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

Gastric Cancer Clinical Trial

Official title:

Phase II Study of Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in ELM Gastric Cancer

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03258034
• Other study ID #: Ahead-G328
• Status: Enrolling by invitation
• Phase: Phase 2
• First received: August 20, 2017
• Last updated: August 21, 2017
• Start date: August 24, 2017
• Est. completion date: October 22, 2021

Study information

• Verified date: August 2017
• Source: The First Affiliated Hospital of Zhejiang Chinese Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: October 22, 2021
• Est. primary completion date: August 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• SPA
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

Locations

Country	Name	City	State
China	The first affiliated hospital of zhejiang chinese medical university	Hanzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhejiang Chinese Medical University	Fujian Cancer Hospital, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 year OS	The overall survival time	3 years
Secondary	radical resection rate	the radical resection rates	4 months
Secondary	3 year DFS	the diesease free survival time	3 years
Secondary	5 year OS	The overall survival time	5 years
Secondary	adverse events	number and degree of adverse events	7months