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Efficacy and safety of S-1 + PD-1 mAb + anti-angiogenesis drugs for second-line treatment of liver metastases from pancreatic cancer

Efficacy and safety of S-1 + PD-1 mAb + anti-angiogenesis drugs for second-line treatment of liver metastases from pancreatic cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000030659
Enrollment
Unknown
Registered
2020-03-08
Start date
2020-03-10
Completion date
Unknown
Last updated
2020-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

Case series:S-1+PD-1 mAb+anti-angiogenesis drugs

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years old, ECOG score =3 months; 2. Patients with histologic or cytological evidence of liver metastasis of pancreatic cancer; 3. Patients with measurable lesions in the liver indicated by imaging; 4. Patients who failed first-line chemotherapy and did not use fluorouracil, PD-1 monoclonal antibody and antiangiogenic drugs; 5. Patients need to meet the following hematological indicators; (1) Neutrophil count >=1.5x10^9; (2) Hemoglobin >=10g/dL; (3) Platelet count >=100x10^9; 6. Patients need to meet the following biochemical indicators; (1) Total bilirubin =60ml/min; 7. Patients of childbearing age need to take appropriate protective measures (contraceptives or other methods of birth control) before enrollment and during the trial; 8. Patients who have signed informed consent; 9. Patients who can follow the protocol and follow-up procedure.

Exclusion criteria

Exclusion criteria: 1. Patients who have received anti-tumor treatment above the second line; 2. First line treatment for patients who have used fluorouracil, PD-1 monoclonal antibody or antiangiogenic drugs; 3. Patients with a history of other tumors, except for cervical carcinoma in situ, treated squamous cell carcinoma, bladder epithelial tumors (Ta and TIS) or other malignant tumors that have been treated radically (at least 5 years before enrollment); 4. Patients with an active bacterial or fungal infection (> = Level 2 of NCI-CTC, 3rd Edition); 5. Patients with HIV, HCV, HBV infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases that researchers consider unenrollable; 6. Patients with autoimmune diseases, immunodeficiency or treated with immunosuppressive drugs; 7. Pregnant and lactating patients. Patients of childbearing age must have a negative pregnancy test within 7 days before enrollment; 8. Patients whose informed consent or study implementation is affected by drug abuse, clinical or psychological or social factors; 9. Patients who may be allergic to PD-1 monoclonal antibody immunotherapy drugs.

Design outcomes

Primary

MeasureTime frame
Overall survival;

Secondary

MeasureTime frame
Progression-free survival;ORR;DCR;

Countries

China

Contacts

Public ContactJuan Du

Nanjing Drum Tower Hospital

dujuanglyy@163.com+86 13951826526

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026