A Study of Tislelizumab Combined With Radiotherapy as the Second-line Treatment of Advanced Biliary Malignant Tumors

Summary

Biliary tract cancer (BTC) accounts for 4% of the malignant tumors of the digestive system, and the incidence has increased significantly in recent years. For advanced malignant tumors of the biliary tract, the existing treatment methods are very limited and the effective rate is low. At present, gemcitabine combined with platinum therapy is the first-line standard treatment for advanced biliary tract cancer. In recent years, tumor immunotherapy has made huge breakthroughs. There are also research attempts in advanced biliary tract cancer. A study published in the international top medical journal NEJM in 2015 showed that PD-1 monoclonal antibody treatment has mismatch gene repair defects. Patients with advanced biliary tract tumors have a higher curative effect. It suggests that PD-1 monoclonal antibody is worthy of in-depth study in the treatment of biliary tract tumors. In the previous clinical studies of PD-1 in the treatment of biliary tract tumors conducted by our center, it was observed that the tumor control of some patients was stable with the combination of immunotherapy and radiotherapy. In view of the observations in the clinical research of our unit, relevant case reports, and the mechanism of the combination of radiotherapy and immunotherapy, we speculate that in patients with biliary tract cancer, radiotherapy and immunotherapy have a certain combined sensitization effect. Therefore, it is planned to carry out clinical research on the second-line treatment of advanced biliary tract cancer with radiotherapy and immunotherapy. This study will explore the effectiveness and safety of tislelizumab combined with radiotherapy in the treatment of patients with advanced biliary malignant tumors (BTC) in second-line and above, with a view to improving the therapeutic effect of biliary tract tumors.

Timeline

Start

2020-10-01

Primary completion

2021-12-01

Completion

2022-10-01

Outcome

Outcome not reported

Stopped (Enrollment): “The study was prematurely terminated due to difficulties in recruitment.”

Publications

• Background Saeed A, Park R, Al-Jumayli M, Al-Rajabi R, Sun W. Biologics, Immunotherapy, and Future Directions in the Treatment of Advanced Cholangiocarcinoma. Clin Colorectal Cancer. 2019 Jun;18(2):81-90. doi: 10.1016/j.clcc.2019.02.005. Epub 2019 Feb 27.
• Background Ilyas SI, Khan SA, Hallemeier CL, Kelley RK, Gores GJ. Cholangiocarcinoma - evolving concepts and therapeutic strategies. Nat Rev Clin Oncol. 2018 Feb;15(2):95-111. doi: 10.1038/nrclinonc.2017.157. Epub 2017 Oct 10.
• Background Liu ZL, Liu X, Peng H, Peng ZW, Long JT, Tang D, Peng S, Bao Y, Kuang M. Anti-PD-1 Immunotherapy and Radiotherapy for Stage IV Intrahepatic Cholangiocarcinoma: A Case Report. Front Med (Lausanne). 2020 Aug 28;7:368. doi: 10.3389/fmed.2020.00368. eCollection 2020.
• Background Sui M, Li Y, Wang H, Luo Y, Wan T, Wang X, Hu B, Cheng Y, Lv X, Xin X, Xu Q, Wang G, Lu S. Two cases of intrahepatic cholangiocellular carcinoma with high insertion-deletion ratios that achieved a complete response following chemotherapy combined with PD-1 blockade. J Immunother Cancer. 2019 May 7;7(1):125. doi: 10.1186/s40425-019-0596-y.

Drugs

Indications