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A prospective, multicenter, single-arm clinical study of NASOX in combination with camrelizumab for neoadjuvant/conversion therapy of pancreatic cancer

A prospective, multicenter, single-arm clinical study of NASOX in combination with camrelizumab for neoadjuvant/conversion therapy of pancreatic cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113349
Enrollment
Unknown
Registered
2025-11-27
Start date
2025-11-27
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Pathologically or histologically confirmed resectable and accompanied by high-risk factors (high-risk factors include: serum CA19-9, CA19-9>1000 U/ml

Interventions

experimental group:Irinotecan hydrochloride liposome + oxaliplatin +S-1+Camrelizumab

Sponsors

The first people's Hospital of Yunnan Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The patient fully understood this study, voluntarily participated and signed the informed Consent Form (ICF); 2. Age >= 18 years old; 3. Pathologically or histologically confirmed resectable and accompanied by high-risk factors (high-risk factors include: serum CA19-9, CA19-9>1000 U/ml;) Larger primary pancreatic tumors, with the maximum diameter of the primary tumor >3.0cm; The maximum diameter of regional lymph nodes is greater than 1.0 cm. NRS score: 7 to 10 points; Researchers judged patients with pancreatic cancer who had significant weight loss, were on the verge of being resectable, and were in the locally advanced stage. 4. Has not received any form of anti-tumor treatment in the past; 5. According to RECIST1.1/mRECIST standards, the patient has at least one measurable target lesion; 6. Eastern Cancer Collaboration Group (ECOG) Physical Condition Score: 0-2 points; 7. Expected survival time >= 3 months; 8. Absolute neutrophil count (ANC) >= 1.5×10^9/L, platelet count >= 100×10^9/L and hemoglobin >= 90 g/L (no blood transfusion, blood products, use of granulocyte colony-stimulating factor or other hematopoietic stimulating factors for correction within 14 days prior to the laboratory test); 9. Liver and kidney functions: Serum creatinine <= 1.5 times the upper limit of the normal value; AST and ALT <= 2.5 times the upper limit of the normal value (<= 5 times the upper limit of the normal value for patients with liver invasion); Total bilirubin <= 1.5 times the upper limit of the normal value (<= 3 times the upper limit of the normal value for patients with liver invasion);

Exclusion criteria

Exclusion criteria: 1. Any form of anti-tumor treatment, including radiotherapy, chemotherapy, molecular targeted therapy and immunotherapy, has been received within 4 weeks before enrollment; 2. Have hypersensitivity reactions to any research drug or its components; 3. Concurrent severe uncontrolled concurrent infections or other severe uncontrolled concomitant diseases, moderate or severe kidney injury; (Such as advanced infection, uncontrollable hypertension, diabetes, etc.); 4. Heart diseases evaluated by the cardiology department as intolerant to treatment; 5. Active hepatitis B and C infections (positive hepatitis B surface antigen and hepatitis B virus DNA exceeding 1x103 copies /mL; Hepatitis C virus RNA exceeds 1x103 copies /mL; 6. Human Immunodeficiency virus (HIV) infection (HIV antibody positive); 7. Have had or are currently concurrently suffering from other malignant tumors (except for effectively controlled non-melanoma basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix, and other malignant tumors that have been effectively controlled without treatment in the past five years); 8. Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures; 9. Those with other malignant tumors that require treatment; 10. The researchers determined that patients were not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Surgical resection rate;R0 resection rate;

Countries

China

Contacts

Public ContactJin Yun

The first people's Hospital of Yunnan Province

colourcloud@126.com+86 871 63633241

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026