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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01836120

Enrollment

100

Registered

2013-04-19

Start date

2013-04-30

Completion date

2017-06-30

Last updated

2013-04-19

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

Conditions

Gastric Cancer

Keywords

second-line chemotherapy, Raltitrexed

Brief summary

A study of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with Gastric Cancer.The purpose of this study is to compare the activity of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with gastric carcinoma by estimating progression free survival (PFS) in each treatment arm.

Interventions

DRUGRaltitrexed plus Docetaxel

Raltitrexed plus Docetaxel (Raltitrexed 3mg/m2 d 1; Docetaxel 75mg/m2 d1, every 3 weeks, 4-6 cycles)

DRUGDocetaxel

Docetaxel (Docetaxel 75mg/m2 d1, every 3weeks,4-6 cycles)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS)	1 years

Secondary

Measure	Time frame
Objective Response Rate (ORR)	1 year
Overall Survival (OS)	1 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026