The Efficacy of Chemotherapy Combined With Immunocheckpoint Inhibitors in Advanced Biliary Malignancies

Trial Title: The Efficacy of Chemotherapy Combined With Immunocheckpoint Inhibitors in Advanced Biliary Malignancies

NCT ID: NCT05487443

Condition: Gemcitabine
Biliary Tract Cancer
Immune Checkpoint Inhibitors

Conditions: Official terms:
Biliary Tract Neoplasms
Gemcitabine

Study type: Interventional

Study phase: Phase 2/Phase 3

Overall status: Unknown status

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Gemcitabine-based chemotherapy regimen combined with immunocheckpoint inhibitors
Description: Gemcitabine-based chemotherapy regimen combined with immunocheckpoint inhibitors for first-line treatment of advanced biliary malignancies
Arm group label: Chemotherapy combined with immunotherapy

Summary: To the patient of terminal biliary malignancy tumor, how should the patient's treatment plan choose ? To address this problem, this study intends to analyze systemic venous gemcitabine-based chemotherapy regimen combined with immune checkpoint inhibitors in patients with advanced BTC, to evaluate the long-term efficacy and toxicity of patients, and to search for predictable biomarkers. In order to clarify the advantages and disadvantages of intravenous chemotherapy combined with immunotherapy for patients with advanced biliary malignancy, provide certain basis for clinical work, and then select the most suitable treatment plan for patients according to the different characteristics of individual patients.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Non-bedridden male or female, aged ≥18 years and ≤80 years. Adopts the surgery of Chinese medical association branch of biliary surgery group released the diagnosis and treatment of the bile duct carcinoma surgery expert consensus on biliary tract tumor diagnosis standard, refer to biliary lining after epithelial malignant tumors, including intrahepatic bile duct carcinoma, liver bile duct carcinoma, distal bile duct carcinoma and portal vein gallbladder, or postoperative pathology biopsy for biliary tumor, Staging was performed according to the Joint Council on Cancer (AJCC) TNM version 8. - the ECOG score of 0 to 2 points. - the histologic diagnosis of unresectable locally advanced, recurrent and/or metastatic malignant tumor, biliary pathology for adenocarcinoma, untreated or always neoadjuvant therapy/adjuvant therapy over time to relapse time > 6 months. - not intentional, liver, brain, kidney and other important organ dysfunction and bleeding tendency; No history of blood diseases; Cardiac insufficiency, chest pain (medically uncontrollable). No myocardial infarction occurred during the 12 months prior to the study. - the subjects baseline blood routine and biochemical indexes in accordance with the following standards: 80 g/L or higher hemoglobin; Neutrophil absolute count (ANC) ≥1.5×109/L; Platelet ≥100×109/L; ALT, AST≤2.5 times the normal upper limit; ALP≤2.5 times normal upper limit value; Serum total bilirubin <1.5 times normal upper limit; Serum creatinine <1 times normal upper limit; Serum albumin ≥30g/L. - there are measurable evaluation target lesions according to the RECIST criteria. Exclusion Criteria: - Younger than 18 or more than 76 years old (inclusive); Or poor general condition, ECOG score > 2. - participated in other clinical trials. - a blood coagulation dysfunction or history or severe clinical haematology (activities) heart disease, such as symptomatic coronary heart disease (CHD), New York heart association (NYHA) class II or more severe congestive heart failure or severe arrhythmia, drug intervention or within the past 12 months has a history of myocardial infarction. - patients with past history has obvious liver and kidney function is not complete. - Pregnancy and lactation women, women of childbearing age in the baseline period pregnancy test positive pregnancy test subjects or not. Menopausal women must be in menopause for at least 12 months before pregnancy is considered impossible. - multi-source patients with carcinoma and repetition, or brain or meningeal metastasis. All landowners have uncontrolled seizures, central nervous system disease or a history of mental disorders, t

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Hangzhou First People's Hospital

Address:
City: Hangzhou
Country: China

Contact:
Last name: Song Zheng

Phone: 13656648239
Email: tztree@126.com

Start date: August 1, 2022

Completion date: August 30, 2024

Lead sponsor:
Agency: First People's Hospital of Hangzhou
Agency class: Other

Source: First People's Hospital of Hangzhou

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05487443