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

NCT04866836 | Terminated Phase 2

• 1 other identifier: Hepatobiliary Center
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) assessed according to RECIST v1.1

  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) .

  2 years

Secondary Outcomes (3)

• Progression-Free Survival, PFS

  2 years

• 6-month OS

  6 months

• Tumor size

  2 years

Study Arms (1)

tislelizumab combined with radiotherapy

EXPERIMENTAL

To observe and evaluate the effectiveness and safety of tislelizumab combined with radiotherapy in the treatment of patients with advanced biliary malignancies.

Combination Product: Radiotherapy

Interventions

Radiotherapy COMBINATION_PRODUCT

Patients who meet the criteria for enrollment first receive radiotherapy, either IMRT or SBRT, and the relative biological effect dose is\> 40Gy. On the 7th day (±3 days) after radiotherapy, start to give tislelizumab 200 mg, IVD, q3w, and continue the treatment until disease progression, unacceptable toxic radiotherapy, death or meet the description in the protocol Any discontinuation criteria shall be subject to whichever occurs firs

Also known as: PD-1 monoclonal antibody

tislelizumab combined with radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

Related Publications (4)

• 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.

  PMID: 30905548 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.

  PMID: 28994423 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.

  PMID: 32984358 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.

  PMID: 31064408 BACKGROUND

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Radiotherapy; spartalizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Changxian Li, PhD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To observe and evaluate the effectiveness and safety of tislelizumab combined with radiotherapy in the treatment of patients with advanced biliary malignancies.

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 30, 2021
• Study Start: October 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: October 1, 2022
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)