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A phase II clinical study of SOXIRI for advanced first-line treatment of unresectable, recurrence and metastasis pancreatic cancer

A phase II clinical study of SOXIRI for advanced first-line treatment of unresectable, recurrence and metastasis pancreatic cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044005
Enrollment
Unknown
Registered
2021-03-06
Start date
2021-03-05
Completion date
Unknown
Last updated
2021-07-12

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

Conditions

pancreatic cancer

Interventions

experimental group:S-1 60mg/m2 + oxaliplatin 85mg/m2 + irinotecan 150mg/m2

Sponsors

Shandong Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The patient has good compliance, can understand the research process of this study, and sign a written informed consent; 2. ECOG = 90g/L; absolute neutrophil count (ANC) >= 1.5 x 10^9/L; platelet (PLT) >= 100 x 10^9/L; 7. Liver function standard: ALT, AST <= 2.5 x upper limit of normal (ULN), if there is liver metastasis, ALT, AST <= 5 x ULN; serum total bilirubin < 1.5 x ULN; 8. Kidney function standard: serum creatinine is within the normal range; 9. No biliary obstruction, patients who need biliary stent implantation must be completed at least 21 days before enrollment.

Exclusion criteria

Exclusion criteria: 1. Patients who have suffered from other malignant tumors in the past 5 years (except cured carcinoma in situ and skin basal cell carcinoma); 2. There is interstitial pneumonia or pulmonary fibrosis; 3. There is severe pleural effusion or ascites; 4. There are serious concomitant diseases that may affect the administration of the study, or the evaluation of the study results: such as HIV-positive, chronic HBV/HCV in an active stage, diabetes and cannot be well controlled by hypoglycemic drugs, clinically serious (I.e. active) heart disease, uncontrolled epilepsy, central nervous system disease or mental disorder history; 5. Those who have participated in other clinical research within 4 weeks before enrollment; 6. Patients considered by the investigator to be unsuitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;

Secondary

MeasureTime frame
Progression-free survival;6-month survival rate;Overall Survival;

Countries

China

Contacts

Public ContactShu Zhang

Shandong Cancer Hospital

zhangshu@csco.org.cn+86 15553126791

Outcome results

None listed

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