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Phase 2
18 Years
Open (Enrolling)
Advanced Well-differentiated Pancreatic Neuroendocrine Tumor

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Trial Information

Inclusion Criteria:

1. 18 years of age and older

2. ECOG ≤2

3. Pathologically confirmed locally advanced or metastatic well-differentiated
pancreatic neuroendocrine tumor(G1,G2)

4. Prior treatment with one-line chemotherapy is allowed, with the exception of prior
treatment with temozolomide or dacarbazine or endostatin within the past 6 months

5. Disease progressed during or after last therapy

6. Minimum of 4 weeks since any major surgery, completion of radiation, or completion of
all prior systemic anticancer therapy

7. Disease progressed within the past 12 months。

8. Patients must have at least one measurable site of disease according to RECIST1.1
criteria that has not been previously irradiated.

9. Adequate bone marrow, liver and renal function

10. Life expectancy 3 months or more

11. Patient informed consent。

Exclusion Criteria:

1. Concurrent use of Octreotide or other drug that may have efficacy in neuroendocrine

2. 2 or more lines of prior chemotherapy。

3. Patients who have any severe and/or uncontrolled medical conditions or other
conditions that could affect their participation in the study

4. Uncontrolled infectious disease。

5. Other malignancies within the past 5 years except for adequately treated carcinoma of
the cervix or basal or squamous cell carcinoma of the skin

6. Uncontrolled brain or leptomeningeal metastases

7. Patients with known hypersensitivity to temozolomide or endostatin。

8. Patient could not take tablets。

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival

Outcome Time Frame:

From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Safety Issue:



Department of Science and Research, Peking Union Medical College Hospital, Beijing, China:

Study ID:




Start Date:

April 2013

Completion Date:

Related Keywords:

  • Advanced Well-differentiated Pancreatic Neuroendocrine Tumor
  • temozolomide
  • endostatin
  • advanced
  • well-differentiated
  • pancreatic neuroendocrine tumor
  • Neuroendocrine Tumors
  • Adenoma, Islet Cell