A Study on Safety and Efficacy of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule in Patients With Advanced Biliary Adenocarcinoma/Hepatocellular Carcinoma

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• Patients who had previously received treatment with target inhibitors of vascular endothelial growth factor R, including Anlotinib hydrochloride capsules, or other anti-PD-1/PD-L1/CTLA-4 antibodies or other immunotherapy against PD-1/PD-L1/CTLA-4 were treated; 2、Severe hypersensitivity was observed after administration of other monoclonal antibodies; 3、Within five years, the subjects had other malignant tumors (except cured basal cell carcinoma of skin, carcinoma in situ of prostate and carcinoma in situ of cervix); 4、There is any active autoimmune disease or history of autoimmune disease (e.g., autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; asthma patients who need bronchiectasis for medical intervention can not be included); but the following patients are allowed to enter the group: vitiligo without systemic treatment, psoriasis, alopecia, well-controlled I. In type 2 diabetes mellitus, hypothyroidism with normal thyroid function is treated by substitution therapy; 5、Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage > 10mg/prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first administration; 6、Those with multiple factors affecting oral medication, such as inability to swallow, Post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc; 7、Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage; 8、Regardless of the severity, patients with any physical signs or history of bleeding, patients with bleeding or bleeding events greater than or equal to CTCAE 3 within four weeks prior to the first administration, or patients with unhealed wounds, fractures, gastric and duodenal active ulcers, ulcerative colitis, or unresected tumors have active bleeding, or may be caused as determined by the researchers. Other conditions of gastrointestinal bleeding and perforation;9、Brain metastases were detected by CT or MRI at screening, and there was a history of organ transplantation;10、Within four weeks before the start of the study, the patients received approved or in-progress antineoplastic therapy, including but not limited to chemotherapy, surgery, radiotherapy, biological targeted therapy, interventional therapy, immunotherapy and antineoplastic traditional Chinese medicine treatment (based on indications of Chinese medicine instructions, such as 2-week elution period can also be included in the group), etc. (Note: Oral targeting drugs with less than 5 half-lives or oral fluorouracil; Patients with pyridine drugs for less than 14 days, mitomycin C and nitrosourea for less than 6 weeks, and patients whose adverse events (except hair loss) caused by previous treatment did not recover to < CTCAE 1 degree;11、Patients with any serious and/or uncontrollable disease, including:(a) Patients with unsatisfactory blood pressure control (systolic blood pressure (> 150 mmHg), diastolic blood pressure (> 90 mmHg);(b) Thrombotic events, ischemic attacks, myocardial infarction, grade 2 congestive heart failure or arrhythmias requiring treatment (including QTc (> 480ms) occurred within 6 months of first administration;(C) Severe active or uncontrolled infections (> CTC AE 2 infection), tuberculosis patients;(D) Known clinical history of liver diseases, including viral hepatitis, known carriers of hepatitis B virus (HBV) must exclude active HBV infection, that is, HBV DNA positive (> 1 *104 copies/mL or > 2000 IU/mL); known hepatitis C virus infection (HCV) and HCV RNA positive (> 1 *103 copies/mL), or other decompensated hepatitis and chronic hepatitis, which require antiviral treatment. Therapy;(E) HIV positive;(F) poor control of diabetes mellitus (fasting blood sugar (> CTCAE 2);(G) Urinary routine indicated that urinary protein (++) and confirmed 24-hour urinary protein quantification (>1.0 g);12、Vaccinated with vaccines or attenuated vaccines within 4 weeks after first administration; 13、According to the judgement of the researchers, there are other factors that may lead to the termination of the study. For example, other serious diseases (including mental disorders) need to be treated together, there are serious abnormal laboratory examinations, accompanied by family or social factors, which will affect the safety of the subjects, or the collection of data and samples.