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Study of Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in Unresectable Gastric Cancer

Primary Purpose

Gastric Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

S1/Paclitaxel chemotherapy plus Apatinib

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric caner, Apatinib, S1, conversion therapy, metastatic gastric cancer

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

unresectable gastric cancer as proven histologically(AJCC, version 7) under any following condition: unable radical excision due to the local metastasis of invasion metastasis to the lymph node beside the abdominal aorta, non-extensive metastasis to liver( not more than three metastatic foci of radical excision), Peritoneal metastasis(CY1,P1,P2), kukerburg tumor
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: 18~75 years old
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

Exclusion Criteria:

not conforming above inclusion conditions
Distal metastasis to lung, brain, and bone
Ever operation on the stomach
Operation intolerance due to other systemic basic disease
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 UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

conversion treatment

Arm Description

after 3 cycles S1/Paclitaxel chemotherapy plus Apatinib,subsequent surgery will be conducted with curative intent

Outcomes

Primary Outcome Measures

radical resection rate

the radical resection rates

Secondary Outcome Measures

overall survival

the overall survival time

adverse events

number and degree of adverse events

reaction rate

the reaction rate of chemotherapy

Full Information

NCT ID

NCT02529878

First Posted

August 19, 2015

Last Updated

July 23, 2016

Sponsor

The First Affiliated Hospital of Zhejiang Chinese Medical University

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02529878

Brief Title

Study of Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in Unresectable Gastric Cancer

Official Title

A Prospective Feasibility Study for Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in Unresectable Gastric Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

August 2015 (undefined)

Primary Completion Date

August 2016 (Anticipated)

Study Completion Date

August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital of Zhejiang Chinese Medical University

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The prognosis of metastatic gastric cancer is poor. Chemotherapy occasionally converts an initially unresectable gastric cancer to a resectable cancer. Previous studies showed patients with unresectable gastric cancer may obtain a survival benefit from chemotherapy and subsequent curative surgery. The key of conversion therapy of initially unresectable metastatic GC is the high response rate. Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. The purpose of this study is to investigate the efficacy and safety of S1/Paclitaxel chemotherapy plus Apatinib in the conversion therapys of metastatic 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 :500mg, 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 down-regulation 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 cycles of neoadjuvant chemotherapy before surgery, stop Apatinib in the last cycle. 3 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

gastric caner, Apatinib, S1, conversion therapy, metastatic gastric cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

conversion treatment

Arm Type

Experimental

Arm Description

after 3 cycles S1/Paclitaxel chemotherapy plus Apatinib,subsequent surgery will be conducted with curative intent

Intervention Type

Drug

Intervention Name(s)

S1/Paclitaxel chemotherapy plus Apatinib

Other Intervention Name(s)

SPA

Intervention Description

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:500mg once daily

Primary Outcome Measure Information:

Title

radical resection rate

Description

the radical resection rates

Time Frame

4 months

Secondary Outcome Measure Information:

Title

overall survival

Description

the overall survival time

Time Frame

3 years

Title

adverse events

Description

number and degree of adverse events

Time Frame

6 months

Title

reaction rate

Description

the reaction rate of chemotherapy

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: unresectable gastric cancer as proven histologically(AJCC, version 7) under any following condition: unable radical excision due to the local metastasis of invasion metastasis to the lymph node beside the abdominal aorta, non-extensive metastasis to liver( not more than three metastatic foci of radical excision), Peritoneal metastasis(CY1,P1,P2), kukerburg tumor 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: 18~75 years old 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 Exclusion Criteria: not conforming above inclusion conditions Distal metastasis to lung, brain, and bone Ever operation on the stomach Operation intolerance due to other systemic basic disease 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiangdong Cheng, MD

Phone

+86-057187070965

getfar@foxmail.com

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

Principal Investigator

Facility Information:

Facility Name

the First Affiliated Hospital of Zhejiang Chinese Medical University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310006

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiangdong Cheng, MD

Phone

+86-057187970965

getfar@foxmail.com

12. IPD Sharing Statement

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Study of Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in Unresectable Gastric Cancer

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