Advanced Gallbladder Cancer
Conditions
Interventions
Treatment group:Epalrestat and Tovorafenib: 5 mg/kg, administered on a 21-day cycle. AG regimen: (Paclitaxel (albumin-bound) and Gemcitabine are infused on Days 1 and 8
one cycle lasts 3 weeks). Gemcitabine is administered at a dose of 1000 mg/m^2, and paclitaxel (albumin-bound) is administered at a dose of 125 mg/m^2. A total of six cycles are planned
specific dosages and treatment schedules will be adjusted according to the patient’s individual condition.
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiaotong University of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Signed informed consent. 2.Age 18-75 years. 3.ECOG performance status 0-2, Child-Pugh class A. 4.Histologically or cytologically confirmed advanced gallbladder cancer, deemed unresectable for R0 resection. 5.Adequate organ function: (1)ANC >=1.5×10^9/L, platelets>=75×10^9/L, hemoglobin>=90 g/L. (2)Serum creatinine =60 mL/min. (3)Total bilirubin =3 months. 7.Non-pregnant, non-lactating women and willingness to use contraception during and for 3 months after treatment.
Exclusion criteria
Exclusion criteria: 1.Severe systemic infection or uncontrolled comorbidities (e.g., heart failure, thyroid disease, psychiatric disorders); active autoimmune disease requiring medication. 2.Known allergy or intolerance to chemotherapy agents. 3.Prior antitumor therapy (chemotherapy, radiotherapy, immunotherapy) within the past year, or history of other malignancies (except cured cervical carcinoma in situ or non-melanoma skin cancer). 4.Pregnancy, lactation, or unwillingness to use contraception. 5.Participation in another clinical trial within 30 days before the first dose. 6.Unwillingness to participate or inability to provide informed consent. 7.Any other condition that, in the investigator's judgment, may affect patient safety or compliance. Note: During screening, investigators must ensure that subjects meet all inclusion criteria. If a subject's condition (including laboratory test results) changes after screening but before administration of the first study drug, such that they now meet an exclusion criterion, the subject should be excluded from the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical Conversion Rate;The Objective Response Rate;Adverse Events (AEs), Serious Adverse Events (SAEs), and Surgery-Related Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 Resection Rate;Downstaging Rate ;Pathologic Response Rate;Disease Control Rate (DCR) ;Recurrence-Free Survival (RFS);Overall Survival (OS) ;Exploratory biomarker; | — |
Countries
China
Contacts
Public ContactGong Wei
Xinhua Hospital Affiliated to Shanghai Jiaotong University of Medicine
Outcome results
None listed