Cholangiocarcinoma
Conditions
Interventions
experimental group:Patients with metastatic biliary tract cancer (including gallbladder cancer and cholangiocarcinoma) who have undergone first-line treatment
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Metastatic gallbladder cancer and cholangiocarcinoma diagnosed by histopathology or cytology; 3. Systemic treatment for unresectable or metastatic biliary tract cancer with a regimen; after receiving a regimen of adjuvant or neoadjuvant chemotherapy and recurrence less than 6 months after chemotherapy, they can be included in the group; have been approved the last administration of the proprietary Chinese medicine with anti-tumor indications was completed 2 weeks before the medication and can be included in the group; 4. Child-Pugh grade A (5-6 points) or better grade B (= 12 weeks; 7. There is at least one measurable focus (RECIST 1.1 standard); 8. The main organs and bone marrow function are basically normal: (1) Blood routine: white blood cells >= 4.0 x 10^9/L, neutrophils >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, hemoglobin >= 90g/L; (2) International normalized ratio (INR) 60mL/min; (5) The cardiac function is normal, and the left ventricular ejection fraction (LVEF) >= 50% detected by two-dimensional echocardiography. 9. Fully understand this study, volunteer to participate, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Received local anti-tumor therapy within 4 weeks before the first study drug treatment, including but not limited to photodynamic therapy, ablation, and local radiotherapy (allowed to complete palliative radiotherapy for bone metastases at least 2 weeks before study drug treatment); 2. The researcher determines that liver metastases account for 50% or more of the total liver volume; 3. Within 4 weeks before the first study drug treatment, there is ascites that needs to be drained or treated with diuretics (CTCAE>=2), or there is pleural effusion or pericardial effusion that needs to be drained and/or accompanied by shortness of breath; 4. The biliary obstruction after clinical intervention has not been relieved or needs anti-infective treatment 14 days before the first study drug treatment; 5. Have received liver transplantation in the past; 6. Active brain metastasis or spinal cord compression; for patients with brain metastases who have previously received treatment, if the clinical condition is stable and imaging evidence does not show disease progression within 4 weeks before the first study drug treatment, and before the first administration there is no need to receive corticosteroid treatment within 4 weeks and can be considered for inclusion; 7. Suffered from other malignant tumors in the past 5 years (except for skin basal cell or squamous cell carcinoma after radical operation, or carcinoma in situ such as cervix and breast); 8. Major surgical operations (except biopsy) have been performed within 4 weeks before the first study drug treatment, or the surgical incision has not healed completely; 9. Symptomatic peripheral neuropathy (CTCAE >= 2); 10. Active, known or suspected autoimmune diseases; but patients with vitiligo who do not require systemic treatment within 2 years before the first study drug treatment are allowed to be included in the group; hypothyroidism requiring only thyroid hormone replacement therapy and only insulin replacement Treated type I diabetes, as well as pituitary inflammation, adrenal insufficiency, patients who only require physiological hormone replacement therapy can be included; 11. There is a history of HIV, or active bacterial or fungal infection that requires systemic treatment within 14 days before the first study drug treatment; 12. Previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis, and symptomatic interstitial lung disease or active pneumonia found on chest CT scan within 4 weeks before the first study drug treatment; 13. During the screening period, HBV DNA >= 2000 IU/ml (or >= 104 copies/ml), entecavir must be reduced to 2000 IU/ml (or 104 copies/ml) before being included in the group; for selected HBsAg (+) it is recommended to receive antiviral therapy at the same time during the trial period, and the original drug or entecavir can be used; for subjects who are positive for HCV RNA, the investigator will decide whether to receive antiviral therapy at the same time; 14. Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina, cerebrovascular accident or transient ischemic attack, congestive within 6 months before enrollment Heart failure (New York Heart Association grade >= 2); arrhythmias that require other antiarrhythmic drugs except for beta blockers or digoxin; QTcF interval of 450 milliseconds (ms) for repeated ECG detecti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Objective response rate;Disease control rate;Duration of disease remission;Time to disease progression; | — |
Countries
China
Contacts
Public ContactYanru Qin
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed