Advanced Biliary Tract Cancer
Conditions
Interventions
Experimental group:Decitabine combined with GEMOX and sintilimab
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Pathologically confirmed biliary tract cancers; 2.Age >=18 years, male or female; 3.With a life expectancy of >=3 months; 4.ECOG performance status of 0-1; 5.Have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). 6.Never received prior systemic treatment for biliary tract tumors; 7.Normal function of major organs; 8.Patients voluntarily enrolled in the study by signing an informed consent form;
Exclusion criteria
Exclusion criteria: 1.Patients with previous or concurrent other malignant tumors, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix. Other tumors, such as small gastric stromal tumors or other early-stage tumors that have undergone radical treatment and are judged by the investigator to not impact the patient’s life in the short term, may be excluded; 2.Participation in other drug clinical trials within the past four weeks; 3.Patients known to have central nervous system (CNS) metastases or a history of CNS metastases prior to screening. Patients with clinically suspected CNS metastasis must undergo a CT or MRI within 28 days prior to enrollment to rule out CNS metastasis; 4.History of unstable angina, new-onset angina within three months prior to screening, myocardial infarction within six months prior to screening, or arrhythmias (including QTcF >=450 ms for males and >=470 ms for females) requiring long-term anti-arrhythmic medication, and NYHA Class II or higher heart failure; 5.Urinalysis showing proteinuria =++, confirmed by a 24-hour urine protein quantification >1.0 g; 6.Female subjects: Must be surgically sterilized, postmenopausal, or agree to use medically approved contraception during the study and for six months after study treatment. A negative serum or urine pregnancy test within seven days prior to enrollment is required, and subjects must not be breastfeeding. Male subjects: Must be surgically sterilized or agree to use medically approved contraception during the study and for six months after study treatment; 7.History of immunodeficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 8.Patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia, or those requiring corticosteroid treatment; 9.History of chronic autoimmune diseases, such as systemic lupus erythematosus, ulcerative colitis, Crohn’s disease, irritable bowel syndrome, or chronic diarrhea-related conditions; history of sarcoidosis or tuberculosis; active hepatitis B, hepatitis C, or HIV infection; 10.Patients with hypersensitivity to human or murine monoclonal antibodies; 11.History of substance abuse or addiction to psychiatric drugs that cannot be discontinued, or psychiatric disorders; 12.Patients with clinically symptomatic pleural effusion or ascites requiring intervention; 13.Any concurrent severe condition that, in the investigator’s judgment, poses a risk to patient safety or may affect the patient’s ability to complete the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DCR;QoL;PG-SGA; | — |
Countries
China
Contacts
Public ContactKai Chen
The First Affiliated Hospital of Soochow University
Outcome results
None listed