Intrahepatic cholangiocarcinoma
Conditions
Interventions
Experimental group:Radiotherapy in combination with anlotinib and PD1 MAB
Sponsors
Guangxi Medical University Affiliated to Tumer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged over 18 years; 2.ECOG physical status: subjects with 0 ~ 1 score; 3.Patients are expected to survive for more than 3 months; 4.Patients with advanced intrahepatic cholangiocarcinoma diagnosed histologically or histopathologically unresectable 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: 1)Hemoglobin (HB) >= 90 g / L (no blood transfusion or blood products, no use of hematopoietic stimulating factor within 14 days); 2)The absolute value of neutrophil (ANC) >= 1.5 x 10^9 / L; 3)Platelet (PLT) >= 100 x 10^9 / L; (2)Biochemical examination: 1)Albumin (ALB) >= 30 g / L; 2)Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were < 3 x ULN; 3)Total bilirubin (TBIL) <= 1.5 x ULN; 4)Serum creatinine (CR) <= 1.5x 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 fibrolamellar cell carcinoma; 2.Patients with diffuse or multiple tumor invasion of both livers, expected normal Liver volume [liver-gtv]700mL patients who could not tolerate radiotherapy; 3.Symptomatic, untreated, or progressive central nervous system (CNS) or pneumomeningeal metastases.Asymptomatic subjects whose CNS lesions have been treated are eligible for inclusion if they meet all of the following criteria: (1)There must be lesions outside the CNS that can be measured according to RECIST V1.1; (2)The patient has no history of intracranial hemorrhage or spinal cord hemorrhage; (3)Metastases were limited to the cerebellum or supratentorial area (i.e., no midbrain, pons, medulla, or spinal cord metastases); (4)There was no evidence of progress between completion of CNS and commencement of the study; (5)No neurosurgical resection was performed within 28 days before randomization; (6)Patients have no need for continuous use of glucocorticoids for CNS disease.Stable dose anticonvulsant therapy is allowed; Asymptomatic patients who were newly diagnosed with CNS metastases at the time of screening were eligible to participate in the study after receiving radiotherapy or surgery. 4.Previous or concurrent malignant tumors, but cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc.; 5.Previous therapy experience: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that target another stimulus or synergically inhibit T cell receptors (e.g. CTLA-4, ox-40, CD137);Patients treated with thymosin alpha 1; 6.Receiving radiation therapy within 6 months prior to initial administration; 7.Prepare for or have received a solid organ or blood system transplant; 8.Active autoimmune diseases requiring systemic treatment occurred within 2 years before enrollment; 9.Diagnosis of immunodeficiency or receiving systemic glucocorticoid therapy within 7 days prior to study initial dosing (equivalent to >10mg/ day prednisone efficacy dose) or any other form of systemic immunosuppressive therapy;Except for inhaled or topical steroid doses in the absence of active autoimmune disease; 10.Severe known allergic reaction to PD-1 monoclonal antibody, its active ingredient and/or excipients (>= grade 3); 11.Any active infection requiring systemic antiinfective therapy occurred within the first 14 days of randomization. 12.Chinese medicine with anti-tumor indications had been used within 14 days before randomization; 13.Randomized to have been treated with live vaccine within the first 28 days, but inactivated viral vaccine for seasonal influenza is allowed; 14.Patients considered to be at risk for massive gastrointestinal bleeding or had the following diseases within the previous 6 months: (1)Esophagotracheal fistula, gastrointestinal perforation, abdominal fistula or intra-abdominal abscess; (2)Intestinal obstruction and/or a history of clinical signs or symptoms of gastrointestinal obstruction, including those associated with or relating to the pre-existing disease Incomplete obstruction requiring routine parenteral hydration, parenteral nutrition, or tube feeding; (3)Inflammatory processes within the abdomen, including but not limited to peptic ulcer, diverticulitis or colitis; (4)History of gastrointestinal bleeding;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Overall Survival;Time to Response;Duration of Response;Rate of Adverse Reaction;Rate of Serious Adverse Reaction; | — |
Countries
China
Contacts
Public ContactLi Jianxu
Guangxi Medical University Affiliated to Tumer Hospital
Outcome results
None listed