Combining chemotherapy and targeted therapy for advanced biliary tract cancer

Effects and Safety of GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma：a Prospective, Single-arm, Multi-center Phase II Study

This study is testing a new combination of chemotherapy and targeted therapy to see if it can help people with advanced biliary tract cancer live longer and feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: Tislelizumab, chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05668884 on ClinicalTrials.gov

What this trial studies

This phase 2 study evaluates the effects and safety of a combined therapy using oxaliplatin and gemcitabine chemotherapy alongside Donafenib and Tislelizumab for patients with advanced biliary tract carcinoma. The study targets patients with stages III and IV of the disease, which typically have poor survival rates and limited treatment options. The combination aims to improve efficacy and safety based on prior phase I trial results that indicated promising outcomes. The study will expand on these findings by increasing the sample size to better assess the treatment's effectiveness.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed advanced biliary tract carcinoma and specific health criteria.

Not a fit: Patients with earlier stages of biliary tract carcinoma or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with advanced biliary tract carcinoma.

How similar studies have performed: Previous studies have shown promising results with similar combinations of therapies in treating advanced biliary tract carcinoma, but this specific combination is being further explored.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years and ≤75 years;
* ECOG physical condition score: 0\~1;
* Histologically or cytologically confirmed advanced biliary tract carcinoma (including gallbladder, intrahepatic and extrahepatic cholangiocarcinoma);
* Preoperative imaging assessment of the disease stage was III/IV;
* At least one measurable lesion (according to mRECIST criteria)
* Child-Pugh classification : A or B
* 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);
* thyroid function:Thyroid function is normal, thyroid stimulating hormone TSH is defined to be within the normal range. If baseline TSH is outside the normal range, T3 and T4 can be included if they are within the normal range;
* Myocardial enzyme profile:The myocardial enzyme profile was in the normal range (if simple laboratory abnormalities that were not clinically significant as determined by the investigators could also be included);
* Estimated survival time ≥ 3 months;
* Sign the informed consent voluntarily;
* Good compliance, and family members willing to cooperate with follow-up.

Exclusion Criteria:

* Patients with other uncured malignant tumors;
* Pregnant or lactating women who are required to withdraw from the clinical trial if they become pregnant during the study period;
* Previous antitumor therapy for the disease in this study;
* Participated in clinical trials of other drugs within one month;
* Patients with a known history of other systemic serious diseases before screening;
* Obstructive jaundice (after active treatment such as biliary drainage or stent, the patients can be included in the group after the liver function returns to normal);
* Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number greater than the upper limit of normal in the clinical laboratory of the study center);
* Active HCV infected persons (HCV antibody positive with HCV RNA levels above the lower limit of detection);
* Allergic to any investigational drug or excipient;
* Long-term unhealed wounds or incomplete healing fractures;
* Previous organ transplantation history;
* Having a history of abuse of psychotropic substances and being unable to quit or having mental disorders;
* A history of immune deficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
* Concomitant conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the patient's completion of the study.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Lu Wang, M.D.

Conditions Biliary Tract Carcinoma; Donafenib; Tislelizumab; Effects; Safety