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The Efficacy and Safety of Gemcitabine/Nab-Paclitaxel/S-1 Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Cancer

The Efficacy and Safety of Gemcitabine/Nab-Paclitaxel/S-1 Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068818
Enrollment
Unknown
Registered
2023-03-01
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

Pancreatic cancer

Interventions

GAS group:GAS

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. pathologically confirmed locally advanced or advanced pancreatic cancer patient, unresectable, diagnosis with comprehensive judgment based on pathology and imaging (CT or MRI); 2. no previous antitumor treatment (including chemotherapy, radiotherapy, surgery or other investigational therapy); 3. Aged 18 to 75 years old, both gender; 4. Karnofsky Performance Status (KPS) of >70 or ECOG PS score 0- 1; 5. At least one measurable tumor lesion: long diameter of leision >=10 mm and short diameter of lymph node >=15 mm by spiral CT; the largest diameter must be >=20 mm by normal CT or physical examination; 6. The results of liver and kidney function tests and blood tests within 1 week before enrollment must meet the following conditions: Neutrophils (ANC) >=1.5x10^9/L, Platelets (PLT) >=80x10^9/L, Hemoglobin (HGB) >=80g/L, Serum creatinine (Cr) =3 months; 8. Female patients should not be pregnant during the trial; serum and urine pregnancy tests of lactating female patients should be negative during screening, and not breast-feeding; both male and female patients are required to take reliable contraception during the trial; 9. Patients voluntarily participate the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Known severe hypersensitivity to any ingredient of the study drugs; 2. Patients with evidence of central nervous system (CNS) metastasis; 3. History of other malignancies within 5 years (Except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix); 4. Serious pleural effusion or ascites; 5. Serious uncontrolled medical illness, acute infection, recent history of myocardial infarction (within 3 months); 6. severe mental disorders; 7. might be pregnant, pregnant or lactating women; 8. unsuitable for enrollment in the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
Objective remission rate, ORR;

Secondary

MeasureTime frame
Overall survival, OS;progression-free survival, PFS;safety;

Countries

China

Contacts

Public ContactCao Dan

West China Hospital, Sichuan University

caodan316@163.com+86 189 8060 5963

Outcome results

None listed

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