Advanced biliary tract cancer
Conditions
Interventions
Experimental group:atilizumab and bevacizumab combined with GEMOX chemotherapy
Sponsors
The Third Affiliated Hospital of the Second Military Medical University of the Chinese people's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years old; 2. Sign the informed consent; 3. The investigator believes that the patient has the ability to comply with the research protocol; 4. Histologically or cytologically diagnosed as stage IV biliary tract malignant tumor, and the pathological type is adenocarcinoma. Biliary malignancies include gallbladder cancer, intrahepatic cholangiocarcinoma, and hilar cholangiocarcinoma; 5. The disease is not suitable for surgical treatment; 6. Have not received any anti-tumor therapy in the past 12 months; 7. At least 1 measurable (measurable according to RECIST1.1), untreated lesions; 8. Pre-treatment tumor tissue samples (if available). If tumor tissue is available, submit 1 formalin-fixed, paraffin-embedded (FFPE) tumor sample in a paraffin block (preferred), or approximately 10-15 slides containing unstained, freshly cut, serial sections Films, together with a relevant pathology report within 4 weeks of enrollment. If the FFPE samples described above are not available, any type of sample (including fine needle aspiration biopsy samples, cell mass samples [eg, from pleural effusions], and lavage samples) is acceptable. A relevant pathology report should be provided with the sample. If tumor tissue is not available (e.g., exhausted due to previous diagnostic testing), the patient is still eligible to participate in the study; 9. The ECOG performance status score within 7 days before enrollment is 0 or 1; 10. Adequate hematology and organ function, based on the following laboratory test results obtained within 7 days prior to enrollment (unless otherwise stated): (1) Absolute neutrophil count (ANC)>=1.5x10^9/L (1500/µL); (2) Platelet count >=100x10^9/L (75,000/µL), no blood transfusion; (3) Hemoglobin >= 90 g/L (9 g/dL); AST, ALT and alkaline phosphatase (ALP) = 60 mL/min (calculated using the Cockcroft-Gault formula); (5) Serum albumin>=28 g/L (2.8 g/dL); (6) Patients not receiving anticoagulation therapy: INR or aPTT =2+ proteinuria, 24-hour urine should be collected, and then it must be confirmed that the urine protein content within 24 hours is less than 1 g; (9) Cardiac color Doppler: left ventricular ejection fraction (LVEF) >= 50%. 11. Women of childbearing age must have a negative pregnancy test (ßHCG) before starting treatment, and women of childbearing age and men (having sex with women of childbearing age) must agree to use uninterrupted during treatment and for 6 months after the last therapeutic dose to be effective contraceptive measures; 12. Life expectancy greater than 3 months.
Exclusion criteria
Exclusion criteria: 1. Have a contraindication, history of hypersensitivity, or intolerance to any of the drugs used in the study; 2. Insufficient drainage of biliary obstruction, total bilirubin > 42.75µmol/L; 3. A history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months before starting study treatment; 4. Peripheral neuropathy of grade 2 or above (assessed by NCI CTCAE 4.03 criteria); 5. Blood pressure > 150/100 mmHg; 6. Major cardiovascular disease within 6 months prior to initiation of study treatment (such as New York Heart Association class II or more severe heart disease, myocardial infarction, or cerebrovascular accident within 6 months prior to initiation of study treatment), unstable Arrhythmia, unstable angina or coronary heart disease; 7. Received major surgery (except for diagnosis) within 4 weeks before the start of the study treatment or is expected to undergo major surgery during the study period; 8. There are serious wounds, ulcers or fractures that cannot be healed; 9. Known active infection, HIV positive; 10. Known evidence of bleeding diathesis or coagulation disorder; 11. Current or past autoimmune disease or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sj?gren's syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions: patients with prior autoimmune-related hypothyroidism receiving thyroid hormone replacement therapy are eligible for study participation; patients receiving insulin therapy Patients with controlled type 1 diabetes were eligible for study participation; only patients with dermatologically manifested eczema, psoriasis, chronic lichen simplex, or vitiligo (eg, excluding patients with psoriatic arthritis), provided All of the following conditions are eligible to participate in the study: (1) The rash area must be less than 10% of the body surface area; (2) Good disease control at baseline, requiring only low-efficiency topical glucocorticoid therapy; (3) In the past 12 months, the original condition did not require psoralen plus A-band ultraviolet radiation, methotrexate, vitamin A acid, biological agents, oral calcineurin inhibitors or high-efficiency or Acute exacerbations of oral glucocorticoid therapy. 12. Previous allogeneic stem cell or solid organ transplantation; 13. Received a live attenuated vaccine within 4 weeks before starting study treatment, or is expected to receive such a vaccine during atezolizumab treatment or within 5 months after the last dose of atezolizumab; 14. Malignant tumors other than biliary tract malignancies within 5 years prior to screening, except for malignancies with negligible risk of metastasis or death (eg, 5-year OS rate >90%), such as adequately treated in situ cervical cancer carcinoma, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer; 15. Central nervous system (CNS) metastases; 16. The patient cannot receive follow-up or is participating in other clinical trials; 17. Subjects deemed unsuitable for inclusion in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Progression-free survival;Time to progression;Duration of response; | — |
Countries
China
Contacts
Public ContactKang Wang
The Third Affiliated Hospital of the Second Military Medical University of the Chinese people's Liberation Army
Outcome results
None listed