ApatinibNCT03228043
Apatinib for Resectable Colorectal Cancer
A study testing Apatinib and CAPEOX in people with Apatinib and Outcome, Fatal, run by Nanchong Central Hospital at 1 site in China.
Trial summary
Objective: To compare the outcome of patients with colorectal cancer who treated with adjuvant therapy or Apatinib with adjuvant therapy postoperatively. Language: English. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Apatinib, Outcome, Fatal, Colorectal Cancer
- What is being tested?
- Apatinib and CAPEOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 17Show fewer
- 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;
- Sign informed consent;
- Compliance is good, family members agreed to accept survival follow-up.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
- Have a history of immunodeficiency, or suffer from other acquired, congenital immunodeficiency disease, or organ transplant history.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Apatinib, Outcome, Fatal, Colorectal Cancer, Surgery, Adjuvant Chemotherapy
- Being tested
- Apatinib, CAPEOX
- Keywords
- Apatinib, Outcome, Fatal, Colorectal Cancer, surgery, adjuvant chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Also called YN968D1
Apatinib combine with CAPEOX adjuvant chemotherapy for resectable colorectal
CAPEOXDrug
Also called adjuvant chemotherapy
CAPEOX adjuvant chemotherapy for resectable colorectal
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: CAPEOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants recurrence-free survival
Number of Participants recurrence-free survival in intervention group and control group.
Measured: 1 year
Number of Participants overall survival
Number of Participants overall survival in intervention group and control group.
Measured: 1 year
Secondary outcomes (2)
Number of Participants recurrence-free survival
Number of Participants recurrence-free survival in intervention group and control group.
Measured: 2 years
Number of Participants overall survival
Number of Participants overall survival in intervention group and control group.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Mar 2020
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2023 (estimated)
Why it stopped: It's not possible to complete in our hospital.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApatinibStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanchong Central Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yunhong Tian, Nanchong Central Hospital
- Investigators
- Yunhong Tian, Principal investigator, Nanchong Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228043
- Sponsor's protocol ID
- Apatinib in Colorectal Surgery
- Status last verified
- Nov 2024
- First submitted
- 30 Apr 2017
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apatinib With Postoperative Adjuvant Chemotherapy for Operable Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03228043
- Acronym / sponsor ID
- Apatinib in Colorectal Surgery
- Conditions
- Apatinib, Outcome, Fatal, Colorectal Cancer, Surgery, Adjuvant Chemotherapy
- Keywords
- Apatinib, Outcome, Fatal, Colorectal Cancer, surgery, adjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It's not possible to complete in our hospital.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nanchong Central HospitalOther government
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To compare the outcome of patients with colorectal cancer who treated with adjuvant therapy or Apatinib with adjuvant therapy postoperatively.
Language: English.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apatinib group | Experimental | Drug: ApatinibApatinib 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. |
| Control group | Placebo comparator | Drug: CAPEOXCAPEOX 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApatinibAlso: YN968D1Apatinib combine with CAPEOX adjuvant chemotherapy for resectable colorectal | Drug | Apatinib group |
| CAPEOXAlso: adjuvant chemotherapyCAPEOX adjuvant chemotherapy for resectable colorectal | Drug | Control group |
Primary outcome
Number of Participants recurrence-free survival
Time frame: 1 year
Number of Participants recurrence-free survival in intervention group and control group.
Number of Participants overall survival
Time frame: 1 year
Number of Participants overall survival in intervention group and control group.
2 secondary outcomes
Number of Participants recurrence-free survival
Time frame: 2 years
Number of Participants overall survival
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Apatinib
RecruitingObservational study
Ablation of Pulmonary Oligometastasis Combined With System for Advanced Hepatocellular Carcinoma
Advanced Hepatocellular Carcinoma, Lung Cancer
Active, not recruitingPhase 2
KN046 Plus Regorafenib or Apatinib in MSI-H Digestive System Cancers Resistant to PD-1/PD-L1 Blockade
Digestive System Cancers
Not yet recruitingPhase 2
Retlirafusp Alfa Combined With Zeprumetostat, Apatinib, and Chemotherapy as First-Line Treatment for Metastatic GC/GEJC
Gastric Cancer/Gastroesophageal Junction Adenocarcinoma
RecruitingPhase 2/3
Hepatectomy Combined With Camrelizumab and Apatinib in CNLC Stage IIIb HCC
Hepatocellular Carcinoma
Active, not recruitingPhase 2
Carrelizumab, Chemotherapy and Apatinib in the Neoadjuvant Treatment of Resectable Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma, Neoadjuvant Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunhong Tian principal investigator
Nanchong Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apatinib and CAPEOX in people with Apatinib and Outcome, Fatal, run by Nanchong Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants recurrence-free survival (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.