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Study design: Prospective, single-arm, single-center study; Primary endpoint: Safety; Secondary endpoints: Disease control rate, overall response rate, conversion rate, overall survival; Main characteristics of enrolled patients: Patients with initially unresectable biliary tract cancer; Interventions: Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab; Sample size: 10 patients;
Treatment until:
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 |
|---|---|---|---|
| experimental group | Experimental | Combination of Gemox, Donafenib and Tislelizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab | Combination Product | Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab every 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate | Disease control rate | 6 weeks |
| Overall response rate | Overall response rate | 6 weeks |
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Inclusion Criteria:
Routine blood tests: Hemoglobin ≥90 g/L (no blood transfusion within 14 days); Neutrophil count ≥1.5×10^9/L; Platelet count ≥80×10^9/L; Biochemical examination: Total bilirubin ≤2×ULN (upper normal value); ALT or AST ≤ 2.5×ULN; Endogenous creatinine clearance ≥ 50 mL /min (Cockcroft-Gault formula); 6. Sign the informed consent voluntarily; 9. Good compliance, and family members willing to cooperate with follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Wang, M.D. | Contact | +86-18121299357 | w.lr@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lu Wang, M.D. | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | 200032 | China |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| C000710249 | donafenib |
| C000707970 | tislelizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| Conversion rate | Conversion rate | 6 weeks |
| Overall survival | Overall survival | 6 weeks |