biliary tract carcinoma
Conditions
Interventions
trial group:SHR1701 combined with GEMOX
Sponsors
Renji Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: In order to qualify for this trial, the subject must meet all of the following admission criteria. 1) 18-80 years old; 2) ECOG PS 0-1; 3) Pathologically or cytologically confirmed recurrent or metastatic biliary tract carcinoma that are not suitable for radical surgery (R0) treatment, non-radical surgery (R1) or palliative surgery, and have not received systemic treatment; 4) Subjects can provide sufficient fresh tumor tissue for genome sequencing and immunohistochemical testing; 5) According to the response evaluation criteria in solid tumor (RECIST 1.1), at least one measurable lesion (the longest diameter of the target lesion in spiral CT examination is >= 10mm; if there is only lymph node metastasis, the shortest diameter is >= 15mm); 6) Expected survival period >= 12 weeks; 7) Liver function AST and ALT 3 x 10^9/L, absolute granulocyte count >= 1.5 x 10^9/L; platelet >= 75 x 10^9/L; hemoglobin >= 90 g/L; creatinine clearance >= 60ml/min; total bilirubin <= 3 times the upper limit of normal (ULN); 8) Volunteer to participate in the study and sign the informed consent form. If the subject is unable to read or sign, the legal representative shall sign the informed consent form with the subjects informed consent. For subjects who are unable to express consent, then provide the above introduction and explanation to legal representative, and the legal representative will sign an informed consent form; 9) Subjects are expected to have good compliance and can cooperate with the research according to the program requirements; 10) Women of childbearing age must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and voluntarily use the appropriate method for contraception during the observation period and within 8 weeks after the last administration of the study drug; for men, surgical sterilization or consent to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug.
Exclusion criteria
Exclusion criteria: Subjects will not be allowed to enter this study if they meet any of the following conditions: 1) Have received the following treatments before this study: a. Primary/relapsed subjects have received systemic treatment in the past, except for subjects who progressed after 6 months of adjuvant chemotherapy; b. The target lesion has received radiotherapy but has not progressed; c. Participating in other therapeutic/interventional clinical trials; 2) Previously have received immunotherapy for PD-1, PD-L1, CTLA4, etc.; 3) Previously have received treatment of TGFß inhibitors; 4) Those who are Known to be allergic to the study drug or any of its excipients, or have a severe allergic reaction to other monoclonal antibodies; 5) Known uncontrolled or symptomatic active central nervous system (CNS) metastases; 6) Symptomatic subjects who have spread to the internal organs and are at risk of life-threatening complications in the short term, including subjects with uncontrollable large amounts of exudate (in thoracic cavity, pericardium, abdominal cavity); 7) Have had other active malignant tumors within 2 years before entering the study, except for skin basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, intraductal carcinoma in situ of breast, and papillary thyroid carcinoma that can be treated locally and have been cured; 8) Have any active autoimmune disease with long-term use of steroids; 9) Subjects with uncontrolled diabetes; 10) Subjects with infectious pneumonia, non-infectious pneumonia or interstitial pneumonia; 11) Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 12) Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen [HBsAg] test result is positive, HBV-DNA >= 500 IU/ml and abnormal liver function; hepatitis C is defined as hepatitis C antibody [HCV-Ab] positive, HCV-RNA higher than the detection limit of the analysis method and abnormal liver function) or combined hepatitis B and hepatitis C co-infection; 13) Within 6 months before entering the study, the following conditions occurred: myocardial infarction, severe/unstable angina pectoris, NYHA level II or higher cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; Hypertension with poor drug control (continuous increase in systolic blood pressure >= 150mmHg or diastolic blood pressure >= 100mmHg); 14) Systemic treatment of antibiotics for >= 7 days within 4 weeks before the first administration, or fever > 38.5 degrees C of unknown origin during the screening period / before the first administration (according to the investigator's judgment, fever caused by tumors can be included in the group); 15) Within 6 months before entering the study, there is a history of gastrointestinal bleeding or a trend of gastrointestinal bleeding, such as esophageal varices, local active ulcer lesions, and fecal occult blood >= (++) (fecal occult blood (+) need to perform gastroscopy); 16) Urine protein >= ++ or 24-hour urine protein > 1.0g; 17) Subjects who are unable to swallow the study drug, such as subjects with chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis), intestinal obstruction, and other various
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progress Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Overall Survival;Safety;The 4-month PFS rate;Clinical Benefit Rate; | — |
Countries
China
Contacts
Public ContactYingbin Liu
Renji Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed