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A Randomized , Open-label, Multicenter, Phase II Study to Compare the Efficacy of S1 and S1 Plus LV as Second Line Treatment on Gemcitabine-refractory Patients With Inoperable or Advanced Pancreatic Cancers

Phase 2
18 Years
75 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

A Randomized , Open-label, Multicenter, Phase II Study to Compare the Efficacy of S1 and S1 Plus LV as Second Line Treatment on Gemcitabine-refractory Patients With Inoperable or Advanced Pancreatic Cancers

Inclusion Criteria:

1. Histologically confirmed inoperable or APC.

2. Failure of one prior gemcitabine-based regimen was required,chemotherapy used as a
radiation sensitizer in the adjuvant or locally advanced setting was not considered
as a prior regimen. Patients received last adjuvant gemcitabine-based chemotherapy
less than (or equal to) six months can be enrolled into this study.

3. Disease had to be measurable by the Response Evaluation Criteria in Solid Tumors
(RECIST) criteria.

4. Age ≥18 years old.

5. ECOG performance status 0 or 1.

6. Written informed consent and able to comply with the protocol.

Exclusion Criteria:

1. Local (Stage IA to IIB) pancreatic cancer and locally advanced (stage III) pancreatic
cancer. Patients relapsing with metastatic disease, after initial diagnoses with
local disease can be enrolled into this study.

2. Previous adjuvant radiotherapy for pancreatic cancer, except for patients with
progressive lesions outside the radiation port who completed the radiotherapy at
least 6 months prior to study entry.

3. More than (or equal to) six months since last adjuvant chemotherapy. Adjuvant therapy
without gemcitabine based adjuvant therapy is not allowed. Patient must have
recovered from all treatment related toxicity prior to enrollment and must have
documented evidence of disease progression (metastatic) following prior chemotherapy.

4. No previous gemcitabine-based therapy for inoperable or APC.

5. Other primary tumour (including primary brain tumours) within the last 5 years prior
to enrollment, except for adequately treated carcinoma in situ of the cervix or basal
cell skin cancer.

6. Evidence of spinal cord compression or current evidence of CNS metastases.

7. History or evidence upon neurological exam of CNS disease (unless adequately treated
with standard medical therapy) e.g. uncontrolled seizures.

8. Inability to take oral medication, prior surgical procedures affecting absorption or
resulting in the requirement for IV alimentation or parenteral nutrition with lipids,
and/or active peptic ulcer disease

9. Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days
prior to study treatment start, or within 14 days with a confirmatory urine pregnancy
test within 7 days prior to study treatment start

10. Men and women of childbearing potential (<2 years after last menstruation) not using
effective means of contraception (oral contraceptives, intrauterine contraceptive
device, barrier method of contraception in conjunction with spermicidal jelly or
surgically sterile)

11. Current or recent (within the 30 days prior to starting study treatment) treatment
with another investigational drug or participation in another investigational study

12. Evidence of any other disease, metabolic dysfunction, physical examination finding,
or clinical laboratory finding giving reasonable suspicion of a disease or condition
that contraindicates use of an investigational drug, or patient at high risk from
treatment complications

13. Known hypersensitivity to any of the study drugs

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival (OS)

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Xu jianming, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences


China: Ethics Committee

Study ID:




Start Date:

February 2010

Completion Date:

July 2014

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic cancer
  • S1
  • S1 plus LV
  • second-line therapy
  • Pancreatic Neoplasms