Status:
UNKNOWN
A Feasibility Study for Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in ELM Gastric Cancer
Lead Sponsor:
The First Affiliated Hospital of Zhejiang Chinese Medical University
Collaborating Sponsors:
Zhejiang Cancer Hospital
Fujian Cancer Hospital
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The prognosis of Extensive lymph nodes metastatic(ELM) gastric cancer is poor. Chemotherapy occasionally converts it to a resectable cancer. Previous studies showed patients with ELM gastric cancer ma...
Detailed Description
The investigators will apply SPA regimen for coversional therapy to abtain high response rate. Paclitaxel：150 mg/m2 i.v.3h , given on the first day. Apatinib, oral ,initial dose :425mg, QD, after meal...
Eligibility Criteria
Inclusion
- ELM gastric cancer as proven histologically under following condition: unable radical excision due to the abdominal aorta a2-b1 or extensive lymph nodes metastatic,
- Definitely diagnosed as above stage of gastric cancer before operation via CT of MRI, ultrasonic endoscopy, PET-CT, or through the laparoscopic exploration if necessary
- Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
- Negative HER-2 state
- ECOG(Eastern Cooperative Oncology Group): 0\~2
- Age: 18\~70 years old- survival time \> 3monts
- Normal hemodynamic indices before the recruitment(including blood cell count and liver/kidney function ). For example: WBC\>4.0\*109/ L, NE\>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 years, and controllable hypertension and other coronary heart disease
- Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver)
- Not participating in other clinical trials before and during the treatment
- Signed the Informed Consent Form
- No peritoneal metastatic and CY0 in 28 days by laparoscopic exploration
- Non-gastric stump cancer
- No esophagus infiltrating or infiltrating less than 3cm
Exclusion
- Distal metastasis to Mediastinal lymph node,liver ,peritoneal,pleural effusion ,ascites,above 16a2-b1 and others
- Severe mental illness
- Her-2 positive, desire for hercptin treatment
- Ever administrated with other drugs(including TCM drugs) before the recruitment, or no guarantee of progress according to the study requirement after recruitment
- Allergy to the drugs in this protocol
- Pregnant and lactating women
- Women at childbearing age and of pregnancy desire during the study
Key Trial Info
Start Date :
August 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 22 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03258034
Start Date
August 24 2017
End Date
October 22 2021
Last Update
August 22 2017
Active Locations (1)
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1
The first affiliated hospital of zhejiang chinese medical university
Hanzhou, Zhejiang, China, 310006