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WithdrawnNCT03228043Updated Nov 14, 2024

Apatinib for Resectable Colorectal Cancer

An interventional study of Apatinib and CAPEOX in Apatinib, Outcome, Fatal and Colorectal Cancer, sponsored by Nanchong Central Hospital. Withdrawn at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-14.

Sponsored by Nanchong Central Hospital · Not applicable, Interventional, and Treatment

Why this study was withdrawn
It's not possible to complete in our hospital.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Language: English.

02

Conditions studied

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

Keywords

  • Apatinib
  • Outcome, Fatal
  • Colorectal Cancer
  • surgery
  • adjuvant chemotherapy
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

Browse Colorectal Neoplasms studies →

Lead sponsor

Nanchong Central Hospital is the lead sponsor of 20 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugApatinib

    Apatinib combine with CAPEOX adjuvant chemotherapy for resectable colorectal

    Also known as: YN968D1

  • DrugCAPEOX

    CAPEOX adjuvant chemotherapy for resectable colorectal

    Also known as: adjuvant chemotherapy

06

What researchers measure

Primary outcomes

  1. Number of Participants recurrence-free survival

    Number of Participants recurrence-free survival in intervention group and control group.

    Time frame: 1 year

  2. Number of Participants overall survival

    Number of Participants overall survival in intervention group and control group.

    Time frame: 1 year

Secondary outcomes

  1. Number of Participants recurrence-free survival

    Number of Participants recurrence-free survival in intervention group and control group.

    Time frame: 2 years

  2. Number of Participants overall survival

    Number of Participants overall survival in intervention group and control group.

    Time frame: 2 years

Other outcomes

  1. Number of Participants recurrence-free survival

    Number of Participants recurrence-free survival in intervention group and control group.

    Time frame: 3 years

  2. Number of Participants overall survival

    Number of Participants overall survival in intervention group and control group.

    Time frame: 3 years

  3. Number of Participants recurrence-free survival

    Number of Participants recurrence-free survival in intervention group and control group.

    Time frame: 4 years

  4. Number of Participants overall survival

    Number of Participants overall survival in intervention group and control group.

    Time frame: 4 years

  5. Number of Participants recurrence-free survival

    Number of Participants recurrence-free survival in intervention group and control group.

    Time frame: 5 years

  6. Number of Participants overall survival

    Number of Participants overall survival in intervention group and control group.

    Time frame: 5 years

07

Study locations

1 site
  • Yunhong Tian
    Nanchong, Sichuan 637000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03228043
Lead sponsor
Nanchong Central Hospital
Responsible party
Yunhong Tian (Principal Investigator, Nanchong Central Hospital) — Principal investigator
First posted
Jul 24, 2017
Start date
Mar 1, 2020
Primary completion
Mar 1, 2021 (estimated)
Completion
Mar 1, 2023 (estimated)
Last update
Nov 14, 2024

Study contacts

Yunhong Tian
principal investigator · Nanchong Central Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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