Tumors of the biliary system can be resected
Conditions
Interventions
Experimental group:Cisplatin + gemcitabine + Adebrelimab + Apatinib mesylate tablets + surgical resection
Sponsors
Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) The subject 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) BTC subjects who have been pathologically diagnosed (histopathological and/or cytological); Agree to provide previously stored tumor tissue specimens or fresh biopsy tumor lesions; 5) No previous systematic treatment; 6) Functional indicators of vital organs meet the following requirements a) Neutrophils =1.5*10^9/L; Platelet =80*10^9/L; Hemoglobin =9g/dl; Serum albumin =3g/dL; b) Thyroid stimulating hormone (TSH) = 1 times the upper limit of normal, T3, T4 in the normal range; c) Bilirubin = 1.5 times the upper limit of normal value; ALT and AST= 2 times the upper limit of normal value; d) Serum creatinine = 1.5 times the upper limit of normal, creatinine clearance =60 ml/min; 7) The subject has at least one measurable lesion (according to RECIST v1.1); 8) Subjects have at least one of the following high-risk relapse risk factors: a) Positive lymph nodes; b) invasion of large blood vessels; c) R0 can not be resected because of intrhepatic vascular or biliary tract structure; d) For intrahepatic cholangiocarcinoma, the tumor is multi-focal or the tumor is diaphragmatic; e)CA199 > 100U/mL; f) Primary tumor > 3cm; 9) 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 10) A woman is considered fertile if she has menstruated, has not yet reached postmenopausal status (no period of continuous menstruation for =12 months, no cause other than menopause is found), and has not undergone sterilization (such as hysterectomy, bilateral tubal ligation, or bilateral oophorectomy). 11) 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
Exclusion criteria: 1) Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma and other non-cholangiocarcinoma malignant tumor components; 2) Subjects who have previously received PD-1 antibody, PDL-1 antibody or CTLA4 antibody therapy; 3) Previous or co-existing malignancies other than adequately treated non-melanin skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma; 4) Active tuberculosis infection. Participants 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 systemic sex hormone (dose equivalent to >10mg prednisone/day) or any other form of immunosuppressive therapy is required. Participants using inhaled or topical corticosteroids may be enrolled; 7) Severe cardiopulmonary and renal dysfunction; 8) Have high blood pressure that is not well controlled by antihypertensive medication (systolic blood pressure =140mmHg or diastolic blood pressure =90mmHg); 9) Abnormal coagulation function (PT>14s), bleeding tendency or receiving thrombolytic or anticoagulant therapy; 10) Subjects with HBV DNA>2000IU/mL and HCV RNA>1000 IU/mL; 11) There were 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) History of platinum allergy; 16) Other factors, as determined by the investigator, that may affect subjects' 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathologic complete response, PCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Main pathological remission, MPR;objective response rate, ORR;Overall survival, OS;relapse-free survival, RFS;R0/R1 removal rate; | — |
Countries
China
Contacts
Public ContactHu Xin Duan/Chuang Peng
Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University)
Outcome results
None listed