Biliary malignant tumor, BTC
Conditions
Interventions
Experimental group:Systematic chemotherapy
Sponsors
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign an informed consent form. 2. Age range from 18 to 75 years old, suitable for both men and women. 3. Subjects diagnosed with BTC (including gallbladder cancer, intrahepatic cholangiocarcinoma (ICCA), hilar cholangiocarcinoma, and extrahepatic cholangiocarcinoma) through pathological histology/cytology and who cannot be surgically removed. 4. TNM staging: Stage IIIA to Stage IV; 5. At least one measurable lesion (according to RECIST 1.1, the spiral CT scan length of the measurable lesion should be = 10mm or the short diameter of the enlarged lymph node should be = 15mm); 6. Child Pugh liver function rating within 7 days prior to enrollment: A or B (= 7 points). 7. ECOG PS score within 7 days prior to enrollment: 0-1 . 8. Failure to receive local or systemic anti-tumor treatment for BTC prior to initial administration. 9. Expected survival time = 12 weeks. 10. The main organ functions meet the following requirements (within 7 days before enrollment): (1) Blood routine examination: (excluding hemoglobin, no blood transfusion within 14 days prior to screening, no use of granulocyte colony-stimulating factor [G-CSF], no medication correction): Neutrophil count = 1.5 × 10 ^ 9/L; Platelets = 75 × 10 ^ 9/L; Hemoglobin = 90g/L. (Leukocyte and thrombocytopenia caused by splenic hyperfunction can be included in the study after partial embolization of the splenic artery or medication correction) (2) Blood biochemistry test (no albumin transfusion within 14 days before screening): Serum albumin = 28g/L; Total serum bilirubin = 1.5 × ULN; ALT and AST = 3 × ULN; Blood creatinine = 1.5 x ULN or Cr clearance rate>50ml/min. 11. Women with fertility: must agree to contraception from the time of signing the informed consent form until 90 days after the last use of the study drug. And the blood HCG test must be negative within 7 days before starting the study treatment; And it must be non lactation period. 12. If a female subject has already menstruated, has not yet reached a postmenopausal state, and has not undergone sterilization surgery (such as hysterectomy, bilateral tubal ligation/resection, or bilateral oophorectomy), it is considered that the subject has fertility. 13. For male participants whose partners are women with fertility, they must agree to abstain from sexual activity or use reliable and effective methods of contraception from the time of signing the informed consent form until 90 days after the last use of the study drug (whichever is longer). Male participants must also agree not to donate sperm during the same time period. Male participants whose partners are pregnant must use condoms and do not need to use other contraceptive methods.
Exclusion criteria
Exclusion criteria: 1. Within 5 years or simultaneously suffering from other active malignant tumors other than BTC. Cured local tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, can be included in the group. 2. Participants who are preparing to undergo or have previously received organ or allogeneic bone marrow transplantation. 3. Subjects who are currently accompanied by interstitial pneumonia or interstitial lung disease, or have a history of interstitial pneumonia or interstitial lung disease that requires hormone therapy in the past, or other pulmonary fibrosis, organized pneumonia (such as bronchiolitis obliterans), pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or those with evidence of active pneumonia or severe lung function impairment seen on chest computed tomography (CT) images during screening, are allowed to have radiation induced pneumonia in the radiation field; Active tuberculosis. 4. Currently, there is active autoimmune disease or a history of autoimmune disease that may recur (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects that can be controlled only through hormone replacement therapy can be included]); Subjects with skin diseases that do not need systematic treatment, such as vitiligo, psoriasis, alopecia, controlled type I diabetes that receive insulin treatment, or childhood asthma that has completely alleviated without any intervention after adulthood can be included; Asthma subjects who require medical intervention with bronchodilators cannot be included. 5. Moderate to severe ascites with clinical symptoms that require therapeutic puncture, drainage, or Child Pugh score>2 (excluding those with only a small amount of ascites on imaging but no clinical symptoms); Uncontrolled or moderate to equal amounts of pleural effusion and pericardial effusion. 6. There are clinical symptoms or diseases of the heart that cannot be well controlled, such as: (1) According to the standards of the New York Heart Association (NYHA) (see Annex 4) Grade II or above cardiac insufficiency or cardiac ultrasound examination: LVEF (left ventricular ejection fraction)480ms (QTc interval is calculated using the Fridericia formula; if QTc is abnormal, it can be detected continuously three times every 2 minutes, and the average value is taken). 7. Previous or current central nervous system metastasis. 8. Subjects with congenital or acquired immune dysfunction (such as HIV infected individuals). 9. There is evidence to suggest the presence of intra-abdominal gas that cannot be explained by puncture or recent surgical procedures. 10. Severe, unhealed or cracked wounds, as well as active ulcers or untreated fractures. 11. Received major surgical treatment within 4 weeks prior to the start of the study (excluding diagnosis) or expected to undergo major surgical treatment during the study period. 12. Severe infection within 4 weeks prior to the start of the study treatment, including but not limited to hospitalization due to complications of in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Objective response rate ,ORR;Disease control rate, DCR; | — |
Countries
China
Contacts
Public ContactShen Rong
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Outcome results
None listed