Clinical trial · Interventional
Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Unresectable Gastric Cancer
Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients With Unresectable Gastric Cancer
NCT01756183CI-TRIAL-00008745unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Exploratory the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients with Unresectable Gastric Cancer
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Drug Safety | — | UNRESOLVED | — |
| Surgically-Created Resection Cavity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-1 + Paclitaxel Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- S-1 + Paclitaxel Chemotherapy
- description
- S-1: 60mg twice daily (after the breakfast and supper) for two weeks, and then suspend for one week. Paclitaxel: 150 mg/m2, iv, 3h, at D1
- interventionNames
- Drug: S-1 + Paclitaxel Chemotherapy
Primary outcomes (1)
- measure
- radical resection rate
- timeFrame
- 3 months
- description
- radical resection rate
Secondary outcomes (3)
- measure
- Adverse Events
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: -Unresectable gastric cancer as proven histologically (AJCC, Version 7) under any following condition: Unable radical excision due to the local metastasis or invasion Metastasis to the lymph node beside the abdominal aorta Non-extensive metastasis to liver (not more than three metastatic foci of radical excision) * Definitely diagnosed as above stage of stomach cancer before the operation via CT or MRI, ultrasonic endoscopy and blood tumor antigen test, or through the laparoscopy if necessary * Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy) * ECOG (Eastern Cooperative Oncology Group) : 0\~2 * Age: 18\~75 years old * Normal hemodynamic indices before the recruitment (including blood cell count and liver/kidney function). For example: WBC\>4.0×109/L, NEU \>1.5×109/L, PLT\>100×109/L, BIL\<1.5 times of upper limit of normal reference value, ALT and AST\<2.5 times of upper limit of normal reference value, and CRE\<1.2mg/dl * Good cardiac function before the recruitment, no seizure of myocardial infarction in past half year, and controllable hypertension and other coronary heart diseases * Not concomitant with other uncontrollable benign diseases before the recruitment (e.g. the infection in the lung, kidney and liver) * Not participating in other study projects before and during the treatment * Signed the Informed Consent Form Exclusion Criteria: * Not conforming to above inclusion criteria * Distal metastasis to lung, brain and bone (except the liver) * Ever operation on the stomach * Operation intolerance due to other systemic basic diseases * Ever administered other drugs (including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after the recruitment * Allergy to the drugs in this protocol * Pregnant or lactating women * Women at childbearing age and of pregnancy desire during the study
References
Publications (0)
Data not yet available
No reference posted for this study.