Apatinib for Resectable Colorectal Cancer

NCT03228043 | Withdrawn DMC

• 1 other identifier: Apatinib in Colorectal Surgery
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Apatinib; Outcome, Fatal; Colorectal Cancer; Surgery; Adjuvant Chemotherapy

Keywords

Apatinib; Outcome, Fatal; Colorectal Cancer; surgery; adjuvant chemotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Number of Participants recurrence-free survival

  2 years

• Number of Participants overall survival

  2 years

Other Outcomes (6)

• Number of Participants recurrence-free survival

  3 years

• Number of Participants overall survival

  3 years

• Number of Participants recurrence-free survival

  4 years

Study Arms (2)

Apatinib group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

Apatinib DRUG

Apatinib combine with CAPEOX adjuvant chemotherapy for resectable colorectal

Also known as: YN968D1

Apatinib group

CAPEOX DRUG

CAPEOX adjuvant chemotherapy for resectable colorectal

Also known as: adjuvant chemotherapy

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG performance status score: 0-1.
• 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:
• 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%.
• The surgical incision has been healed, and no bleeding tendency;

You may not qualify if:

• 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.
• Imaging shows that the tumor has involved important vascular. Patients in high risk of fatal bleeding during treatment.
• 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).
• 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.
• previous thyroid dysfunction, thyroid function can not be maintained within the normal range during medication.
• with a history of psychiatric drug abuse and can not be prevented or have mental disorders.

Sponsors & Collaborators

• Nanchong Central Hospital: lead

Study Sites (1)

Yunhong Tian

Nanchong, Sichuan, 637000, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

apatinib; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Yunhong Tian

  Nanchong Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2017
• First Posted: July 24, 2017
• Study Start: March 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2023
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)