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

Brief Title

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

Official Title

An Open, Single-arm Prospective Clinical Study Evaluating the Efficacy of Systemic Venous Gemcitabine-based Chemotherapy Combined With Immunocheckpoint Inhibitors in First-line Treatment of Advanced Biliary Malignancies

Brief 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.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional

Primary Outcome

Progression free survival (PFS)

Secondary Outcome

 Overall survival (OS)

Condition

Gemcitabine

Intervention

Gemcitabine-based chemotherapy regimen combined with immunocheckpoint inhibitors

Study Arms / Comparison Groups

 Chemotherapy combined with immunotherapy

Description:  Gemcitabine-based chemotherapy regimen combined with immunocheckpoint inhibitors for first-line treatment of advanced biliary malignancies

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

50

Start Date

August 1, 2022

Completion Date

August 30, 2024

Primary Completion Date

September 30, 2023

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

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

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Location Countries

China

Location Countries

China

NCT ID

NCT05487443

Organization ID

20211216

Responsible Party

Sponsor

Study Sponsor

First People's Hospital of Hangzhou

Study Sponsor

, , 

Verification Date

December 2021