Combination of Gemcitabine, Albumin-paclitaxel , Sintilimab and Bevacizumab in Unresectable Gallb… (NCT05757336) | Clinical Trial Compass
RecruitingPhase 2
Combination of Gemcitabine, Albumin-paclitaxel , Sintilimab and Bevacizumab in Unresectable Gallbladder Cancer
China50 participantsStarted 2022-12-22
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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);
✓. Alkaline phosphatase (AKP) ≤2.5×ULN
✓. Creatinine clearance rate (calculated using the Cockcroft-Gault formula) ≥ 50 ml/min;
✓. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN;
✓. Normal thyroid function, defined as thyroid-stimulating hormone (TSH ≤ 10) within the normal range; thyroid dysfunction without clinical significance after thyroid hormone supplementation can also be included.
Exclusion criteria
What they're measuring
1
objective response rate
Timeframe: 9 weeks
2
Safety：the incidence of adverse events and serious adverse events
. 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;
✕. Imaging shows tumor invasion/infiltration of large blood vessels or bleeding tendency assessed by researchers or radiologists;
✕. Received major surgical treatment within 4 weeks before the first study drug administration (except for surgery for biopsy);
✕. Severe unhealed wound ulcers or fractures;
✕. Current or recent (within 10 days before receiving the first dose of the study drug) use of aspirin (\>325mg/day) or other non-steroidal anti-inflammatory drugs known to inhibit platelet function for 10 consecutive days;