Overview

Clinical Study on the efficacy and safety of hepatic arterial perfusion chemotherapy and Renvastinib combined with Adebrelimab neoadjuvant therapy for resection of high-risk biliary tract carcinoma.

Eligibility

Inclusion Criteria:

1. The patient must sign the informed consent;
2. Age 18-75 years old, male and female;
3. ECOG Physical status Score (PS score) 0 or 1;
4. Patients with BTC confirmed by pathological diagnosis (histopathology and/or cytology) or clinical diagnosis (with high risk factors);

   Risk factors are defined as follows:

   Stage ≥Ib, single lesion > 5cm, multiple tumor lesions in the same lobe, technically resectable;Vascular invasion, regional lymph node metastasis, technically resectable

5. Patients with untreated and resectable locally advanced BTC who have been assessed by the surgeon as surgically resectable;

   The details are as follows:

   Patients with intrahepatic cholangiocarcinoma had the clinical stage of T1b-4NanyM0 according to the 8th edition of AJCC, and the clinical stage of IB-IIIB according to the 8th edition of AJCC.Hilar cholangiocarcinoma, according to the 8th edition of AJCC clinical stage was T2-3N0-1M0, IIA-IIIA stage;The clinical stage of distal cholangiocarcinoma was T2-3N0-2M0, IIA-IIIA according to the 8th edition of AJCC.The clinical stages of patients with gallbladder cancer according to the 8th edition of AJCC were T2-3N0-1M0, and the clinical stages were IIA-IIIB.

6. The functional indicators of vital organs meet the following requirements

   ① Neutrophils ≥1.5109/L; Platelet ≥80109/L; Hemoglobin ≥9g/dl; Serum albumin ≥3g/dl;② Thyroid stimulating hormone (TSH) ≤ 1 times the upper limit of normal, T3, T4 in the normal range;③ Bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST≤ 2 times the upper limit of normal value;④ Serum creatinine ≤ 1.5 times the upper limit of normal value, creatinine clearance ≥60 ml/min;

7. The subject has at least one measurable lesion (according to RECIST1.1);
8. Fertile women: must agree to abstain from sex (abstain from heterosexual intercourse) or use a reliable, effective method of contraception for at least 120 days from the signing of the informed consent until the final administration of the study drug. Serum HCG test must be negative within 72 hours before randomization. And must be non-lactating.A woman is considered fertile if she has menstruated, has not yet reached postmenopausal status (no continuous periods for ≥12 months, no cause other than menopause has been found), and has not undergone sterilization (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).
9. For male subjects whose partner is a fertile woman, they must agree to abstain from sex or use a reliable, effective method of contraception for at least 120 days from the signing of the informed consent until the final administration of the study drug. Male subjects also had to agree not to donate sperm during the same time period. Male subjects with a pregnant partner are required to use condoms and do not need to use other methods of contraception.

Exclusion Criteria:

1. Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma and other non-cholangiocarcinoma malignant tumor components;
2. Prior systemic therapy and tumor-related surgical treatment (biliary drainage allowed);
3. Previous or co-existing malignancies other than adequately treated non-melanin skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma;
4. Active pulmonary tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year prior to enrollment; Had a history of active tuberculosis infection more than 1 year before enrollment, had not received formal anti-tuberculosis therapy or had active tuberculosis;
5. Have an active, known, or suspected autoimmune disease. Subjects with hypothyroidism requiring hormone replacement therapy and skin conditions that do not require systemic therapy are eligible;
6. Long-term acceptance of systemic sex hormones (doses equivalent to > 10mg prednisone per day) or any other form of immunosuppressive therapy. Participants using inhaled or topical corticosteroids may be enrolled;
7. severe cardiopulmonary and renal dysfunction;
8. Have hypertension that is not well controlled by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
9. Abnormal coagulation function (PT> 14s), have a tendency to bleed or are receiving thrombolytic or anticoagulant therapy;
10. HBV DNA> 2000IU/ml, HCV RNA> 1000 IU/ml;
11. Had clinically significant bleeding symptoms or a clear tendency to appear within 3 months before enrollment;
12. Active infections that require systemic treatment;
13. Human immunodeficiency virus (HIV, HIV1/2 antibodies) positive;
14. Have a history of psychotropic substance abuse, alcohol abuse or drug use;
15. Have a history of drug allergy;
16. Other factors, as determined by the investigator, that may affect the subject's safety or compliance with the test. Such as a serious illness (including mental illness) requiring co-treatment, serious laboratory abnormalities, or other family or social factors.