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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03258034
Recruitment Status : Enrolling by invitation
First Posted : August 22, 2017
Last Update Posted : August 22, 2017
Sponsor:
Collaborators:
Zhejiang Cancer Hospital
Fujian Cancer Hospital
Information provided by (Responsible Party):
The First Affiliated Hospital of Zhejiang Chinese Medical University

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: SPA Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Convernsion Therapy Using S1/Paclitaxel Chemotherapy Plus Apatinib in ELM Gastric Cancer
Estimated Study Start Date : August 24, 2017
Estimated Primary Completion Date : August 22, 2020
Estimated Study Completion Date : October 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Conversion treatment
after 3-4 cycles S1/Paclitaxel chemotherapy plus Apatinib,subsequent surgery will be conducted with curative intent.
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




Primary Outcome Measures :
  1. 3 year OS [ Time Frame: 3 years ]
    The overall survival time


Secondary Outcome Measures :
  1. radical resection rate [ Time Frame: 4 months ]
    the radical resection rates

  2. 3 year DFS [ Time Frame: 3 years ]
    the diesease free survival time

  3. 5 year OS [ Time Frame: 5 years ]
    The overall survival time

  4. adverse events [ Time Frame: 7months ]
    number and degree of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258034


Locations
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China, Zhejiang
The first affiliated hospital of zhejiang chinese medical university
Hanzhou, Zhejiang, China, 310006
Sponsors and Collaborators
The First Affiliated Hospital of Zhejiang Chinese Medical University
Zhejiang Cancer Hospital
Fujian Cancer Hospital
Investigators
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Study Director: Xiangdong Cheng, MD The First Affiliated Hospital of Zhejiang Chinese Medical University
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Responsible Party: The First Affiliated Hospital of Zhejiang Chinese Medical University
ClinicalTrials.gov Identifier: NCT03258034    
Other Study ID Numbers: Ahead-G328
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The First Affiliated Hospital of Zhejiang Chinese Medical University:
Conversion therapy
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases