Actively Recruiting
Evaluate Sintilimab Plus Bevacizumab Combined With Gemcitabine and Albumin-paclitaxel in First-line Treatment of Initially Unresectable Gallbladder Cancer Phase II Study
Led by Lu Wang, MD, PhD · Updated on 2023-03-07
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment using Gemcitabine, Nab-paclitaxel, Sintilimab, and Bevacizumab for patients with initially unresectable gallbladder cancer. This phase II, single-center study aims to assess the objective response rate, safety, disease control rate, disease-free survival, overall survival, and the possibility of successful surgical removal of primary tumors. The study uses Simon's two-stage design with an initial 15 patients, expanding to 45 if sufficient response is seen. The treatment involves cycles every three weeks, with two dose regimens of Gemcitabine and Nab-paclitaxel, combined with fixed doses of Sintilimab and Bevacizumab. Patients receive these drugs intravenously and continue treatment until their cancer becomes operable, disease progresses, intolerable side effects occur, or they choose to stop. Evaluations occur every nine weeks to decide on surgery or continuation. Participants will have regular safety assessments of side effects using CTCAE 5.0 criteria and monitoring visits every 90 days after treatment ends until death, loss to follow-up, or study completion. Researchers will track tumor response, disease progression, survival outcomes, and the rate of successful surgeries. The total participation duration varies depending on individual treatment response and follow-up status.
CONDITIONS
Brief Title
Combination of Gemcitabine, Albumin-paclitaxel , Sintilimab and Bevacizumab in Unresectable Gallbladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- Gallbladder carcinoma confirmed by histology or cytology
- No prior systemic anti-tumor treatments
- Expected survival time greater than 3 months
- At least one measurable lesion per RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Adequate organ function as defined by specific blood counts and lab values
- Negative pregnancy test for women of childbearing potential before first treatment
- Use of effective contraception during treatment and for 120 days after last drug administration
You will not qualify if you...
- Other malignant diseases diagnosed within 5 years except certain skin and thyroid cancers
- Participation in other clinical trials or use of research drugs within 4 weeks before treatment
- Active autoimmune diseases requiring systemic treatment
- Active bleeding or tumor invasion of major blood vessels
- Recent major surgery or unhealed wounds
- Use of high-dose aspirin, NSAIDs, or anticoagulants recently
- Hereditary bleeding disorders or history of thrombosis
- Recent systemic glucocorticoid or immunosuppressive therapy
- Uncontrolled pleural or abdominal effusion
- Known organ transplantation except cornea
- Allergy to study drugs
- Unrecovered toxicity from previous interventions
- HIV infection
- Untreated active hepatitis B or C
- Pregnant or lactating women
- Recent esophageal or gastric variceal bleeding
- Life-threatening bleeding events or thromboembolic events within 6 months
- History of gastrointestinal perforation or severe bowel disease
- Serious uncontrolled systemic diseases including severe heart conditions, infections, liver disease, poorly controlled diabetes, significant proteinuria, or mental disorders
- Any other conditions that may interfere with study participation or results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Treatment cycles every 3 weeks until disease progression or discontinuation
Participants receive a combination of Gemcitabine, Nab-paclitaxel, Sintilimab, and Bevacizumab as first-line treatment for unresectable gallbladder cancer.
Visits every 3 weeks for drug administration
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
Research Team
L
Lu Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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