Biliary tract tumor
Conditions
Interventions
Experimental group:Tegafur + gemcitabine + anti-PD-1 monoclonal antibody combined with synchronous radiotherapy
Sponsors
Nanjng Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years, ECOG score 0-1. 2. Subjects with histologically or cytologically confirmed biliary tumors (including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma). 3. Imaging findings indicated unresectable biliary tumors (including locally advanced and distant metastases; conversion therapy was used in this study; the main enrolled population was locally advanced, that is, the tumor did not metastasize far away, the tumor was relatively localized, but had infiltrated surrounding tissues, or had lymph node metastasis). 4. Subjects shall meet the following hematological criteria: (1) Neutrophil count >=1.5x10^9/L; (2) Hemoglobin >=10g/dL; (3) Platelet count >=100x10^9/L. 5. Subject shall meet the following biochemical indicators: (1) Total bilirubin =60ml/min. 6. Subjects of childbearing age are required to use appropriate protective measures (contraception or other birth control methods) before enrollment and during the study. 7. Informed consent has been signed. 8. Ability to follow research protocols and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Have received systemic antitumor therapy. 2. Subjects had a history of other neoplasms, unless cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial neoplasms (Ta and TIS), or other neoplasms that had received radical treatment (at least 5 years prior to enrollment). 3. Subjects had an active bacterial or fungal infection (>= Grade 2 of NCI-CTC, 3rd edition). 4. Subjects had HIV, HCV, HBV infection, uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease, or other conditions considered inadmissible by the investigators. 5. The subjects have autoimmune diseases or immune defects and are treated with immunosuppressive drugs. 6. Pregnant and lactating subjects. Women of childbearing age must have a negative pregnancy test within 7 days of enrolling. 7. Substance abuse, clinical or psychological or social factors that may affect informed consent or conduct of the study. 8. Subjects who may be allergic to PD-1 monoclonal antibody immunotherapy drugs. 9. Those considered unsuitable for inclusion by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Object response rate;R0 resection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median progression-free survival;Median overall survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactLiu Baorui /Shen Jie
Gulou Hospital Affiliated to School of Medicine of Nanjing University
Outcome results
None listed