Combination of Gemcitabine, Albumin-paclitaxel , Sintilimab and Bevacizumab in Unresectable Gallbladder Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLu Wang, MD, PhD
About this trial
Study design: Prospective, single-arm, single-center phase II clinical study; Primary endpoint: Objective response rate via investigator, Safety; Secondary endpoints: disease control rate, disease-free survival, overall survival, and proportion of acceptable radical resection of primary lesions; Main characteristics of enrolled patients: Patients with initially unresectable gallbladder cancer; Interventions: Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab; Sample size: Using Simon's two-stage design, 15 patients in the first stage, and if more than 4pts response, enlarge the sample size to 45 patients in total; Treatment until: 1. successfully conversed to resectable disease 2. progressed disease 3. intolerable toxicity 4. patient requests withdrawal; Research process: In this study, patients who met the inclusion criteria were evaluated at the end of every 9 weeks of treatment, up to surgical treatment or disease progression; Safety evaluation: Evaluate adverse reactions according to CTCAE 5.0; Follow up: every 90 days (±7 days) until the subject died, lost follow-up or the end of the study.
Eligibility criteria
Qualifiers
Absolute value of neutrophils (ANC) ≥ 1.5x109/L and platelets ≥ 90×109/L without using granulocyte colony-stimulating factor in the past 14 days;
Hemoglobin > 9g/dL without blood transfusion or use of erythropoietin in the past 21 days;
Total bilirubin ≤ 3 × upper limit of normal (ULN);
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are ≤2.5×ULN (patients with liver metastases are allowed ALT or AST ≤5×ULN);
Disqualifiers
Other malignant diseases outside the biliary tract diagnosed within 5 years before the first administration (excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma, and/or radically resected carcinoma in situ, radically cured thyroid papillary carcinoma can also be included after surgery);
Currently participating in interventional clinical research treatment, or receiving other research drugs or using research devices within 4 weeks before the first administration;
Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) occurred before the first dose. Replacement therapies (eg, thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy. Known history of primary immunodeficiency. Only patients with autoimmune antibody positive need to confirm whether there is an autoimmune disease according to the investigator's judgment;
Active hemoptysis (spitting up at least 2.5ml or 1/2 teaspoon of fresh blood) within 3 months before the first study drug administration, and active gastrointestinal bleeding within 3 months before administration;
Trial design
Treatments tested in this trial
- Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Lu Wang, MD, PhD
Lead sponsor
Fudan University
Sponsor institution
Source ClinicalTrials.gov