Clinical trial · Interventional
GEMOX Combined With Donafenib and Tislelizumab in Biliary Tract Cancer
Safety and Efficacy of GEMOX Combined With Donafenib and Tislelizumab as First-line Treatment in Biliary Tract Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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: 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 2 circles of treatment (6 weeks), 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Carcinoma | Biliary Tract Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- experimental group
- description
- Combination of Gemox, Donafenib and Tislelizumab
- interventionNames
- Combination Product: Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab
Primary outcomes (1)
- measure
- Safety: the incidence of adverse events and serious adverse events
- timeFrame
- 3 weeks
- description
- Incidence of adverse events and serious adverse events
Secondary outcomes (4)
- measure
- Disease control rate
- timeFrame
- 6 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years and ≤80 years; 2. ECOG physical condition score: 0\~1; 3. Histologically or cytologically confirmed malignant tumor of epithelial origin in the biliary system; 4. Preoperative imaging assessment of the disease stage was III/IV; 5. The main organs function well, and the examination indicators meet the following requirements: 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: 1. Patients with other uncured malignant tumors; 2. Pregnant or lactating women who are required to withdraw from the clinical trial if they become pregnant during the study period; 3. Previous antitumor therapy for the disease in this study; 4. Participated in clinical trials of other drugs within one month; 5. Patients with a known history of other systemic serious diseases before screening; 6. Long-term unhealed wounds or incomplete healing fractures; 7. Previous organ transplantation history; 8. Abnormal coagulation function; 9. Screening for overactivity/venous thrombosis events in the previous year, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; 10. Having a history of abuse of psychotropic substances and being unable to quit or having mental disorders; 11. A history of immune deficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 12. Concomitant conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the patient's completion of the study.
References
Publications (0)
Data not yet available