Biliary tract tumor
Conditions
Interventions
Experimental group:immunoradiotherapy + gemcitabine + apatinib combined with PD-L1 monoclonal antibody
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. age >= 18 years, ECOG score 0-1. 2. subjects with histologically or cytologically confirmed biliary tumours (including intrahepatic cholangiocellular carcinoma, hilar cholangiocellular carcinoma, extrahepatic cholangiocellular carcinoma and gallbladder cancer). 3. biliary tumours that are unresectable on imaging. 4. subjects need to meet the following haematological parameters: 4.1. Neutrophil count >= 1.5 x 10^9/L. 4.2. haemoglobin >= 10g/dL 4.3. platelet count >= 100 x 10^9/L 5. Subjects will be required to fulfil the following biochemical parameters: 5.1. total bilirubin = 60 ml/min 6. subjects of childbearing age are required to take appropriate protective measures (contraception or other methods of birth control) prior to enrolment and during the trial. 7. have an expected survival time of =3 months. 8. have signed an informed consent form. 9. be able to follow the study protocol 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. Received live vaccination within 28 days prior to treatment. 9. Subjects who may be allergic to PD-1 monoclonal antibody immunotherapy drugs. 10. Those considered unsuitable for inclusion by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Object response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 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