NCT03377842

Brief Summary

Apatinib has been proved to be effective and safe among patients in advanced colorectal cancer in several trials. the investigators aimed to evaluate its efficacy and safety as the neoadjuvant therapy in real world practice, and to explore factors associated with efficacy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline
Completed

Started Jan 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 31, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

2.5 years

First QC Date

December 8, 2017

Last Update Submit

December 14, 2017

Conditions

Colorectal CancerNeoadjuvant Therapy

Keywords

apatinib

Outcome Measures

Primary Outcomes (2)

  • R0 ,R1 or R2 resection

    Number of patients (%) with hepatic metastases R0 ,R1 or R2 resection.

    at least 4-6 weeks after the end of chemotherapy

  • Progression-free survival (PFS)

    Progression-free survival is defined as the time from randomization to progression (RECIST v1.1 criteria) or death. Patients alive without progression will be censored at the last follow-up.

    8 months

Secondary Outcomes (2)

  • ORR(objective response rate)

    after 8 weeks

  • Overall survival (OS)

    14 months

Study Arms (2)

FOLFOX regimen

ACTIVE COMPARATOR

FOLFOX regime alone.

Drug: FOLFOX regimen

Apatinib and FOLFOX regimen

EXPERIMENTAL

Apatinib combine with FOLFOX regimen.

Drug: apatinib and FOLFOX regimen

Interventions

FOLFOX regimenDRUG

FOLFOX(Oxaliplatin 85 mg/m² IV infusion and leucovorin 200 mg/m² IV infusion， followed by Fluorouracil 400 mg/m² IV bolus , followed by Fluorouracil 600 mg/m²/h IV infusionas a 22-hour continuous infusion). Repeat cycle every 2 weeks for a total of 6 cycl

FOLFOX regimen
apatinib and FOLFOX regimenDRUG

Apatinib, 500mg p.o. qd, Repeat cycle every 2 weeks for a total of 6 cycles. FOLFOX regime, Repeat cycle every 2 weeks for a total of 6 cycles.

Apatinib and FOLFOX regimen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 18 years or older.
  • Histological or cytological confirmation of adenocarcinoma of the colon or/and rectum;
  • Stage TxNxM1 (truly metastatic disease) with liver metastases only.
  • Patients should be voluntary to the trial and provide with signed informed consent.
  • The researchers believe patients can benefit from the study.

You may not qualify if:

  • Patients with a known history of allergic reactions and/or hypersensitivity attributed to apatinib or its accessories.
  • Pregnant or lactating women
  • Patients with Apatinib contraindications
  • Patients of doctors considered unsuitable for the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.

    PMID: 26884585BACKGROUND

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Folfox protocolapatinib

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Gaoping Gaoping, doctor

    Sichuan province hospital

    STUDY CHAIR

Central Study Contacts

Gaoping Zhao, doctor

CONTACT

028-8739380549482795@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

December 8, 2017

First Posted

December 19, 2017

Study Start

January 31, 2018

Primary Completion

August 1, 2020

Study Completion

September 1, 2020

Last Updated

December 19, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share