Biliary tract cancer
Conditions
Interventions
Therapy group:HAIC+adebrelimab+lenvatinib
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 75 years old, no limit to male or female; 2. Biliary tract malignant tumors confirmed by histology or cytology, with measurable tumor lesions (spiral CT or MR scan =10mm, meeting RECIST 1.1 standards); 3. Borderline resectable, locally advanced biliary malignant tumors, including gallbladder cancer, intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, and distal cholangiocarcinoma; 4. Tumor TNM staging: gallbladder cancer stage: IIIA-IVB; intrahepatic cholangiocarcinoma stage: IIA-IV; hilar cholangiocarcinoma stage: IIIB-IVB; distal cholangiocarcinoma stage: IIIA-IV; 5. Expected survival > 3 months; 6. ECOG PS score: 0-1 points; 7. Liver function classification is Child-Pugh =7; 8. The patient has not received systemic treatment for biliary tract tumors in the past; 9. No peritoneal metastasis or other distant metastasis; Note: Whether there is distant metastasis should be confirmed by CT or MR scan. If bone metastases are suspected, a bone scan should be performed. If peritoneal metastasis is suspected, PET-CT examination or laparoscopy should be performed. If brain metastases are suspected, CT or MR examination should be performed. 10. The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors during the screening period): 1) Absolute neutrophil count =1.5×109/L; platelets =80×109/L; hemoglobin =8.5 g/dL; 2) Thyroid-stimulating hormone (TSH) =1 times ULN (if abnormal, T3 and T4 levels should be checked at the same time. If T3 and T4 levels are normal, you can be included in the group); 3) Bilirubin =3 times ULN; ALT and AST =5 times ULN; 4) Serum creatinine =1.5 times ULN. 11. Women of childbearing age must have a negative pregnancy test (ßHCG) before starting treatment, and women of childbearing age and men (who have sexual intercourse with women of childbearing age) must agree to use contraceptive measures uninterruptedly during treatment and for 6 months after the last therapeutic dose.; 12. Subjects voluntarily join the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with periampullary cancer; 2. Pregnant or lactating women, or those with childbearing potential but refuse to take contraceptive measures; 3. Have a history of other malignant tumors in the past 5 years, except for cervical carcinoma in situ or cutaneous squamous cell carcinoma that has been fully treated, or basal cell carcinoma of the skin that has been basically controlled; 4. Are receiving any of the following treatments: 1) Have received any investigational drugs within 4 weeks before the first use of investigational drugs; 2) Subjects who need to be given corticosteroids (>10 mg prednisone equivalent dose per day) or other immunosuppressants for systemic treatment within 2 weeks before using the study drug for the first time, except for treatment of local inflammation , prevention of allergies, and use of corticosteroids for nausea and vomiting. In the absence of active autoimmune disease, inhaled or topical steroids are allowed at a dose of >10 mg/d prednisone or an equivalent dose of corticosteroids; 3) Those who have received anti-tumor vaccines or have received live vaccines within 4 weeks before the first administration of study drugs; 5. Those with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction; 6. Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia and severely impaired lung function; 7. Suffering from active autoimmune diseases or a history of autoimmune diseases, such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Reduced thyroid function after thyroid hormone replacement therapy can be eligible. 8. Have a history of immunodeficiency, including testing positive for HIV, suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation; 9. Subjects have cardiovascular clinical symptoms or diseases that cannot be well controlled, including but not limited to: 1) NYHA class II or above heart failure; 2) Unstable angina; 3) Myocardial infarction within 1 year; 4) Clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; 10. Severe active infection requiring intravenous antibiotic treatment occurs during the screening period; 11. Those who are allergic to experimental drugs; 12. Patients who cannot comply with the trial protocol or cannot cooperate with follow-up visits; 13. Those who the researcher believes are not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate;Surgery conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;pathological complete response rate;Major pathological response rate;Relapse-free survival;Disease-free survival;Overall survival;Safety;Patient-reported outcomes;Explore tumor biomarkers; | — |
Countries
China
Contacts
Public ContactYubao Zhang
Harbin Medical University Cancer Hospital
Outcome results
None listed