biliary tract cancer
Conditions
Sponsors
Xiangyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Be at least 18 years; 2.Advanced gallbladder carcinoma and bile duct carcinoma confirmed by histopathology or cytology; 3.Received at least one systemic treatment; Those who have received one regimen of adjuvant or neoadjuvant chemotherapy and progressed within 6 months are considered to have received one systemic treatment; Approved Chinese patent medicines with anti-tumor indications whose last administration was completed at least 2 weeks ago can be included; 4.Child-pugh GRADE A (5-6 points) or better GRADE B ( = 12 weeks; 7.At least one measurable lesion (RECIST 1.1 criteria); 8.The functions of major organs and bone marrow are basically normal: (1)Blood routine: White blood cell >= 3.5 x 10^9/L, neutrophil >= 1.5 x 10^9/L, platelet >= 75 x 10^9/L, hemoglobin >= 90 g/L; (2)International standardized ratio (INR) = 50% as measured by two-dimensional echocardiography; 9.Fully understand this study, voluntarily participate in it, and sign informed consent. Fertile male or female patients voluntarily used effective contraceptive methods, such as double screen contraception, condoms, oral or injectable contraceptives, and intrauterine devices, during the study period and within 6 months of the last study use. All female patients will be considered fertile unless the woman has gone through natural menopause, artificial menopause or sterilization (e.g., hysterectomy, bilateral adnexectomy or radioactive ovarian irradiation).
Exclusion criteria
Exclusion criteria: 1.Received approved or ongoing systematic anti-tumor therapy within 2 weeks prior to enrollment, including photodynamic therapy, chemotherapy, radical radiotherapy, ablation, local radiotherapy (palliative radiotherapy for bone metastasis was allowed to be completed at least 2 weeks prior to study drug therapy), biological immunotherapy, targeted therapy, etc.; 2.The investigator determined that liver metastases accounted for 50% or more of the total liver volume; 3.Clinically intervened biliary obstruction was not in remission or required anti-infective therapy 14 days before the first study drug treatment; 4.Previous liver transplantation; 5.Have untreated central nervous system metastases, patients who have received previous systemic and radical treatment for brain or meningeal metastasis (radiotherapy or surgery), have been stable for at least 1 month as confirmed by imaging, and have stopped systemic sex hormone therapy ( > 10 mg/day of prednisone or other equivalent therapeutic hormones) for more than 2 weeks, and have no clinical evidence are eligible for inclusion; 6.Participated in clinical trials of other unapproved or unmarketed drugs in China and received corresponding experimental drugs within 4 weeks prior to enrollment; 7.Received any surgical or invasive treatment or operation (except intravenous catheterization, puncture and drainage, etc.) within 4 weeks before enrollment; 8.The investigator identified clinically significant electrolyte abnormalities; 9.The patient currently has hypertension that cannot be controlled by drugs, defined as: systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 90 mmHg; 10.The patient has any current disease or condition that affects drug absorption, or the patient cannot take solventinib orally; 11.The patient currently has gastrointestinal diseases such as active gastric and duodenal ulcers and ulcerative colitis, or active bleeding of unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by researchers; 12.Patients with obvious evidence or history of bleeding tendency within 3 months before enrollment (bleeding > 30 mL within 3 months, hematemesis, black feces, hematozoia), hemoptysis (fresh blood > 5 mL within 4 weeks) or thromboembolism events (including stroke events and/or transient ischemic attack) within 12 months; 13.Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass surgery within 6 months prior to enrollment; Congestive heart failure (NYHA) grade > 2; Ventricular arrhythmias requiring medication; ECG showed QTc interval >= 480 ms; 14.Has had other malignant tumors in the past 5 years, other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix after radical surgery; 15.Active or uncontrolled severe infection ( >= CTCAE grade 2 infection); 16.Known human immunodeficiency virus (HIV) infection; A known history of clinically significant liver disease, including viral hepatitis [a known hepatitis B virus (HBV) carrier must exclude active HBV infection, i.e., positive HBV DNA (> 1 x 10^4 copies/mL or > 2000 IU/mL); Known hepatitis C virus infection (HCV) and POSITIVE for HCV RNA ( > 1 x 10^3 copies/mL), or other hepatitis, cirrhosis]; 17.Unmitigated toxicity above CTCAE level 1 due to any prior anticancer therapy, excluding alopecia, lymphocytopenia, and neu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Objective response rate;Overall survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactGong Wei
Xiangyang Central Hospital
Outcome results
None listed