Colorectal NeoplasmsPhase 2NCT03412994
Clinical Study of Apatinib Combined With Second - Line Chemotherapy for Metastatic Colorectal Cancer
A Phase 2 study testing Apatinib and standard second-line chemotherapy in people with Colorectal Neoplasms, run by Liqiang Zhong.
Trial summary
(1) Evaluate the efficacy of apatinib in combination with standard second-line chemotherapy for advanced colorectal cancer. Whether it can prolong Progression Free Survival (PFS), overall survival (OS) in patients with advanced colorectal cancer and reduce symptoms and improve quality of life compared with standard… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Apatinib and standard second-line chemotherapy
- 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
- 60 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2018to 28 Feb 2021
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 to 70 years old;
- Histologically or cytologically proven patients with metastatic colorectal cancer have undergone a first-line standard regimen recommended by the NCCN guidelines for progression;
- According to the RECIST 1.1 criteria, the patient has at least one target lesion that can measure the diameter;
- ECOG PS ≤ 2;
- Expected survival time of more than 12 weeks.
- The level of organ function must meet the following requirements:
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- Bone marrow: neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet ≥ 75 × 10^9/L, hemoglobin ≥ 90g/L.
- Liver: serum bilirubin ≤ 2 times the upper limit of normal, aminotransferase AST and ALT ≤ 2.5 times the normal upper limit.
- Kidney: Serum creatinine ≤1.5 times upper limit of normal.
- Patient compliance is good;
- Understand and voluntarily sign a written informed consent.
Who cannot join
- Other previous or concurrent malignancy, except cured skin basal cell carcinoma and cervical carcinoma in situ;
- Already known to be allergic to apatinib or any excipient;
- Use unapproved drugs or other test medications within 4 weeks prior to enrollment;
- There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- Patients with a history of CNS metastases or CNS metastases;
- A history of bleeding, with any serious grading within 4 weeks prior to screening reaching a bleeding event of 3 degrees Celsius or greater in CTCAE4.0;
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- Serious infection;
- Serious cardiovascular disease: uncontrolled hypertension, unstable angina, grade 3-4 heart failure (NYHA standard), congestive heart failure;
- urinary routine urinary protein ≥ ++ and confirmed 24-hour urinary protein quantitation> 1.0 g;
- Within 30 days after major surgery;
- Thrombotic disease. Anemia or venous thrombosis occurred in the previous year, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, pulmonary embolism, etc.;
- Those with history of psychotropic substance abuse who can not be abstinent or have mental disorders;
- Have clinical symptoms, need clinical intervention pleural effusion or ascites;
- At the investigator's discretion, there is a serious concomitant condition that compromises the patient's safety or affects the patient in completing the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Parallel-controlled, Exploratory Clinical Trial of Second-line Chemotherapy With Second-line Chemotherapy Versus Second-line Chemotherapy With Apatinib in the Treatment of Metastatic Colorectal Cancer
(1) Evaluate the efficacy of apatinib in combination with standard second-line chemotherapy for advanced colorectal cancer. Whether it can prolong Progression Free Survival (PFS), overall survival (OS) in patients with advanced colorectal cancer and reduce symptoms and improve quality of life compared with standard second-line chemotherapy; (2) Observe the safety of apatinib for the treatment of advanced colorectal cancer.
Read the detailed description
Standard second line chemotherapy includes chemotherapy based on irinotecan or chemotherapy based on oxaliplatin.
Apatinib is a small-molecule tyrosine kinase inhibitor (TKI) that highly selectively binds to and strongly inhibits vascular endothelial growth factor receptor 2 (VEGFR-2), with a decrease in VEGF-mediated endothelial cell migration, proliferation, and tumor microvascular density. A phase II trail of Apatinib has been demonstrated that Apatinib is safe to treat the metastatic colorectal cancer and the disease control rate can reach 50%.
- Conditions
- Colorectal Neoplasms
- Being tested
- Apatinib, standard second-line 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 in combination with standard second-line chemotherapy for advanced colorectal cancer
standard second-line chemotherapyDrug
Also called FOLFOX、FOLFIRI、CapeOX
The second line standard chemotherapy regimen recommended by the NCCN
| Study group | Role | What they receive |
|---|---|---|
| Apatinib group | Experimental | Apatinib combined with second-line chemotherapy (5-Fu combined with irinotecan or oxaliplatin standard regimen ) Apatinib tablets: 500 mg po qd . Continuous medication, the cycle is consistent with the chemotherapy cycle.
