A Clinical Study of TQB3454 Tablets in the Treatment of Advanced Biliary Carcinoma.

Inclusion Criteria:

• age ≥18 years old, ≤75 years old (calculated on the date of signing the informedconsent); Eastern Cooperative oncology Group (ECOG) score 0 ~ 2.

• Tumor tissue samples must be provided for genetic testing (10 puncture paraffinsections or 5 surgical paraffin sections).

• Patients with viral hepatitis: Patients should be treated symptomatically until thevirus is stable before enrollment, and treatment should be maintained during theexperimental period.

• The main organs have good functions.

• Meet the criteria for advanced biliary carcinoma:

1. cholangiocarcinoma histologically or cytologically confirmed

2. Locally advanced, relapsing, and/or metastatic disease that is not operable andhas at least one measurable lesion according to Response Evaluation Criteria InSolid Tumors V1.1 (RECIST 1.1) criteria.

3. Previous gemcitabine and fluorouracil (and/or platinum-based) drug therapyfailed.

• Women of reproductive age should agree that they must use effective contraceptionduring the study period and for 6 months after the study, and that serum or urinepregnancy tests are negative within 7 days prior to study enrollment; Men shouldagree that effective birth control must be used during the study period and for sixmonths after the end of the study period.

• The subjects voluntarily joined the study, signed the informed consent, and thecompliance was good.

Exclusion Criteria:

• Complicated diseases and medical history.

1. The patient had or was currently present with other malignant tumors within 3years prior to the first medication.

2. Unmitigated toxic reactions above class 1 of Common Terminology Criteria forAdverse Events V5.0 (CTCAE) due to any previous treatment, excluding hair loss;

3. Received major surgical treatment, significant traumatic injury, orlong-standing unhealed wounds or fractures within 4 weeks prior to initialmedication;

4. Patients with any bleeding or bleeding events ≥CTCAE grade 3 within 4 weeksprior to initial administration; Patients with arteriovenous thrombotic events,such as cerebrovascular accidents (including transient ischemic attacks), deepvein thrombosis and pulmonary embolism, occurring within 6 months prior toinitial administration; Treatment with low molecular weight heparin was allowedand antiplatelet drugs were prohibited throughout the study;

5. There is a history of active tuberculosis, idiopathic pulmonary fibrosis,institutional pneumonia, drug-induced pneumonia, radiation pneumonia requiringtreatment or active pneumonia with clinical symptoms;

6. Those who have the history of psychotropic drug abuse and cannot abstain orhave mental disorders;

7. Those who plan to undergo or have previously received allogeneic bone marrowtransplantation or solid organ transplantation;

8. A history of hepatic encephalopathy;

9. Current or recent use (within 7 days prior to the start of study treatment) ofaspirin (>325 mg/ day (maximum antiplatelet dose) or dipyridamole, ticlopidine,clopidogrel, and cilostazol;

10. Subjects with any severe and/or uncontrolled medical conditions, including:

11. Poor blood pressure control (systolic blood pressure ≥150 mmHg ordiastolic blood pressure ≥100 mmHg);

12. have grade 2 myocardial ischemia or myocardial infarction, arrhythmias (including Corrected Q-T interval (QTC) ≥ 450ms in men and 470ms inwomen), and grade 2 congestive heart failure (New York Heart Association (NYHA) rating);

13. Active or uncontrolled severe infection (≥CTCAE grade 2 infection);

14. Patients with renal failure requiring hemodialysis or peritoneal dialysis;

15. A history of immunodeficiency, including HIV positive or other acquired orcongenital immunodeficiency diseases;

16. People who have epilepsy and need treatment.

• Tumor related and treatment:

1. Hepatocellular carcinoma, fibrolamellar hepatocellular carcinoma, sarcomatoidhepatocellular carcinoma, etc. confirmed by histology or cytology;

2. According to imaging examination, cancer thrombus of the portal vein involvedboth the main trunk and the left and right primary branches, or involved boththe main trunk and above veins (superior mesenteric vein, inferior mesentericvein, spleen vein), or had cancer thrombus of the inferior vena cava orinvolved the heart;

3. Uncontrolled pleural effusion, pericardial effusion or moderate to severeascites that still require repeated drainage (the investigator's judgment);

4. Known spinal cord compression, cancerous meningitis, symptoms of brainmetastases, or symptoms controlled for less than 4 weeks.

• Research and treatment related:

1. Known allergy to study drug excipients.

2. Patients with multiple factors affecting oral medication (such as inability toswallow, chronic diarrhea and intestinal obstruction);

3. Patients who require immunosuppressive, systemic, or absorbable topical hormonetherapy for immunosuppressive purposes and who continue to use it within 7 daysprior to initial administration (except for those whose daily dose ofcorticosteroids is less than 10 mg prednisone or other therapeutic hormones).

• Patients who participated in and used other antitumor clinical trials within 4 weeksbefore the first drug administration;

• According to the judgment of the researcher, there is any situation that seriouslyendangers the safety of the subject or affects the completion of the study.