cholangiocarcinoma
Conditions
Interventions
Treatment group:Sindillimab in combination with androtinib and gemcitabine
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: Age: 18 ~ 75 years old, male and female 2: Potential resectable cholangiocarcinoma confirmed by histopathology or cytopathology 3: No previous chemotherapy, immunotherapy, or interventional radiation therapy (transarterial chemoembolization, transarterial embolization, transarterial infusion). Subjects with disease recurrence at least 6 months after the end of neoadjuvant or adjuvant therapy may participate in the study 4: ECOG PS score: 0-1 5: Predicted survival >= 12 weeks 6: Had full hematopoietic function when entering the study and on day 1 of week 1 before administration, Defined as a white blood cell count >= 2.0 x 10^9 /L and neutrophil absolute count >= 1.5 x 10^9 /L, lymphocyte count >= 0.5 x 10^9 /L, platelet count >= 100 x 10^9 /L, and hemoglobin (Hgb) >=9 g/dL. Subjects with prior blood transfusions may participate if their Hgb at entry is stable at least 9 g/dL 7: Adequate liver function, i.e. total bilirubin level = 50 mL/ min estimated from the Cockcroft-Gault formula or from CCr tests using 24 hours of urine collected samples 9: Prothrombin time or activated partial prothrombin time and international normalized ratio <= 1.5 times ULN 10: Child-Pugh liver function rating A or good B (<=7 points) 11: Women of reproductive age should consent to the use of contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and for six months after the study ends. A non-lactating patient must have had a negative serum or pregnancy test within 7 days prior to study enrollment.Men should consent to patients who must use birth control during the study period and for six months after the study ends 12: The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up 13: Patients that researchers believe could benefit.
Exclusion criteria
Exclusion criteria: 1. Past and/or interrecurrent cancers. Exceptions include cancers that have been cured and have not recurred for more than 3 years, or early stage cancers that have been treated with curable treatment, including but not limited to cervical carcinoma in situ, superficial, non-invasive bladder cancer, basal cell carcinoma, squamous cell carcinoma in situ, or gastrointestinal tumors confined to the mucosal layer that have been resected endoscopically 2. Patients with a past or current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severe impairment of lung function that may interfere with the detection and management of suspected drug-related pulmonary toxicity 3. Patients with active tuberculosis or a history of active tuberculosis infection within 48 weeks or less before screening, regardless of treatment 4. Third space effusion with clinical symptoms requires repeated drainage, such as pericardial effusion, pleural effusion, and abdominal effusion that cannot be controlled by pumping or other treatment 5. Patients with brain metastases with central nervous system symptoms 6. Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation 7. Received systemic immune stimulants within 4 weeks prior to initial administration 8. Confirmed allergy to sindillimab, anrotinib, gemcitabine and/or their excipients 9. The presence of any active, known, or suspected autoimmune disease 10. Patients who received antitumor vaccine or other immunomodulatory drugs (e.g., interleukin-2, thymosin, lentinan, etc.) within 1 month prior to enrollment, or who will receive live attenuated vaccine 11. Participants who had been systematically treated with corticosteroids (>10 mg/ day of prednisone or equivalent hormones) or other immunosuppressive agents within 2 weeks prior to enrollment. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal hormone replacement therapy at doses 450 ms) and/or pacemaker implantation, or New York Heart Association Class III or IV congestive heart failure/or ventricular arrhythmia, or left ejection fraction <50% 16. Received any other clinical trial treatment within 28 days prior to enrollment 17. Active infections or unexplained fever
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate ,ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival rate;Progression-Free-Survival;Surgical conversion rate; | — |
Countries
China
Contacts
Public ContactTao Peng
Guangxi Medical University
Outcome results
None listed