,MPR;2-Year Overall Survival Rate;Disease Control Rate ,DCR;Conversion Resection Rate;R0 Resection Rate;Overall Survival,OS;Safety;Relapse-Free Survival ,RFS; | — |
Countries
China
Contacts
Public Contactyangxiaoli
The affiliated hospital of southwest medical university
Outcome results
None listed