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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030602
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

Combined chemotherapy group:S-1, PD-1 mAb and anti-angiogenesis drugs

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: a. Aged 18 - 75 years, ECOG score = 3 months. b. Histological or cytologically confirmed patients with liver metastases from pancreatic cancer. c. Imaging suggests measurable lesions in the liver. d. The first-line chemotherapy failed, and the first-line chemotherapy did not use fluorouracil drugs, PD-1 mAb and anti-angiogenesis drugs. e. Patients need to meet the following hematological indicators e1. Neutrophil count >= 1.5 x 10 ^ 9 e2. Hemoglobin >= 10g / dL e3. Platelet count >= 100 x 10 ^ 9 f. Patients need to meet the following biochemical indicators f1. Total bilirubin = 60ml / min g. Patients of childbearing age need to take appropriate protective measures (contraceptives or other methods of birth control) before enrollment and during the trial. h. Informed Consent signed. i. Ability to follow research protocols and follow-up procedures.

Exclusion criteria

Exclusion criteria: a. Patients who have received anti-tumor treatment above the second line. b. First-line treatment used perfluorouracil drugs, PD-1 monoclonal antibodies or anti-angiogenic drugs. c. 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) . d. Patients with an active bacterial or fungal infection (> = Level 2 of NCI-CTC, 3rd Edition). e. Patients with HIV, HCV, HBV infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases that researchers consider unenrollable. f. Patients with autoimmune diseases, immunodeficiency or treated with immunosuppressive drugs. g. Pregnant and lactating patients. Patients of childbearing age must have a negative pregnancy test within 7 days before enrollment. h. Drug abuse, clinical or psychological or social factors that affect informed consent or research implementation. i. 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 4, 2026