biliary tract cancers
Conditions
Interventions
Intervention Group:Surufatinib plus GEMOX
Sponsors
the first affiliated hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18-75 years old; 2.Unresectable or metastatic gallbladder cancer and cholangiocarcinoma diagnosed by histopathology or cytology; 3.Have not received systemic treatment for unresectable or metastatic biliary tract cancer; have received a regimen of adjuvant or neoadjuvant chemotherapy and relapsed 6 months after the end of chemotherapy can be included in the group; have been approved with anti-tumor The last administration of proprietary Chinese medicines for indications is completed at least 2 weeks before randomization and can be included in the group; 4.Liver function Child-Pugh Grade A (5-6 points) or better grade B (= 12 weeks; 7.There is at least one measurable lesion (RECIST 1.1 standard, see Appendix 2); 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 (see Appendix 6); (5) The heart function is normal, and the left ventricular ejection fraction (LVEF) detected by two-dimensional echocardiography is >= 50%; 9.Fully understand this research, participate voluntarily, and sign an informed consent form; 10.Male or female patients with fertility voluntarily use effective contraceptive methods, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. during the study period and within 6 months of the last study medication. All female patients will be considered fertile, unless the female patient has been naturally menopausal, has undergone artificial menopause or sterilization (such as hysterectomy, bilateral adnexectomy or radiation ovarian irradiation, etc.).
Exclusion criteria
Exclusion criteria: 1.Anti-tumor therapy received within 4 weeks prior to the initiation of the investigational treatment, including, but not limited to, chemotherapy, radical radiotherapy, targeted therapy, immunotherapy, anti-tumor Chinese medicine treatment, hepatic chemoembolization, cryoablation, and radiofrequency ablation; 2.More than 50% liver metastasis; 3.Patient with other serious diseases or clinical conditions, including but not limited to uncontrolled active infection, etc; 4.Previous received liver transplantation; 5.Have untreated central nervous system metastasis; 6.Participation in other drug clinical trials within the last 4 weeks; 7.Received any surgery or invasive treatment or operation (except venous catheterization, puncture drainage, etc.) within 4 weeks before the start of the enrollment; 8.Have clinically significant serum potassium, calcium (albumin-bound ionic or corrected), or magnesium level that exceeds the normal range; 9.Have uncontrolled hypertension, defined as systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg, while under anti-hypertension treatment; 10.The patient currently has any disease or condition that affects the absorption of the drug, or the patient cannot take Surufatinib orally; 11.Have a gastrointestinal disease or condition that investigators the suspect may affect drug absorption, including, but not limited to, active gastric and duodenal ulcers, ulcerative colitis, and other digestive diseases, gastrointestinal tumor with active bleeding, or other gastrointestinal conditions that may cause bleeding or perforation, according to the investigator's judgment; 12.History or presence of a serious hemorrhage (> 30 ml within 3 months), hemoptysis (>5 ml blood within 4 weeks), or a thromboembolic event (including transient ischemic attack) within 12 months; 13.Have electrocardiogram (ECG) corrected QT interval (QTc) >= 480 msec; 14.Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection; 15.Active or uncontrolled serious infection (>= CTC AE grade 2 infection); 16.History of clinically significant hepatic disease, including, but not limited to, known hepatitis B virus (HBV) infection with HBV DNA positive (copies >= 1 x 10^4/ml); known hepatitis C virus infection with HCV RNA positive (copies >= 1 x 10^3/m); or liver cirrhosis, etc. 17. Have toxicity from a previous anti-tumor treatment that has not returned to grade 0 or grade 1 (except for hair loss); 18.Symptomatic peripheral neuropathy (CTCAE >= grade 2); 19.Women who are pregnant or lactating; 20.For any other diseases, clinically significant metabolic abnormalities, abnormal physical examinations or abnormal laboratory examinations, according to the judgment of the investigator, there is reason to suspect that the patient has a certain disease or condition that is not suitable for the use of the study drug (such as having epileptic seizures). And need treatment), or will affect the interpretation of research results, or put the patient in a high-risk situation. 21.Urine protein >= ++ or 24-h urine protein > 1.0 g as indicated by urinalysis; 22.Have received anti-VEGF/VEGFR-targeted drugs and progressed upon these drugs; 23.Received drugs containing St John's Wort, within 3 weeks prior to the first study treatment, or received other strong inducers with CYP3A4 or strong inhibitors with CYP3A4, within two weeks prior to the first study treatment; 24.Have a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS in 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;DoR;PFS;TTP;OS; | — |
Countries
China
Contacts
Public ContactYin Xiao-Yu
the first affiliated hospital of Sun Yat-sen University
Outcome results
None listed