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Efficacy and safety of SOX chemotherapy combined with anti-pd1 immunotherapy and hypofractionated immunosensitization radiotherapy in the second line treatment of advanced pancreatic cancer

Efficacy and safety of SOX chemotherapy combined with anti-pd1 immunotherapy and hypofractionated immunosensitization radiotherapy in the second line treatment of advanced pancreatic cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049799
Enrollment
Unknown
Registered
2021-08-09
Start date
2021-08-15
Completion date
Unknown
Last updated
2022-04-19

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:SOX chemotherapy combined with anti-pd1 immunotherapy and hypofractionated immunosensitization radiotherapy

Sponsors

The Affiliated Drum Tower Hospital to Medical School of Nanjing University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years old, ECOG score = 3 months; 2. Patients with advanced pancreatic cancer confirmed by histopathology or cytology; 3. Imaging indicates that there are distant measurable lesions; 4. After the first-line chemotherapy fails and progresses, and the first-line chemotherapy does not use fluorouracil, platinum drugs and anti-PD-1 monoclonal antibody; 5. Patients should meet the following hematological indicators: neutrophil count >=1.5x10^9/L; hemoglobin >=10g/dL; platelet count >=100x10^9/L; 6. Patients should meet the following biochemical indicators: total bilirubin = 60ml/min; 7. Patients of childbearing age need to take appropriate protective measures (contraceptive measures or other birth control methods) before enrollment and during the trial; 8. Has signed the informed consent; 9. Able to follow the study protocol and follow-up procedures.

Exclusion criteria

Exclusion criteria: 1. Have received more than second-line anti-tumor therapy; 2. The patient has a history of other tumors, unless it is cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumor (Ta and TIS) or other malignant tumors that have received radical treatment (at least 5 years before enrollment) ; 3. The patient has an active bacterial or fungal infection (>= Grade 2 of NCI-CTC, 3rd edition); 4. The patient has HIV, HCV, HBV infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases deemed unenrollable by the investigator; 5. Patients with autoimmune diseases or immunodeficiencies who are treated with immunosuppressive drugs; 6. Pregnant and lactating women. Women of childbearing age must have a negative pregnancy test within 7 days of enrollment; 7. Substance abuse, clinical or psychological or social factors that compromise informed consent or study conduct. May be allergic to PD-1 monoclonal antibody immunotherapy drugs.

Design outcomes

Primary

MeasureTime frame
Medium Progress-free survival;

Secondary

MeasureTime frame
Medium Overall survival;Objective reponse rate;Diseas control rate;Changes in serum CEA/CA199/CA125;Safety;

Countries

China

Contacts

Public ContactDu Juan

The Affiliated Drum Tower Hospital to Medical School of Nanjing University

dujuanglyy@163.com+86 25 83106666-61341

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026