TACE Combined With Tislelizumab in Patients With Advanced Intrahepatic Cholangiocarcinoma
The objective of this study is to evaluate the efficacy and safety of TACE combined with Tislelizumab in patients with advanced intrahepatic cholangiocarcinoma after progression on first-line systemic therapy.
| Condition(s) | Intrahepatic Cholangiocarcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The objective of this study is to evaluate the efficacy and safety of TACE combined with Tislelizumab in patients with advanced intrahepatic cholangiocarcinoma after progression on first-line systemic therapy. |
| Who can participate | Inclusion Criteria: * Written informed consent obtained. * Age ≥ 18 years at the time of study entry. * Participants must have unresectable or metastatic histologically or cytologically confirmed intrahepatic cholangiocarcinoma * Participants must have failed 1 line of systemic regimens for advanced cholangiocarcinoma due to disease progression or toxicity. * At least one measurable site of disease as defined by RECIST1.1 criteria with spiral CT scan or MRI. * Performance status (PS) ≤ 2 (ECOG scale). * Life expectancy of at least 12 weeks. * Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/L, platelets ≥75 x103/L; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (U |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Fudan University |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2021-07-14 |
| NCT ID | NCT04954781 |
| Official listing | https://clinicaltrials.gov/study/NCT04954781 |