Capecitabine plus paclitaxel with sequential capecitabine alone as the firstline therapy in the treatment of recurrent and late gastric cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-TNC-07000014

Enrollment

Unknown

Registered

2007-06-28

Start date

2006-06-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Advanced gastric cancer

Interventions

Single group, no control:Capecitabine plus paclitaxel with sequential capecitabine alone

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age: 18-75 years; 2. Karnofsky score >70; 3. Participant must sign the known agreement; 4. gastric cancer is confirmed by pathologic diagnosis; 5. more than one measurable focus according to following standard: (1) spiral CT, MRI: maximum diameter >10mm; (2) X line: maximum diameter >20mm; (3) subcutaneous focus and lymphnode: maximum diameter >20mm (Bone metastasic focus, ascites and pleural effusion are not considered as measurable focal). 6. without chemical therapy history or progression 6 months after systemic and regular (new) assist chemical therapy, such as progression happens one year after application of capecitabine or paclitaxel; 7. without radiation therapy history or more than 4 weeks after radiation therapy (only applied outside the estimated sites); 8. Participant's baseline blood routine and biochemical index according to following standard: hemoglobin >9g/dl, leukocyte >4,000/mm3, 100,000/mm3, AL, AST <2.5 folds of normal upper limit; <5 folds of normal upper limit (with liver metastasic focus), ALP <2.5 folds of normal upper limit; <5 folds of normal upper limit (with bone or liver metastasic focus) total serum bilirubin <1.5 folds of normal upper limitserum creatine <1.5 folds of normal upper limit; 9. predicted survival time more than 3 months.

Exclusion criteria

Exclusion criteria: 1. pregnant or breast-feeding women; 2. allergic to fluorouracil or paclitaxel or metabolic disorders; 3. organ transplantation history (including autologous bone marrow transplantation and l peripheral stem cell transplantation); 4. long systemic therapy history of steroids (note: withdraw >2 weeks after short drug history could be included); 5. Cerebral metastasic focus with manifestation; 6. with peripheral and central nervous system dysfunction or evident mental disorder; 7. with severe infection in need of treatment; 8. Participants with dysphagia, active gastric ulcer, partial intestinal obstruction, active gastrointestinal tract bleeding and perforation; 9. severe liver disease (such as cirrhosis), renal disease, respiratory disease or refractory diabetes; 10. with other malignant cancer failed to cure; 11. obvious EKG abnormality or heart disease with significant clinical manifestation such as congestive heart failure, coronary heart disease with manifestation, refractory cardiac arrhythmia, hypertension, or myocardial infarction attack in 12 months, or heart function rank III or IV.

Design outcomes

Primary

Measure	Time frame
Time to progression(TTP);	—

Secondary

Measure	Time frame
Efficacy (ORR);Safety;	—

Countries

China

Contacts

Public ContactLin Shen, Maolin Jin

lin100@medmail.com.cn+86 10-88196561

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026