Apatinib for Resectable Colorectal Cancer

Apatinib With Postoperative Adjuvant Chemotherapy for Operable Colorectal Cancer

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

Language: English.

Study Overview

• Status: Withdrawn
• Conditions: Colorectal Cancer; Surgery; Outcome, Fatal; Adjuvant Chemotherapy; Apatinib
• Intervention / Treatment: Drug: Apatinib; Drug: CAPEOX

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Nanchong, Sichuan, China, 637000
      • Yunhong Tian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. ECOG performance status score: 0-1.
2. All colorectal cancer patients underwent curative intent surgery
3. 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.
4. Patients who did not receive other treatments for colorectal adenocarcinoma after surgery;

5. 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:

     • total bilirubin ≤ 1.5 × ULN (normal upper limit);
     • alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2 × ULN;
     • Endogenous creatinine clearance ≥ 60 ml / min (Cockcroft-Gault formula);
   • Cardiac Doppler Ultrasonography: Left ventricular ejection fraction (LVEF) ≥ 50%.
6. The surgical incision has been healed, and no bleeding tendency;
7. Sign informed consent;
8. Compliance is good, family members agreed to accept survival follow-up.

Exclusion Criteria:

1. Patients with other malignancies, except for cured skin basal cell carcinoma and cervical cancer in situ.
2. Participated in other drug clinical trials within four weeks.
3. Have a variety of factors that affect oral medication (such as unable to swallow, chronic diarrhea and intestinal obstruction, etc.).
4. Have a history of bleeding, screening within 4 weeks before any serious grade to CTCAE4.0 3 degrees or more bleeding events.
5. 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.
6. 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.
7. Urinary protein ≥ ++ and urine protein> 1.0 g in 24 hours.
8. Patients with anastomotic fistula, pancreatic fistula or anastomotic stenosis and other serious postoperative complications.
9. Long-term non-healing wounds or bone fractures.
10. history of organ transplantation.
11. Imaging shows that the tumor has involved important vascular. Patients in high risk of fatal bleeding during treatment.
12. coagulation abnormalities, with bleeding tendency (14 days before randomization must meet: in the absence of anticoagulants, INR in normal range). application of anticoagulants or vitamin K antagonists such as warfarin, (1 mg orally, once daily) or low-dose aspirin (1 mg or less daily) at a prokaryotic time (INR) ≤ 1.5 Daily consumption of not more than 100 mg).
13. During the last year, the history of tachycardia / venous thrombosis events, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis (due to pre-chemotherapy intravenous thrombosis caused by intravenous thrombosis which have been cured ) And pulmonary embolism.
14. previous thyroid dysfunction, thyroid function can not be maintained within the normal range during medication.
15. with a history of psychiatric drug abuse and can not be prevented or have mental disorders.
16. Have a history of immunodeficiency, or suffer from other acquired, congenital immunodeficiency disease, or organ transplant history.
17. According to the researcher's judgment, there is a serious risk of compromising the patient's safety or affecting the patient's completion of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Apatinib; Apatinib combine with CAPEOX adjuvant chemotherapy for resectable colorectal; Other Names: YN968D1
PLACEBO_COMPARATOR: 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.	Drug: CAPEOX; CAPEOX adjuvant chemotherapy for resectable colorectal; Other Names: adjuvant chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants recurrence-free survival	Number of Participants recurrence-free survival in intervention group and control group.	1 year
Number of Participants overall survival	Number of Participants overall survival in intervention group and control group.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants recurrence-free survival	Number of Participants recurrence-free survival in intervention group and control group.	2 years
Number of Participants overall survival	Number of Participants overall survival in intervention group and control group.	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants recurrence-free survival	Number of Participants recurrence-free survival in intervention group and control group.	3 years
Number of Participants overall survival	Number of Participants overall survival in intervention group and control group.	3 years
Number of Participants recurrence-free survival	Number of Participants recurrence-free survival in intervention group and control group.	4 years
Number of Participants overall survival	Number of Participants overall survival in intervention group and control group.	4 years
Number of Participants recurrence-free survival	Number of Participants recurrence-free survival in intervention group and control group.	5 years
Number of Participants overall survival	Number of Participants overall survival in intervention group and control group.	5 years

Collaborators and Investigators

• Sponsor: Nanchong Central Hospital
• Investigators: Principal Investigator: Yunhong Tian, Nanchong central hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2020
• Primary Completion (ANTICIPATED): March 1, 2021
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: April 30, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (ACTUAL): July 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 31, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: surgery; Apatinib; Colorectal Cancer; adjuvant chemotherapy; Outcome, Fatal
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: Apatinib in Colorectal Surgery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No