Back to resultsA Feasibility Study for Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in ELM Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SPA
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Conversion therapy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- The first affiliated hospital of zhejiang chinese medical university
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Conversion treatment
Arm Description
after 3-4 cycles S1/Paclitaxel chemotherapy plus Apatinib,subsequent surgery will be conducted with curative intent.
Outcomes
Primary Outcome Measures
3 year OS
The overall survival time
Secondary Outcome Measures
radical resection rate
the radical resection rates
3 year DFS
the diesease free survival time
5 year OS
The overall survival time
adverse events
number and degree of adverse events
Full Information
NCT ID
NCT03258034
First Posted
August 20, 2017
Last Updated
August 21, 2017
Sponsor
The First Affiliated Hospital of Zhejiang Chinese Medical University
Collaborators
Zhejiang Cancer Hospital, Fujian Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03258034
Brief Title
A Feasibility Study for Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in ELM Gastric Cancer
Official Title
Phase II Study of Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in ELM Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 24, 2017 (Anticipated)
Primary Completion Date
August 22, 2020 (Anticipated)
Study Completion Date
October 22, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Zhejiang Chinese Medical University
Collaborators
Zhejiang Cancer Hospital, Fujian Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 may obtain a survival benefit from chemotherapy and subsequent curative surgery. The key of conversion therapy of ELMGC is the high response rate. Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. On the basis of our previous Ahead-G325 study, The purpose of this study is to investigate the efficacy and safety of S1/Paclitaxel chemotherapy plus Apatinib in the conversion therapys of ELM gastric cancer.
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 ( try to take the medicine at the same time of the day ). Dose adjustment: Down-regulate the dosage to 250 mg per day at the first time. If the patient totally recovers from the toxic reaction after the regulation, we could up-regulate the dosage back to the former level. If the downregulation occurs again according to the protocol , then the up-regulation will be forbidden.
S-1 dosage: According to the body surface area, the initial dosage of S-1 is decided by the following criteria. Take the medicine twice daily (after breakfast and supper) for 2 weeks, then suspend for 1 week. Preventive medication: To prevent serious allergic reaction of Paclitaxel, preventive medication should be given in advance. We usually give dexamethasone 20mg orally 12 and 6 hours before the Paclitaxel, and diphenhydramine (or something analogous) 50 mg, cimetidine 300mg (or ranitidine 50mg) I.V. 30-60 minutes before the Paclitaxel. Repeat the therapeutic schedule every 3 weeks. 3-4 cycles of neoadjuvant chemotherapy before surgery, stop Apatinib in the last cycle.4 cycles of adjuvant chemotherapy including S-1 and Apatinib 4 to 6 weeks after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Conversion therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conversion treatment
Arm Type
Experimental
Arm Description
after 3-4 cycles S1/Paclitaxel chemotherapy plus Apatinib,subsequent surgery will be conducted with curative intent.
Intervention Type
Drug
Intervention Name(s)
SPA
Intervention Description
S1/Paclitaxel chemotherapy plus Apatinib S1:60mg twice daily(after the breakfast and supper) for two weeks, and then suspend for one week Paclitaxel:150mg/m2,iv, 3h, at day1 Apatinib:425mg once daily
Primary Outcome Measure Information:
Title
3 year OS
Description
The overall survival time
Time Frame
3 years
Secondary Outcome Measure Information:
Title
radical resection rate
Description
the radical resection rates
Time Frame
4 months
Title
3 year DFS
Description
the diesease free survival time
Time Frame
3 years
Title
5 year OS
Description
The overall survival time
Time Frame
5 years
Title
adverse events
Description
number and degree of adverse events
Time Frame
7months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangdong Cheng, MD
Organizational Affiliation
The First Affiliated Hospital of Zhejiang Chinese Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The first affiliated hospital of zhejiang chinese medical university
City
Hanzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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A Feasibility Study for Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in ELM Gastric Cancer
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