Clinical trial · Interventional
A Study of Tislelizumab Combined With Radiotherapy as the Second-line Treatment of Advanced Biliary Malignant Tumors
A Single-arm, Open, Exploratory Clinical Study of Tislelizumab Combined With Radiotherapy as the Second-line Treatment of Advanced Biliary Malignant Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was prematurely terminated due to difficulties in recruitment.
Summary
Brief summary (as posted)
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.
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 |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiotherapy | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- tislelizumab combined with radiotherapy
- description
- To observe and evaluate the effectiveness and safety of tislelizumab combined with radiotherapy in the treatment of patients with advanced biliary malignancies.
- interventionNames
- Combination Product: Radiotherapy
Primary outcomes (1)
- measure
- Objective response rate (ORR) assessed according to RECIST v1.1
- timeFrame
- 2 years
- description
- In this trial, the International Standard (Version 1.1) developed by the entity Tumor Equipment Assessment Standard (Recist) will be used to assess objective response rate (ORR) .
Secondary outcomes (3)
- measure
- Progression-Free Survival, PFS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathological diagnosis of Advanced biliary malignancy * The expected survival period is ≥3 months * Patients with non-extensive metastases * Except for the lesions to be radiotherapy, there is at least one measurable lesion * tumor lesions are suitable for radiotherapy * Have previously received platinum, gemcitabine or 5-FU drugs as first-line treatment, but have not used PD-1/PD-L1 monoclonal antibody treatment * In the 7 days before enrollment, the Child Pugh score of liver function is 7 or less Exclusion Criteria: * Patients with other malignant tumors * Participated in other drug clinical trials within four weeks * Clinical diagnosis of severe biliary obstruction or digestive tract obstruction in the past month * Unstable angina pectoris * Immunodeficiency * Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia * Patients who need to use corticosteroids * Serious chronic autoimmune diseases * Ulcerative enteritis, Crohn's disease and other inflammatory bowel diseases * Inflammatory and chronic diarrheal diseases such as irritable bowel syndrome; * Sarcoidosis or tuberculosis * Patients with hypersensitivity to human or murine monoclonal antibodies * Pregnant and lactating women
References
Publications (4)
- BACKGROUNDSaeed 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. PMID 30905548
- BACKGROUNDIlyas 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. PMID 28994423
- BACKGROUNDLiu 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. PMID 32984358
- BACKGROUNDSui 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. PMID 31064408