Apatinib With Postoperative Adjuvant Chemotherapy for Operable Colorectal Cancer

Nanchong Central Hospital1 site in 1 countryMarch 1, 2020

ConditionsApatinib Outcome, Fatal Colorectal Cancer Surgery Adjuvant Chemotherapy

InterventionsApatinib CAPEOX

DrugsApatinib CAPEOX

Overview

Phase: Not Applicable
Intervention: Apatinib
Conditions: Apatinib
Sponsor: Nanchong Central Hospital
Locations: 1
Primary Endpoint: Number of Participants overall survival
Status: Withdrawn
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Objective: To compare the outcome of patients with colorectal cancer who treated with adjuvant therapy or Apatinib with adjuvant therapy postoperatively.

Language: English.

Registry

clinicaltrials.gov

Start Date

March 1, 2020

End Date

March 1, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nanchong Central Hospital

Responsible Party

Principal Investigator

Yunhong Tian

Principal Investigator

Nanchong Central Hospital

Eligibility Criteria

Inclusion Criteria

•ECOG performance status score: 0-
•All colorectal cancer patients underwent curative intent surgery
•Patients in stage Ⅱ(Any T, N0, M0) with multiple high-risk factors or stage Ⅲ (any T, N1-2, M0) which confirmed by pathology.
•Patients who did not receive other treatments for colorectal adenocarcinoma after surgery;
•The main organ function is good, patients must meet the following requirements with 14 days before using Apatinib:
•blood routine examination:
•hemoglobin\> 90 g / L (14 days without blood transfusion);
•neutrophil count\> 1.5 x 109 / L;
•platelet count\> 100 × 109 / L;
•biochemical examination:

Exclusion Criteria

•Patients with other malignancies, except for cured skin basal cell carcinoma and cervical cancer in situ.
•Participated in other drug clinical trials within four weeks.
•Have a variety of factors that affect oral medication (such as unable to swallow, chronic diarrhea and intestinal obstruction, etc.).
•Have a history of bleeding, screening within 4 weeks before any serious grade to CTCAE4.0 3 degrees or more bleeding events.
•Patients with central nervous system metastases or a history of central nervous system metastases before screening. For patients with suspected central nervous system metastases, CT or MRI examinations must be performed within 28 days prior to randomization to exclude central nervous system metastasis.
•History of high blood pressure can not be controlled with a single antihypertensive drug therapy (With a systolic blood pressure\> 140 mmHg, diastolic blood pressure\> 90 mmHg. A history of unstable angina within 3 months or a new diagnosis of angina within 6 months (Including QTcF: male ≥ 450 ms, female ≥470 ms) required long-term use of antiarrhythmic drugs and New York Heart Association classification ≥ Class II cardiac insufficiency.
•Urinary protein ≥ ++ and urine protein\> 1.0 g in 24 hours.
•Patients with anastomotic fistula, pancreatic fistula or anastomotic stenosis and other serious postoperative complications.
•Long-term non-healing wounds or bone fractures.
•history of organ transplantation.

Arms & Interventions

Apatinib group

Apatinib combined with CAPEOX program. Apatinib tablets: 500 mg po qd from the second cycle of chemotherapy. Oxaliplatin: Day 1, 130mg/m2, IV infusion. Capecitabine: Day 1-14, 1000mg/m2 Twice Daily, po. A total of 6 cycles, 3 weeks apart of chemotherapy.

Intervention: Apatinib

Control group

CAPEOX program. Oxaliplatin: Day 1, 130mg/m2, IV infusion. Capecitabine: Day 1-14, 1000mg/m2 Twice Daily, po. A total of 6 cycles, 3 weeks apart of chemotherapy.

Intervention: CAPEOX