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A Phase II Study to Evaluate the Safety and Efficacy of Sintilimab Combined with Nab-paclitaxel and Gemcitabine for Neoadjuvant and Adjuvant Therapy of Patients with Resectable and Borderline Resectable Pancreatic Cancer

A Phase II Study to Evaluate the Safety and Efficacy of Sintilimab Combined with Nab-paclitaxel and Gemcitabine for Neoadjuvant and Adjuvant Therapy of Patients with Resectable and Borderline Resectable Pancreatic Cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064424
Enrollment
Unknown
Registered
2022-10-07
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Resectable and Borderline Resectable Pancreatic Cancer

Interventions

experimental group:Sintilimab Combined with Nab-paclitaxel and Gemcitabine

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate and sign informed consent; 2. Aged 18-75 years, no gender limit; 3. ECOG body status score =3.0 x 10^9/L; Absolute count of neutrophils (ANC) >=1.5 x 10^9/L; Platelet (PLT) >=100 x 10^9/L; Hemoglobin (Hgb) >=90 g/L; 8. Blood biochemical indexes: AST (SGOT), ALT (SGPT) <=2.5 x upper limit of normal value (ULN); Total bilirubin (TBIL) <=ULN; Serum creatinine (CRE) <=1.5 x ULN; 9. Coagulation function: prothrombin time (PT), International standardized ratio (INR) <=1.5 x ULN; 10. Ability to comply with research visit plans and other program requirements. Remarks: ECOG score, body status score of the Eastern Oncology Consortium.

Exclusion criteria

Exclusion criteria: 1. Imaging evaluation can resectable tumor diameter <=2 cm; 2. Accompanied by malignancies of other systems; 3. Use of any other non-antitumor investigational drug within 4 weeks prior to neoadjuvant therapy; 4. Pregnancy, autoimmune disease, severe hyperthyroidism/hypothyroidism, central nervous system disease, mental illness, unstable angina, congestive heart failure, severe arrhythmia and other uncontrollable serious diseases; 5. Have a history of allergy to study drugs or drugs of similar structure; 6. Patients who are taking warfarin anticoagulant and require long-term use; 7. Patients expected to be out of observation for 14 days or more during the treatment period.

Design outcomes

Primary

MeasureTime frame
2-year overall survival;progression-free survival;—

Secondary

MeasureTime frame
overall survival;events-free survival;objective response rate;disease control rate;recurrence-free survival;surgical resection rate;R0 resection;major pathological response;node-negative resection;the occurrence rate and severity of perioperative complications;—

Countries

China

Contacts

Public ContactLiu Liang

Zhongshan Hospital, Fudan University

liuliang.zlhospital@fudan.edu.en+86 21 31587861

Outcome results

None listed

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