Advanced intrahepatic cholangiocarcinoma
Conditions
Interventions
trial group:Sintilimab combined with Anlotinib
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Objects over 18 years old; 2. ECoG physical status: subjects with 0 ~ 1 score; 3. Those who are expected to survive for more than 3 months; 4. Patients with intrahepatic cholangiocarcinoma which can not be resected or recurred / metastasized by histology or pathology; 5. Child Pugh liver function rating: a; 6. The patient has at least one measurable lesion (RECIST 1.1); 7. Patients without systemic chemotherapy, molecular targeted drug therapy and immunotherapy; 8. The subjects with normal main organ function shall meet the following criteria: (1) Blood routine examination: Hemoglobin (HB) >= 90 g / L (no blood transfusion or blood products, no use of hematopoietic stimulating factor) within 14 days; The absolute value of neutrophil (ANC) >= 1.5 * 10^9 / L; Platelet (PLT) >= 75 * 10^9 / L; (2) Biochemical examination: Albumin (ALB) >= 28 g / L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were < 5 * ULN; Total bilirubin (TBIL) <= 2 * ULN; Serum creatinine (CR) <= 1 * ULN; 9. Women should agree that contraceptive measures (such as intrauterine device [IUD], contraceptive or condom) must be used during the study period and within 6 months after the end of the study; the patients with negative serum or urine pregnancy test within 7 days before the study enrollment and must be non lactating patients; the men should agree to the patients who must use contraception during the study period and within 6 months after the end of the study period; 10. The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with hepatocellular carcinoma, mixed cell carcinoma or fibrotic laminar cell carcinoma diagnosed pathologically; 2. Patients with previous or concurrent malignancies (except for skin basal cell carcinoma, prostate cancer in situ and cervical carcinoma in situ); 3. Patients with previous liver transplantation history or preparing for liver transplantation; 4. Patients with multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.); 5. Patients who have been treated with VEGFR target inhibitors, including anlotinib hydrochloride capsules, or other PD-1 / PD-L1 / CTLA-4 antibody therapy or other immunotherapy for PD-1 / PD-L1 / CTLA-4; 6. Patients with arteriovenous thrombosis within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; 7. Patients with history of gastrointestinal hemorrhage or definite tendency of gastrointestinal bleeding caused by severe gastroesophageal varices; or definite tendency of gastrointestinal bleeding caused by other reasons, such as active ulcer, ulcerative colitis, etc.; occult blood in stool + + or above; and; 8. Any of the following coagulation abnormalities: prothrombin time (PT) > 16 S, activated partial thromboplastin time (APTT) > 48 s, thrombin time (TT) > 21 s, INR > 2, fibrinogen (FIB) = 150 mmHg or DBP >= 100 mmHg); (2) Patients with myocardial ischemia or myocardial infarction of grade I or above, arrhythmia (including QTc >= 480ms) and congestive heart failure (NYHA classification) with LVEF 10 mmol / L); (5) Renal failure needs hemodialysis or peritoneal dialysis; (6) Urine routine examination showed that urine protein was >= + +, and 24-hour urine protein was more than 1.0 G; (7) HIV positive; (8) HBV-DNA > 2500 IU/ml 10. Within 4 weeks before enrollment, patients with any bleeding or bleeding events >= CTC AE 3 had unhealed wounds, ulcers or fractures; 11. Patients with a history of psychotropic substance abuse and unable to quit or with mental disorders; 12. Patients with any active autoimmune disease or history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; subjects who need bronchodilator for medical intervention cannot be included); but the following patients are allowed to be included: vitiligo, psoriasis, alopecia, control group without systemic treatment Patients with type I diabetes were treated with replacement therapy for hypothyroidism with normal thyroid function; 13. According to the researchers' judgment, there were other patients who were not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Disease Control Rate;Overall Survival;Time to Response;Duration of Response;Surgical Resection Rate;Rate of Adverse Reaction;Continuous Medication Time; | — |
Countries
China
Contacts
Public ContactYang Xinrong
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed