Phase II Study of Nimotuzumab and Concurrent Radiotherapy and Capecitabine for Inoperable Locally Advanced or Recurrent Gastric Cancer
18 Years
75 Years
Both
Gastric Cancer, Concurrent Chemoradiotherapy
Trial Information
Phase II Study of Nimotuzumab and Concurrent Radiotherapy and Capecitabine for Inoperable Locally Advanced or Recurrent Gastric Cancer
There is no standard treatment for patients with inoperable locally advanced or
residual/relapsed gastric cancer. For the former ones, 5-fluorouracil(5-FU) based concurrent
chemoradiotherapy is a recommended treatment regimen. Concurrent capecitabine
chemoradiotherapy showed similar results. So far, more and more studies have shown that
drugs targeting at EGFRs play an important role in antitumor treatment. Nimotuzumab, an
anti-EGFR monoclonal antibody, has shown its safety and efficiency in many phase I/II
studies. Because of poor survival of patients with inoperable locally advanced or
residual/relapsed gastric cancer, the efficiency of nimotuzumab plus concurrent capecitabine
chemoradiotherapy need to be further analyzed.
Inclusion Criteria:
- 18-75 years old, male or female
- Gastric cancer with measurable lesions, and the diameter is at least 1 cm
- Karnofsky score: at least 70
- Estimated survival: at least 6 months
- No prior target therapy or radiotherapy
- No severe hypertension, cardiac disease, or diabetes mellitus
- Normal blood routine and chemical tests
- Signed consent
Exclusion Criteria:
- Other malignancies simultaneously except in situ cervix or non-melanoma skin cancer
- Extensive distant metastases
- Pregnancy or in lactation
- Allergic to 5-Fluorouracil
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
progression-free survival
Outcome Description:
progression-free survival: the time between tumor regression to progression
Outcome Time Frame:
1 year progression-free survival
Safety Issue:
Yes
Principal Investigator
jing jin, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Chinese Acedemy of Medical Sciences
Authority:
China: Food and Drug Administration
Study ID:
CH-GI-010
NCT ID:
NCT01180166
Start Date:
May 2010
Completion Date:
September 2013
Related Keywords:
- Gastric Cancer
- Concurrent Chemoradiotherapy
- Gastric cancer
- concurrent chemoradiotherapy
- target therapy
- Stomach Neoplasms
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