Advanced Biliary Tumors
Conditions
Interventions
single arm:Anlotinib Hydrochloride Combined with Sintilimab
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; both male and female. 2. According to RECIST v1.1, there is at least one measurable lesion in gallbladder cancer or intrahepatic and extrahepatic cholangiocarcinoma confirmed by histopathology. Tissue samples should be provided for biomarker analysis, and newly acquired tissues should be selected for optimal selection. Patients with newly acquired tissues can not provide 5-8 paraffin sections of 5 um thickness that can be archived and preserved. 3. Patients with distant metastasis or locally advanced stage can not receive surgery or radiotherapy. During or after first-line chemotherapy, there are imaging evidence (such as CT scan) or clinical evidence (such as new cytological reports of ascites or pleural effusion) to prove the progress of the disease. Subjects need to receive at least one dose of first-line treatment, which allows one drug to be discontinued, reduced or fluorouracils. For neoadjuvant or adjuvant therapy (chemotherapy or chemoradiotherapy), if the disease progresses during treatment or within 6 months after treatment, it should be counted as first-line treatment. 4. ECOG score 0-1. 5. The life expectancy is more than 12 weeks. 6. No antiangiogenic drugs other than bevacizumab have been used. 7. The function of the main organs is normal, which meets the following criteria: (1) Blood routine examination: HB > 90 g/L; (No blood transfusion within 14 days) B. ANC (>1.5*10^9L); C. PLT (> 80 *10^9/L); (2) Biochemical examination: A. ALB > 30g/L; (No ALB was transfused within 14 days); B. ALT and AST 60ml/min; 8. Doppler echocardiography: left ventricular ejection fraction (LVEF) > low normal value (50%). 9. Subjects volunteered to participate in the study, signed informed consent, and were able to comply with the program requirements of visits and related procedures. 10. Female subjects of childbearing age or male subjects whose sexual partners are women of childbearing age need to take effective contraceptive measures during the whole treatment period and 6 months of treatment period.
Exclusion criteria
Exclusion criteria: 1. Allergies to antinil hydrochloride and/or its excipients, as well as to the constituents of Sindelimab have been confirmed. 2. Patients with uncontrollable hypertension (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg), coronary heart disease above grade I, arrhythmia of grade I (including prolonged QTc interval in males > 450 ms, females > 470 ms) and cardiac insufficiency of grade I; patients with positive urinary protein. 3. Patients with a definite tendency of gastrointestinal bleeding, including local active ulcer lesions, and fecal occult blood (++) can not be included in the group; patients with a history of melena and hematemesis within 2 months. 4. Coagulation dysfunction (INR > 1.5, APTT > 1.5 ULN), with a tendency to bleed. 5. There are many factors affecting oral drug absorption (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction). 6. Patients with central nervous system metastasis. 7. Pregnant or lactating women. 8. Patients with other malignant tumors within 5 years (excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix). 9. Patients with a history of psychotropic substance abuse who cannot be withdrawn or who have mental disorders. 10. Patients who participated in other drug clinical trials within 4 weeks. 11. Received treatment with inhibitors of vascular endothelial growth factor R, such as sorafenib, sunitinib, and apatinib. 12. Patients without healing wounds or fractures. 13. Patients with abnormal thyroid function. 14. Urinary protein (++) or 24-hour urinary protein quantification greater than 1.0 g. 15. Target lesions received radiotherapy within 4 weeks prior to the first dose of the study. 16. Immunosuppressive drugs were used within 4 weeks prior to the first dose of the study, excluding local glucocorticoids or systemic glucocorticoids (i.e. no more than 10 mg/prednisone or other glucocorticoids of equivalent dose) through nasal spray, inhalation or other routes. 17. Acceptance of live attenuated vaccine within 4 weeks before the first dose of treatment or during the study period is planned. 18. Major surgical procedures (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures were performed within 4 weeks prior to the first dose of treatment. 19. Toxicity (excluding alopecia, non-clinical significance and asymptomatic laboratory abnormalities) that did not return to level 0 or 1 of NCI CTCAE 4.03 (NCI CTCAE 4.03) prior to the first dose of research therapy was present. 20. Symptomatic central nervous system metastases and/or cancerous meningitis are known. Subjects who had previously received brain metastasis therapy participation in the study is provided that brain metastases remain stable for at least four weeks before the first dose of treatment, and neurological symptoms must be restored to NCI CTCAE 4.03 version 0 or 1. 21. Active, known or suspected autoimmune diseases or a history of the disease over the past two years (vitiligo, psoriasis, alopecia or Graves disease that do not require systematic treatment within the past two years, hypothyroidism requiring only thyroid hormone replacement therapy, and type I diabetes patients requiring insulin replacement therapy alone can be enrolled in the group). 22. Uncontrolled complications include, but are not limited to, people living with HIV (HIV-positive). Severe infections that are active or clinically poorly controlled. 23. Sy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Countries
China
Contacts
Public ContactHong Zong
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed