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New treatment option for Gallbladder Cancer
Official title Combination of Gemcitabine, Albumin-paclitaxel , Sintilimab and Bevacizumab in Unresectable Gallbladder Cancer
ClinicalTrials.gov ID: NCT05757336
What this study is testing
What is Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab?
Combination of Gemcitabine, Nab-paclitaxel, Sintilimab and Bevacizumab is an investigational medicine, being studied as a potential treatment for gallbladder cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 1\. Before the implementation of any trial-related procedures, sign a written informed consent 2. Male or female ≥18 years old, ≤75 years old 3...
- 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);
You likely can't join if
- Other malignant diseases outside the biliary tract diagnosed within 5 years before the first administration (excluding radically cured skin basal...
- Currently participating in treatment clinical research treatment, or receiving other research drugs or using research devices within 4 weeks before...
- Active autoimmune disease requiring systemic treatment (such as the use of disease-modifying drugs, glucocorticoids or immunosuppressants) occurred...
- 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...
- 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);
See the full eligibility criteria
- 1\. Before the implementation of any trial-related procedures, sign a written informed consent 2. Male or female ≥18 years old, ≤75 years old 3. Gallbladder carcinoma confirmed by histology or cytology 4. No previous...
- 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.
- Myocardial enzyme spectrum is within the normal range (such as simple laboratory abnormalities that are judged by the investigator to have no clinical significance are also allowed to enter the group); 9. For female...
- 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...
- Currently participating in treatment 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...
- 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;
- Current or recent (within 10 days before receiving the first dose of study drug) treatment with full-dose oral or parenteral anticoagulant or thrombolytic agent for 10 consecutive days Note: The prophylactic use of...
- Have hereditary bleeding tendency or coagulation disorder, or history of thrombosis;
- Are receiving systemic glucocorticoid therapy (excluding nasal spray, inhalation or other routes of topical glucocorticoid) or any other form of immunosuppressive therapy within 4 weeks before the first dose of the...
- There is clinically uncontrollable pleural effusion/abdominal effusion (patients who do not need drainage or stop drainage for 3 days without significant increase in effusion can be enrolled)
- Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation
- Those who are known to be allergic to active ingredients or excipients of the study drug sintilimab, bevacizumab, gemcitabine hydrochloride for injection, paclitaxel for injection (albumin-bound type)
- Has not recovered adequately from any intervention-induced toxicity and/or complications (ie, ≤ Grade 1 or reached baseline, excluding fatigue or alopecia) prior to initiating treatment
- Known history of human immunodeficiency virus (HIV) infection (ie HIV 1/2 antibody positive)
- Untreated active hepatitis B (defined as HBsAg positive and detection of HBV-DNA copy number greater than the upper limit of normal value of the laboratory laboratory of the research center) Note: Hepatitis B people who...
- If the HBV viral load before the first administration is \<2.5×103 copies/ml (500 IU/ml), the subject should receive anti-HBV treatment during the entire study treatment period
- For people whose anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load are less than the upper limit of normal value in the laboratory department of the research center, they do not need to receive preventive...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.