Colorectal CancerPhase 2NCT03377842
Apatinib Treatment as the Neoadjuvant Therapy in Advanced Colorectal Cancer
A Phase 2 study testing FOLFOX regimen and apatinib and FOLFOX regimen in people with Colorectal Cancer and Neoadjuvant Therapy, run by Sichuan Provincial People's Hospital.
Trial summary
Apatinib has been proved to be effective and safe among patients in advanced colorectal cancer in several trials. the investigators aimed to evaluate its efficacy and safety as the neoadjuvant therapy in real world practice, and to explore factors associated with efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Neoadjuvant Therapy
- What is being tested?
- FOLFOX regimen and apatinib and FOLFOX regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2018to 1 Sep 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 years or older.
- Histological or cytological confirmation of adenocarcinoma of the colon or/and rectum;
- Stage TxNxM1 (truly metastatic disease) with liver metastases only.
- Patients should be voluntary to the trial and provide with signed informed consent.
- The researchers believe patients can benefit from the study.
Who cannot join
- Patients with a known history of allergic reactions and/or hypersensitivity attributed to apatinib or its accessories.
- Pregnant or lactating women
- Patients with Apatinib contraindications
- Patients of doctors considered unsuitable for the trial
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Real World Study of Efficacy and Safety for Apatinib Treatment as the Neoadjuvant Therapy in Advanced Colorectal Cancer
Apatinib has been proved to be effective and safe among patients in advanced colorectal cancer in several trials. the investigators aimed to evaluate its efficacy and safety as the neoadjuvant therapy in real world practice, and to explore factors associated with efficacy.
Read the detailed description
Regorafenib (BAY 73-4506, commercial name Stivarga) is an oral multi-kinase inhibitor developed by Bayer which shows anti-angiogenic activity due to its dual targeted VEGFR2-TIE2 tyrosine kinase inhibition.Regorafenib demonstrated to increase the overall survival of patients with metastatic colorectal cancer and has been approved by the CFDA in 2017.
Apatinib, a small molecule receptor tyrosine kinase (RTK) inhibitor, targets the intracellular domain of the VEGFR-2 ATP binding site, and is the first anti-angiogenic therapy approved by the China Food and Drug Administration in December 2014 for the treatment of metastatic gastric cancer in third-line or later treatment. It is an orally bioavailable, small molecule agent which is thought to inhibit angiogenesis in cancer cells; specifically apatinib inhibits VEGF-mediated endothelial cell migration and proliferation thus blocking new blood vessel formation in tumor tissue. It is an investigational cancer drug currently undergoing clinical trials as a potential targeted treatment for metastatic gastric carcinoma, metastatic breast cancer ,advanced hepatocellular carcinoma and advanced colorectal cancer.
Apatinib are often used in advanced colorectal cancer for uses that are not within its approved indication for use.However, the knowledge gained from all uses of apatinib in this medical practice is often not realized because the data collected are not systematically characterized, aggregated, and analyzed in a way that can be relied upon to inform its further usage.
In some cases, a "traditional" clinical trial may be impractical or excessively challenging to conduct. Ethical issues regarding treatment assignment, and other similar challenges, may present themsevels when developing and attempting to execute a high quality clinical trial. Analyses of real-world data(RWD), using appropriate methods, may in some cases provide similar information with comparable or even superior characteristics to information collected and analyzed through a traditional clinical trial. For example, RWD collected using a randomized exposure assignment within a registry can provide a sufficient number of patients for powered subgroup analyses.
the investigators will evaluate the efficacy and safety for Apatinib combine with other chemotherapy regimens as the neoadjuvant therapy in advanced colorectal cancer in a real world study setting. This study leveraging RWD can potentially provide information on a wider patient population, thus providing information that cannot be obtained through a traditional clinical trial alone.
- Conditions
- Colorectal Cancer, Neoadjuvant Therapy
- Being tested
- FOLFOX regimen, apatinib and FOLFOX regimen
- Keywords
- apatinib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOX regimenDrug
FOLFOX(Oxaliplatin 85 mg/m² IV infusion and leucovorin 200 mg/m² IV infusion， followed by Fluorouracil 400 mg/m² IV bolus , followed by Fluorouracil 600 mg/m²/h IV infusionas a 22-hour continuous infusion). Repeat cycle every 2 weeks for a total of 6 cycl
apatinib and FOLFOX regimenDrug
Apatinib, 500mg p.o. qd, Repeat cycle every 2 weeks for a total of 6 cycles. FOLFOX regime, Repeat cycle every 2 weeks for a total of 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| FOLFOX regimen | Active comparator | FOLFOX regime alone. Receives: Drug: FOLFOX regimen |
| Apatinib and FOLFOX regimen | Experimental | Apatinib combine with FOLFOX regimen. Receives: Drug: apatinib and FOLFOX regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 ,R1 or R2 resection
Number of patients (%) with hepatic metastases R0 ,R1 or R2 resection.
Measured: at least 4-6 weeks after the end of chemotherapy
Progression-free survival (PFS)
Progression-free survival is defined as the time from randomization to progression (RECIST v1.1 criteria) or death. Patients alive without progression will be censored at the last follow-up.
Measured: 8 months
Secondary outcomes (2)
ORR(objective response rate)
The objective response rate (CR and PR) will be evaluated by the investigator with RECIST v1.1 criteria after 4 cycles.
Measured: after 8 weeks
Overall survival (OS)
Overall survival is defined as the time from randomization to death any cause or last follow-up news for patients alive (censored data).
