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A Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With Gastric Cancer


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

A Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With Gastric Cancer


Inclusion Criteria:



1. Signed informed consent form

2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;

3. Histologically or cytologically confirmed gastric cancer;

4. The first-line chemotherapy failure (required containing 5-fluorouracil)

5. At least have one measurable disease(according to RECIST, Response Evaluation
Criteria in Solid Tumors )

6. Life expectancy of at least 3 months;

Exclusion Criteria:

1. Received any prior treatment including Raltitrexed;

2. Active or uncontrolled infection;

3. Concurrent treatment with an investigational agent or participation in another
therapeutic clinical trial;

4. Pregnant or lactating women.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

1 years

Safety Issue:

Yes

Authority:

China: State Food and Drug Adminstration

Study ID:

HBTH103

NCT ID:

NCT01836120

Start Date:

April 2013

Completion Date:

June 2017

Related Keywords:

  • Gastric Cancer
  • second-line chemotherapy
  • Raltitrexed
  • Stomach Neoplasms

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