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Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients With Unresectable Gastric Cancer

Phase 2
18 Years
75 Years
Open (Enrolling)
Surgically-Created Resection Cavity, Drug Safety

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Trial Information

Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Creating the Operation Chance in the Patients With Unresectable Gastric Cancer

To assess the effectiveness and safety of S-1 + Paclitaxel for the peri-operative
chemotherapy in Chinese patients with unresectable gastric cancer, so as to further find out
the optimal protocol for the peri-operative chemotherapy in the patients with gastric

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

radical resection rate

Outcome Description:

radical resection rate

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

xiangdong Cheng, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Zhejiang Cancer Hospital


China: Food and Drug Administration

Study ID:




Start Date:

September 2011

Completion Date:

December 2016

Related Keywords:

  • Surgically-Created Resection Cavity
  • Drug Safety
  • Stomach Neoplasms