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start31 Jan 2018 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Zhao gaoping, Sichuan Provincial People's Hospital
- Investigators
- Gaoping Gaoping, doctor, Study chair, Sichuan province hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377842
- Sponsor's protocol ID
- APTN-CRC-201712
- Status last verified
- Dec 2017
- First submitted
- 8 Dec 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.
PubMed 26884585
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Study of Efficacy and Safety for Apatinib Treatment as the Neoadjuvant Therapy in Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03377842
- Acronym / sponsor ID
- APTN-CRC-201712
- Conditions
- Colorectal Cancer, Neoadjuvant Therapy
- Keywords
- apatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 31 Jan 2018 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 19 Dec 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.
Apatinib has been proved to be effective and safe among patients in advanced colorectal cancer in several trials. the investigators aimed to evaluate its efficacy and safety as the neoadjuvant therapy in real world practice, and to explore factors associated with efficacy.
Detailed description
Regorafenib (BAY 73-4506, commercial name Stivarga) is an oral multi-kinase inhibitor developed by Bayer which shows anti-angiogenic activity due to its dual targeted VEGFR2-TIE2 tyrosine kinase inhibition.Regorafenib demonstrated to increase the overall survival of patients with metastatic colorectal cancer and has been approved by the CFDA in 2017.
Apatinib, a small molecule receptor tyrosine kinase (RTK) inhibitor, targets the intracellular domain of the VEGFR-2 ATP binding site, and is the first anti-angiogenic therapy approved by the China Food and Drug Administration in December 2014 for the treatment of metastatic gastric cancer in third-line or later treatment. It is an orally bioavailable, small molecule agent which is thought to inhibit angiogenesis in cancer cells; specifically apatinib inhibits VEGF-mediated endothelial cell migration and proliferation thus blocking new blood vessel formation in tumor tissue. It is an investigational cancer drug currently undergoing clinical trials as a potential targeted treatment for metastatic gastric carcinoma, metastatic breast cancer ,advanced hepatocellular carcinoma and advanced colorectal cancer.
Apatinib are often used in advanced colorectal cancer for uses that are not within its approved indication for use.However, the knowledge gained from all uses of apatinib in this medical practice is often not realized because the data collected are not systematically characterized, aggregated, and analyzed in a way that can be relied upon to inform its further usage.
In some cases, a "traditional" clinical trial may be impractical or excessively challenging to conduct. Ethical issues regarding treatment assignment, and other similar challenges, may present themsevels when developing and attempting to execute a high quality clinical trial. Analyses of real-world data(RWD), using appropriate methods, may in some cases provide similar information with comparable or even superior characteristics to information collected and analyzed through a traditional clinical trial. For example, RWD collected using a randomized exposure assignment within a registry can provide a sufficient number of patients for powered subgroup analyses.
the investigators will evaluate the efficacy and safety for Apatinib combine with other chemotherapy regimens as the neoadjuvant therapy in advanced colorectal cancer in a real world study setting. This study leveraging RWD can potentially provide information on a wider patient population, thus providing information that cannot be obtained through a traditional clinical trial alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFOX regimen | Active comparator | Drug: FOLFOX regimenFOLFOX regime alone. |
| Apatinib and FOLFOX regimen | Experimental | Drug: apatinib and FOLFOX regimenApatinib combine with FOLFOX regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of 18 years or older.
- Histological or cytological confirmation of adenocarcinoma of the colon or/and rectum;
- Stage TxNxM1 (truly metastatic disease) with liver metastases only.
- Patients should be voluntary to the trial and provide with signed informed consent.
- The researchers believe patients can benefit from the study.
Key exclusion criteria (4 listed)
- Patients with a known history of allergic reactions and/or hypersensitivity attributed to apatinib or its accessories.
- Pregnant or lactating women
- Patients with Apatinib contraindications
- Patients of doctors considered unsuitable for the trial
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 |
|---|---|---|
| FOLFOX regimenFOLFOX(Oxaliplatin 85 mg/m² IV infusion and leucovorin 200 mg/m² IV infusion， followed by Fluorouracil 400 mg/m² IV bolus , followed by Fluorouracil 600 mg/m²/h IV infusionas a 22-hour continuous infusion). Repeat cycle every 2 weeks for a total of 6 cycl | Drug | FOLFOX regimen |
| apatinib and FOLFOX regimenApatinib, 500mg p.o. qd, Repeat cycle every 2 weeks for a total of 6 cycles. FOLFOX regime, Repeat cycle every 2 weeks for a total of 6 cycles. | Drug | Apatinib and FOLFOX regimen |
Primary outcome
R0 ,R1 or R2 resection
Time frame: at least 4-6 weeks after the end of chemotherapy
Number of patients (%) with hepatic metastases R0 ,R1 or R2 resection.
Progression-free survival (PFS)
Time frame: 8 months
Progression-free survival is defined as the time from randomization to progression (RECIST v1.1 criteria) or death. Patients alive without progression will be censored at the last follow-up.
2 secondary outcomes
ORR(objective response rate)
Time frame: after 8 weeks
Overall survival (OS)
Time frame: 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Background: PubMed 26884585Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.
- descriptions about real world study issued by the FDALink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Gaoping Gaoping, doctor study chair
Sichuan province hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FOLFOX regimen and apatinib and FOLFOX regimen in people with Colorectal Cancer and Neoadjuvant Therapy, run by Sichuan Provincial People's Hospital.
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 5 inclusion and 4 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 19 Dec 2017. 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. 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 Gaoping Zhao, doctor (028-87393805, 49482795@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 ,R1 or R2 resection (time frame: at least 4-6 weeks after the end of chemotherapy). 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?
On the ClinicalTrials.gov record for NCT03377842, which also lists 1 linked publication.
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 19 Dec 2017.