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Clinical research of S-1 alone and S-1 plus gemcitabine for patients with advanced pancreatic cancer

Clinical research of S-1 alone and S-1 plus gemcitabine for patients with advanced pancreatic cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIN-17011333
Enrollment
Unknown
Registered
2017-05-08
Start date
2017-06-01
Completion date
Unknown
Last updated
2017-05-22

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

Conditions

pancreatic cancer

Interventions

S-1 Alone:S-1
S-1 combined with gemcitabine:S-1 combined with gemcitabine

Sponsors

The Affiliated Hospital of Inner Mongolia Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. After the puncture, pancreatic lymph node biopsy or ascites cytology confirmed pancreatic cancer, or imaging and laboratory examination and clinical symptoms were diagnosed with pancreatic cancer, and can not give up or surgical treatment, according to the American Cancer Association (AJCC) 8th TNM pancreatic cancer staging, clinical stage III and IV patients; 2. Patients with pancreatic cancer confirmed by operation and pathology, and the recurrence and metastasis after radical operation could not be resected; 3. All the patients were proved to have at least one objectively measurable or evaluable tumor; 4. The 18 years of age or older, gender, pathological type, physical condition before chemotherapy (Karnofsky Performance Status, KPS) is more than 60 points, is expected to receive more than 2 cycles of chemotherapy, the expected survival time of 3 months; 5. Blood routine, liver function, renal function, cardiac function and pulmonary function were normal; 6. The chemotherapy within 3 weeks without progesterone, adrenal cortical hormone and metabolic hormone therapy; 7. We have not received prior radiotherapy and chemotherapy; 8. The chemotherapy of retreatment were previously unused gemcitabine and 5-fluorouracil treatment, from the last chemotherapy interval of at least 4 weeks; 9. In addition to not outside of the pancreas and other parts of primary malignant tumor; 10. The signed informed consent and willing to cooperate with the treatment, long-term follow-up.

Exclusion criteria

Exclusion criteria: Patients with rapid progression of disease after two cycles of chemotherapy; Patients with severe toxic reaction during chemotherapy, can not tolerate the continued chemotherapy; 1. Patients in pregnancy or lactation; 2. Combined with other primary tumors, poor compliance; 3. Diabetes or infection is not effectively controlled, or other serious non tumor factors of the disease to 4. prevent further chemotherapy, are interrupted treatment; 5. The requirements for various reasons quittters.

Design outcomes

Primary

MeasureTime frame
the clinical efficacy;Clinical Benefit Response;adverse effect;

Secondary

MeasureTime frame
overall survival;

Countries

China

Contacts

Public ContactChen Chunhua

The Affiliated Hospital of Inner Mongolia Medical University

chunhuachen@163.com+86 13347120068

Outcome results

None listed

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