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.（Take CAPEOX for example） Receives: Drug: Apatinib; Drug: standard second-line chemotherapy |
| Control group | Placebo comparator | 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.（Take CAPEOX for example） Receives: Drug: standard second-line chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 4 weeks of therapy
Measured: Approximately 2 year
Secondary outcomes (4)
Overall survival (OS)
Defined as the time from randomize to death
Measured: Approximately 3 years
Objective Response Rate (ORR)
ORR=complete response (CR) + partial response (PR)
Measured: Approximately 2 years
Disease control rate(DCR)
Defined as the rate of complete response , partial response and stable disease according to RECIST guidelines
Measured: Approximately 2 years
Quality of life(QoL)
As measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30)
Measured: Approximately 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start28 Feb 2018 (estimated)
- Primary completion28 Feb 2020 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liqiang Zhong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liqiang Zhong, The Second People's Hospital of Yibin
- Investigators
- Liqiang Zhong, Study chair, Yibin Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412994
- Sponsor's protocol ID
- ChiCTR1800014478
- Status last verified
- Jan 2018
- First submitted
- 22 Jan 2018
- Last updated
- 29 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-controlled, Exploratory Clinical Trial of Second-line Chemotherapy With Second-line Chemotherapy Versus Second-line Chemotherapy With Apatinib in the Treatment of Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03412994
- Acronym / sponsor ID
- ChiCTR1800014478
- Conditions
- Colorectal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Liqiang ZhongUniversity, hospital or other
- Study start
- 28 Feb 2018 (estimated)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 29 Jan 2018 (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.
(1) Evaluate the efficacy of apatinib in combination with standard second-line chemotherapy for advanced colorectal cancer. Whether it can prolong Progression Free Survival (PFS), overall survival (OS) in patients with advanced colorectal cancer and reduce symptoms and improve quality of life compared with standard second-line chemotherapy; (2) Observe the safety of apatinib for the treatment of advanced colorectal cancer.
Detailed description
Standard second line chemotherapy includes chemotherapy based on irinotecan or chemotherapy based on oxaliplatin.
Apatinib is a small-molecule tyrosine kinase inhibitor (TKI) that highly selectively binds to and strongly inhibits vascular endothelial growth factor receptor 2 (VEGFR-2), with a decrease in VEGF-mediated endothelial cell migration, proliferation, and tumor microvascular density. A phase II trail of Apatinib has been demonstrated that Apatinib is safe to treat the metastatic colorectal cancer and the disease control rate can reach 50%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apatinib group | Experimental | Drug: Apatinib, Drug: standard second-line chemotherapyApatinib combined with second-line chemotherapy (5-Fu combined with irinotecan or oxaliplatin standard regimen ) Apatinib tablets: 500 mg po qd . Continuous medication, the cycle is consistent with the chemotherapy cycle. 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.（Take CAPEOX for example） |
| Control group | Placebo comparator | Drug: standard second-line chemotherapyOxaliplatin: 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.（Take CAPEOX for example） |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female aged 18 to 70 years old;
- Histologically or cytologically proven patients with metastatic colorectal cancer have undergone a first-line standard regimen recommended by the NCCN guidelines for progression;
- According to the RECIST 1.1 criteria, the patient has at least one target lesion that can measure the diameter;
- ECOG PS ≤ 2;
- Expected survival time of more than 12 weeks.
Key exclusion criteria (14 listed)
- Other previous or concurrent malignancy, except cured skin basal cell carcinoma and cervical carcinoma in situ;
- Already known to be allergic to apatinib or any excipient;
- Use unapproved drugs or other test medications within 4 weeks prior to enrollment;
- There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction);
- Patients with a history of CNS metastases or CNS metastases;
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 in combination with standard second-line chemotherapy for advanced colorectal cancer | Drug | Apatinib group |
| standard second-line chemotherapyAlso: FOLFOX、FOLFIRI、CapeOXThe second line standard chemotherapy regimen recommended by the NCCN | Drug | Apatinib group, Control group |
Primary outcome
Progression-free survival (PFS)
Time frame: Approximately 2 year
the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 4 weeks of therapy
4 secondary outcomes
Overall survival (OS)
Time frame: Approximately 3 years
Objective Response Rate (ORR)
Time frame: Approximately 2 years
Disease control rate(DCR)
Time frame: Approximately 2 years
Quality of life(QoL)
Time frame: Approximately 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Liqiang Zhong study chair
Yibin Second People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib and standard second-line chemotherapy in people with Colorectal Neoplasms, run by Liqiang Zhong.
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 11 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liqiang Zhong (15283572951, zhongliqiang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Approximately 2 year). 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 29 Jan 2018.