GP Chemotherapy in Combination With Tislelizumab and Ociperlimab as First-line Treatment in Advanced BTC
Megadott ok: Repeat registration
Key facts
- Where
- Shanghai, KínaSee the site
- Phase
- 2. fázis
Where in Kína
- Zhongshan Hospital,Fudan UniversityShanghai, KínaNo longer taking part
Trial details
- Who runs it
- Fudan University
- Trial code
- NCT05019677
- Record updated
- 2022. április 4.
- Original description
This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of GP (Gemcitabine/Cisplatin) in combination with Tislelizumab and Ociperlimab as first-line treatment in participants with unresectable advanced Biliary Tract Carcinoma (BTC).Read full original descriptionShow less
A Study to Evaluate GP Chemotherapy in Combination With Tislelizumab(Anti-PD-1) and Ociperlimab(Anti-TIGIT) as First-line Treatment in Participants With Unresectable Advanced BTC
This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of GP (Gemcitabine/Cisplatin) in combination with Tislelizumab and Ociperlimab as first-line treatment in participants with unresectable advanced Biliary Tract Carcinoma (BTC).
Inclusion: • Subjects with a histopathological or cytologically diagnosis of BTC; The participants must be required to sign an informed consent; At least one measurable lesion (RECIST 1.1); No previous systematic treatment for BTC; Child-Pugh Score, Class A; ECOG performance status 0 or 1; Adequate organ function; Life expectancy of at least 3 months.
Exclusion: • Diagnosis of mixed ampullary, hepatocellular and cholangiocarcinoma; Known history of serious allergy to any monoclonal antibody; Known central nervous system metastases and/or leptomeningeal disease prior to treatment; Portal hypertension with esophageal or gastric varices within 6 months prior to initiation of treatment; Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment; Any active malignancy prior to the start of treatment; Active or history of autoimmune disease; Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation; Pregnant or lactating women.