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Open versus controlled clinical study of Paclitaxel for injection (albumin bound) different administration regimens combined with gemcitabine in adjuvant treatment of resectable pancreatic cancer

Open versus controlled clinical study of Paclitaxel for injection (albumin bound) different administration regimens combined with gemcitabine in adjuvant treatment of resectable pancreatic cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049365
Enrollment
Unknown
Registered
2021-08-01
Start date
2021-09-01
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

Group A:Paclitaxel for injection (albumin-bound) 120mg/m^2, I.V., D1, D15, gemcitabine 1000mg/m^2, I.V., D1, D15, Q4w, 6 cycles.
Group B:Paclitaxel for injection (albumin-bound) 120mg/m^2, I.V., D1, D8, gemcitabine 1000mg/m^2, I.V., D1, D8, Q3w, 6-8 cycles.
Group C:Gemcitabine 1000mg/m^2, I.v.,.d1, D8, and sergio 60~100mg/d orally, twice a day, D1 ~14, Q3w, 6-8 cycles

Sponsors

Zhongshan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 70 years; 2.Patients with resectable pancreatic cancer confirmed by pathological examination; 3.Performance status ECOG=3 months; 5.Bone marrow function: neutrophils >=1.5x10^9/L, platelets >=100x10^9/L, hemoglobin >=90g/L; 6.Liver and kidney function: serum creatinine <=1.5 times the upper limit of normal value; AST and ALT<=2.5 times the upper limit of normal; Total bilirubin <=1.5 times normal upper limit; 7.Have good compliance with the planned treatment, understand the study process and sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1.Current or previous peripheral neuropathy of grade II or above; 2.Severe systemic infection or other serious systemic diseases; 3.Known to be allergic or intolerant to chemotherapeutic drugs or their excipients; 4.Has received anti-tumor therapy (chemotherapy, radiotherapy, immunotherapy) or any malignant tumor in the past 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer; 5.Pregnancy or lactation period, and the childbearing age of refusing to take appropriate contraceptive measures during the course of this study; 6.Participated in other research studies within 30 days before the first dose of study drug administration; Note: During screening, the investigator should ensure that the subject meets all the inclusion criteria. Subjects shall be excluded from the study if they meet the exclusion criteria due to changes (including laboratory results) in their condition after screening but before the first dose of the study drug has been administered.

Design outcomes

Primary

MeasureTime frame
2-year disease-free survival;

Secondary

MeasureTime frame
Overall survival;

Countries

China

Contacts

Public ContactFan Yue

Zhongshan Hospital Affiliated to Fudan University

fan.yue@zs-hospital.sh.cn+86 13901874150

Outcome results

None listed

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