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

NCT03258034 | Unknown Phase 2

• 1 other identifier: Ahead-G328
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

Conversion therapy

Outcome Measures

Primary Outcomes (1)

• 3 year OS

  The overall survival time

  3 years

Secondary Outcomes (4)

• radical resection rate

  4 months

• 3 year DFS

  3 years

• 5 year OS

  5 years

• adverse events

  7months

Study Arms (1)

Conversion treatment

EXPERIMENTAL

after 3-4 cycles S1/Paclitaxel chemotherapy plus Apatinib,subsequent surgery will be conducted with curative intent.

Drug: SPA

Interventions

SPA DRUG

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

Conversion treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead
• Zhejiang Cancer Hospital: collaborator
• Fujian Cancer Hospital: collaborator

Study Sites (1)

The first affiliated hospital of zhejiang chinese medical university

Hanzhou, Zhejiang, 310006, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Xiangdong Cheng, MD

  The First Affiliated Hospital of Zhejiang Chinese Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2017
• First Posted: August 22, 2017
• Study Start: August 24, 2017
• Primary Completion: August 22, 2020
• Study Completion: October 22, 2021
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)