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Study design: Prospective, single-arm, single-center phase II clinical study; Primary endpoint: Conversion rate; Secondary endpoints: Safety, disease control rate, disease-free survival, and overall survival; Main characteristics of enrolled patients: Patients with initially unresectable biliary tract cancer; Interventions: Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab; Sample size: 34 patients; Treatment until: 1. successfully conversed to resectable disease 2. progressed disease 3. intolerable toxicity 4. patient requests withdrawal; Research process: In this study, patients who met the inclusion criteria were evaluated at the end of every 3 weeks of treatment, up to surgical treatment or disease progression; Safety evaluation: Evaluate adverse reactions according to CTCAE 4.0; Follow up: 12 months after the last case was enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combined treatment group | Experimental | Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab Gemcitabine: 1000mg/m^2, iv, d1, d8, q3w Oxaliplatin: 100mg/m^2, iv, d1, q3w Sintilimab: 200mg, iv, d1, q3w Bevacizumab: 5mg/kg, d1, q3w |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab | Drug | Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate | objective response rate | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety:the incidence of adverse events and serious adverse events | Incidence of adverse events and serious adverse events | 3 weeks |
| disease control rate | disease control rate |
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Inclusion Criteria:
Age ≥18 and ≤80 years;
ECOG 0~1;
Histologically or cytologically confirmed carcinoma of the bile duct or gallbladder;
Imaging assessment of disease stage III/IVA/any TN1M0*;
The main organs have good functions and the examination indexes meet the following requirements:
Blood routine test:
Hemoglobin ≥90 g/L (no blood transfusion within 14 days); Neutrophils count ≥1.5×10^9/L; Platelet count ≥80×10^9/L;
Biochemical tests:
Total bilirubin ≤2×ULN (upper limit of normal value); Blood alanine aminotransferase (ALT) or blood aspartate aminotransferase (AST) ≤ 2.5×ULN; Endogenous creatinine clearance rate ≥ 50 mL /min (Cockcroft-Gault formula);
Voluntarily signed the informed consent;
Good compliance and family members are willing to cooperate with follow-up.
Exclusion Criteria:
12. Concomitant diseases that, in the Investigator's judgment, seriously endanger patient safety or affect patient completion of the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| C000632826 | sintilimab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
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| 3 weeks |
| progress-free survival | progress-free survival | 3 weeks |
| overall survival | overall survival | 3 weeks |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |