Biliary pancreatic malignancy
Conditions
Interventions
Cholangiocarcinoma group:?dT cells+ gemcitabine+ tegafur
Malignant tumors of the pancreas group:?dT cells+ gemcitabine+ Albumin bound paclitaxel
Sponsors
General Hospital of the Northern Theater Command of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70; 2. Histopathological or clinical diagnosis of inoperable or metastatic biliary pancreatic malignancy; 3. CT or MRI confirmed the existence of at least one measurable target lesion in accordance with RECIST 1.1 standards; 4. ECOG physical condition =2, estimated survival =12 weeks; 5. No hepatitis B or C; HIV, CMV; No autoimmune defects; 6. No immunosuppressive therapy within 2 weeks; 7. No major organ dysfunction, neutrophil absolute value =1.5×109/L; Platelet count =80×109/L; Total bilirubin =1.5× normal upper limit; AST=5 x upper limit of normal; ALT=5× normal upper limit; The lowest hemoglobin level was 10g/L; 8. Patients with BMS must be stable for at least three months after treatment; 9. Agree to the study protocol and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Other anti-tumor therapies should be performed simultaneously; 2. Symptomatic brain and/or pia metastases; 3. Previous or co-existing malignant neoplasms, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ; 4. No measurable lesions according to RECIST 1.1 standards; 5. ECOG PS > 2; Estimated survival time is less than 12 weeks; 6. Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (RNA PCR-positive) or active hepatitis B virus (DNA PCR-positive) 7. Receiving immunosuppressive therapy; 8. Severe heart disease, severe hypertension; Active bleeding or uncured thromboembolic disease; 9. Drug dependents; Subjects with uncontrolled mental illness; Cognitive dysfunction; 10. During pregnancy or lactation, participate in other clinical researchers within 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;PFS;DCR;Imaging indicators;Laboratory inspection indicators;QOL-C30; | — |
Countries
China
Contacts
Public ContactZheng Zhendong
General Hospital of the Northern Theater Command of the Chinese People's Liberation Army
Outcome results
None listed