Research On the Optimized Treatment Method For Apatinib's Cure Of Advanced Gastric Cancer

The investigators hope that after this research, two different treatment methods' curative effects for advanced gastric cancer can be assessed. One is continuous use of apatinib, the other is 5 days' continuous use and 2 days' off of apatinib.

Study Overview

• Status: Unknown
• Conditions: Two Different Treatment Methods
• Intervention / Treatment: Drug: Apatinib

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: yifu he, doctor; Phone Number: 0551-65327666; Email: 834638033@qq.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Recruiting
      • Anhui Provincial Cancer Hospital
      • Contact: yifu he, doctor; Phone Number: 0551-65327666; Email: 834638033@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female patients,age≥18years
2. Confirmed by Pathology or histology of Gastric cancer
3. Patients who failed first-line chemotherapy
4. The ECOG physical status score:0 to 2
5. Expected survival ≥3months
6. Patients should be voluntary to the trail and provide with signed informed consent.
7. The researchers believe patients can benefit from the study.

Exclusion Criteria:

1. Pregnant or lactating women
2. Patients with a knowm history of allergic reactions and/ou hypersensitivity attributed to apatinib or its accessories
3. Patients with apatinib contraindications
4. Patients of doctors considered unsuitable for the trail

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apatinib 5 days' continuous use and 2 days' off; Apatinib 500mg 5 days' continuous use and 2 days' off with Docetaxel60mg/m2 to treat advanced gastric cancer	Drug: Apatinib; Apatinib 500mg with Docetaxel 60mg/m2
Active Comparator: Apatinib 500mg continuous use; Apatinib 500mg continuous use with Docetaxel60mg/m2 to treat advanced gastric cancer	Drug: Apatinib; Apatinib 500mg with Docetaxel 60mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progress free survival(PFS)	From data of randomization until the date of first dccumentde progression or date of death from any cause	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease control rate (DCR)	investigators will assess treatment response according to Response Evaluation Criteria in Soid Tumor	1year
Objective tumor response rate(ORR)	difined as the percentage of subjects having achieved confirmed Complete Response+Partial Response as best overall response according to radiological assessments	1year
overall survival (os)	difined as the length of time from random assignment to death or to last contact	1year
Quality of life score	a questionnaire developed to assess the quality of life of cancer patients	1 year
adverse events	adverse events are evaluated according to National Cancer institute Common Terminology Criteria for Adverse Events	1 year

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital
• Investigators: Study Chair: yifu He, doctor, Anhui Provincial Cancer Hospital

Publications and helpful links

General Publications

• Yan Y, Li H, Wu S, Wang G, Luo H, Niu J, Cao L, Hu X, Xu H, Jia W, Sun Y, Yao Y, Chen W, Ke L, Hu B, Ji C, Sun Y, Chen J, Li M, He Y. Efficacy and safety of intermittent versus continuous dose apatinib plus docetaxel as second-line therapy in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma: a randomized controlled study. Ann Transl Med. 2022 Feb;10(4):205. doi: 10.21037/atm-22-546.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: November 3, 2017
• First Submitted That Met QC Criteria: November 3, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 13, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: HYF001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No