Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05757336

Combination of Gemcitabine, Albumin-paclitaxel , Sintilimab and Bevacizumab in Unresectable Gallbladder Cancer

Led by Lu Wang, MD, PhD · Updated on 2023-03-07

50

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Combination of Gemcitabine, Albumin-paclitaxel , Sintilimab and Bevacizumab in Unresectable Gallbladder Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed written informed consent before any trial procedures
  • Male or female aged 18 to 75 years
  • Gallbladder carcinoma confirmed by histology or cytology
  • No prior systemic anti-tumor therapy (including chemotherapy, radiotherapy, targeted therapy, or immunotherapy)
  • Expected survival time greater than 3 months
  • At least one measurable tumor lesion according to RECIST1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Adequate organ function including: neutrophils 1.5x10^9/L, platelets 90x10^9/L, hemoglobin > 9 g/dL without recent transfusion, total bilirubin 3 times the upper limit of normal (ULN), AST and ALT 2.5x ULN (up to 5x ULN allowed with liver metastases), alkaline phosphatase 2.5x ULN, creatinine clearance 50 ml/min, good coagulation function (INR or PT 1.5x ULN), normal thyroid function (TSH 10) or stable thyroid dysfunction under treatment
  • Myocardial enzyme levels within normal range or judged non-significant by investigator
  • Female participants of childbearing age must have a negative pregnancy test within 3 days before starting treatment
  • All participants at risk of pregnancy must use effective contraception during treatment and for 120 days after last dose
Not Eligible

You will not qualify if you...

  • Other malignant diseases outside the biliary tract diagnosed within the past 5 years (except certain skin and thyroid cancers treated with curative intent)
  • Participation in other interventional clinical trials or use of investigational drugs/devices within 4 weeks before treatment
  • Active autoimmune disease requiring systemic treatment or known primary immunodeficiency
  • Active bleeding events such as hemoptysis or gastrointestinal bleeding within 3 months before treatment
  • Tumor invading large blood vessels or bleeding risk as assessed by doctors
  • Major surgery within 4 weeks before treatment (except biopsy)
  • Severe unhealed wounds, ulcers, or fractures
  • Recent use of aspirin (>325mg/day), NSAIDs, full-dose anticoagulants, or thrombolytics within 10 days before treatment
  • Hereditary bleeding or coagulation disorders or history of thrombosis
  • Systemic glucocorticoids or immunosuppressive therapy within 4 weeks before treatment (except low doses or topical use)
  • Uncontrolled pleural or abdominal effusions
  • History of organ transplantation (except corneal)
  • Allergy to study medications or their components
  • Unresolved toxicities from prior interventions above grade 1 (excluding fatigue or hair loss)
  • Known HIV infection
  • Untreated active hepatitis B or C infection
  • Recent live attenuated vaccinations within 4 weeks
  • Pregnant or breastfeeding women
  • Recent or severe esophageal or gastric varices or portal hypertension-related bleeding risk
  • Serious bleeding events within 3 months requiring intervention
  • Recent arterial or venous thromboembolic events within 6 months
  • History of gastrointestinal perforation, fistula, obstruction, or chronic bowel diseases
  • Serious uncontrolled systemic diseases including severe heart conditions, uncontrolled infections, liver disease, poorly controlled diabetes, proteinuria, or mental disorders
  • Any condition or history that may interfere with study participation or safety as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, China, 200032

Actively Recruiting

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Research Team

L

Lu Wang

CONTACT

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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