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

NCT ID: NCT02529878

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2019-08-31

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

conversion treatment

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

Group Type: EXPERIMENTAL

S1/Paclitaxel chemotherapy plus Apatinib

Intervention Type: DRUG

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

Interventions

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:500mg once daily

Intervention Type: DRUG

Other Intervention Names

SPA

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

The First Affiliated Hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiangdong Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhejiang Chinese Medical University

Locations

the First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiangdong Cheng, MD

Role: CONTACT

getfar@foxmail.com

+86-057187070965

Facility Contacts

Xiangdong Cheng, MD

Role: primary

getfar@foxmail.com

+86-057187970965

Other Identifiers

ECGC-0001

Identifier Type: -

Identifier Source: org_study_id