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Clinical Trials List

Protocol NumberGO42661
NCT Number(ClinicalTrials.gov Identfier)NCT04677504

2021-03-01 - 2023-04-15

Phase II

Terminated3

ICD-10C24.9

Malignant neoplasm of biliary tract, unspecified

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9156.9

Malignant neoplasm of biliary tract, part unspecified

A Phase II, Randomized, Double-Blind Placebo-Controlled Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer

  • Trial Applicant

  • Sponsor

    Hoffmann-La Roche

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Ming-Huang Chen Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Chih-Hung Hsu Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Jen-Shi Chen Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Biliary Tract Cancer

Objectives

This study will evaluate the efficacy and safety of atezolizumab with bevacizumab in combination with cisplatin and gemcitabine(CisGem), compared with atezolizumab in combination with CisGem, in participants with advanced biliary tract cancer (BTC) who have not received prior systemic therapy. Treatment will consist of a chemotherapy combination phase followed by a cancer immunotherapy (CIT)/placebo phase.

Test Drug

Atezolizumab(TecentriqR)
Bevacizumab(AvastinR)

Active Ingredient

Atezolizumab
Bevacizumab

Dosage Form

IVT
IVT

Dosage

1200mg/20ml
400mg/16ml

Endpoints

Primary Outcome Measures :

Progression Free Survival (PFS) [ Time Frame: Randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)(up to approximatly 3-5 years) ]
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)

Inclution Criteria

Inclusion Criteria:

Considered to be eligible to receive platinum-based chemotherapy, in the investigator's judgment
Documentation of recurrent/metastatic or locally advanced unresectable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) scans
Histologically or cytologically confirmed diagnosis of iCCA, eCCA, or GBC
No prior systemic therapy for advanced BTC
At least one measurable untreated lesion (per RECIST v1.1)
Adequate biliary drainage with no evidence of ongoing infection
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Life expectancy of > 3 months
Adequate hematologic and end-organ function
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Exclusion Criteria

Exclusion Criteria:

Recurrent disease <=6 months after curative surgery or <= 6 months after the completion of adjuvant therapy
Prior local regional therapy such as radioembolization
Combined or mixed hepatocellular/cholangiocarcinoma
Clinically significant hepatic encephalopathy within the 12 months prior to Day 1 of Cycle 1
National Cancer Institute Common Terminoogy Criteria for Adverse Events Grade >= 2 peripheral neuropathy
Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to Day 1 of Cycle 1
Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of atezolizumab or within 6 months after the final dose of bevacizumab, cisplatin or gemcitabine
Active or history of autoimmune disease or immune deficiency
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
History of malignancy other than BTC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
Symptomatic, untreated, or actively progressing CNS metastases
For patients with lung metastases, if one of the following criteria applies: Large, centrally located pulmonary metastases; Clear tumor infiltration into the thoracic great vessels seen on imaging; Clear cavitation of pulmonary lesions seen on imaging
Active tuberculosis
Co-infection with HBV and HCV
Treatment with systemic immunostimulatory agents or immunosuppressive medication
Inadequately controlled arterial hypertension
History of hypertensive crisis or hypertensive encephalopathy
Significant vascular disease
Evidence of bleeding diathesis or significant coagulopathy
Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)
Preexisting renal impairment, myelosuppression, or hearing impairment

The Estimated Number of Participants

  • Taiwan

    24 participants

  • Global

    150 participants

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