Metastatic Colorectal CancerPhase 2NCT03132025
Study of Apatinib and Capecitabine Combination to Maintain Treating Metastatic Colorectal Cancer
A Phase 2 study testing "Apatinib" and "Capecitabine" and "Capecitabine" in people with Metastatic Colorectal Cancer, run by Yanqiao Zhang.
Trial summary
To control apatinib and capecitabine combination to maintain treating metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- "Apatinib" and "Capecitabine" and "Capecitabine"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2017to 30 Apr 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent form should be issued prior to conducting any research process;
- Men or women aged 18-75 years;
- Patients with advanced and / or metastatic colorectal cancer confirmed by histology or cytology;
- Patients who has not exposed to apatinib previously and had received oxaliplatin combined with fluorouracil chemotherapy;
- The estimated survival time is longer than 3 months;
- ECOG score was 0 or 1;
Show all 16Show fewer
- According to the RECIST v1.1 guidance, at least 1 lesion(who had not received radiotherapy) showed that the longest diameter≥10mm(except for lymph node, the short axis of the lymph node must be≥15mm) through CT or MRI(intravenous contrast agent was preferred ) accurate measurement and the lesion should be suitable for repeatable and accurate measurement; the lesion located in the previously irradiated area can be used as a measurable lesion if the lesion was proved in progress;
- With sufficient organ and bone marrow function, defined as follows:
- Hb≥9 g/dL
- Absolute neutrophil count ≥1.0 × 109 /L
- Platelet count≥75 × 109 /L
- Serum bilirubin ≤ 1.5 × ULN, which would not be appropriate for patients with Gilbert syndrome (Persistent or recurrent hyperbilirubinemia, mainly unconjugated bilirubin, with no evidence of hemolysis or abnormal liver pathology) which can consult a doctor
- ALT\&AST ≤ 2.5 × ULN; for patients with liver metastases, ALT\&AST ≤ 5 × ULN Calculate the creatinine clearance rate by Cockcroft-Gault formula
- Creatinine clearance rate measured( by actual body weight) or by measuring urine collection for 24 hours> 40 mL/min(the value of the measurement of the 24 - hour urine collection will be used to determine eligibility if the two methods are used)
- Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before inclusion, the results should be negative and they are willing to use the appropriate methods of contraception during the trial and within 6 months of the last experimental drug administration. Men should agree to use appropriate methods of contraception during the trial and within 6 months of the last experimental drug administration;
- Patients volunteered to participate in the trial and signed informed consent form with good compliance.
Who cannot join
- Patients with hypertension and can not be reduced to the normal range with antihypertensive drugs(systolic pressure >140 mmHg / diastolic pressure > 90 mmHg),patients with coronary heart disease more than grade II, arrhythmia (including QTc interval Prolongation men>450 ms, women >470 ms) and cardiac insufficiency;
- With a variety of factors affecting oral drugs(such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.);
- Special note: patients with the risk of gastrointestinal bleeding can not be included, including the following: active peptic ulcer lesions and fecal occult blood (+ +); patients with melena and hematemesis in 3 months; for patients with fecal occult blood (+) and primary gastric tumor without surgery should be carried out gastroscopy, patients with ulcero carcinoma of stomach and believed to cause the lesion to bleed by the physician;
- Abnormal coagulation function(INR>1.5×ULN、 APTT>1.5×ULN) with bleeding tendency;
- With Symptomatic central nervous system metastasis;
- Pregnant or lactating women;
- Other patients unsuitable for inclusion considered by the physician.
About this study
Official title: Phase 1 Study of Apatinib and Capecitabine Combination to Maintain Treating Metastatic Colorectal Cancer
To control apatinib and capecitabine combination to maintain treating metastatic colorectal cancer.
Read the detailed description
To control apatinib and capecitabine combination to maintain treating metastatic colorectal cancer,primary endpoint include in mPFS; secondary endpoint include in mOS, tolerance and security.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- "Apatinib" and "Capecitabine", "Capecitabine"
- Keywords
- Metastatic Colorectal Cancer, Apatinib, Capecitabine
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Apatinib" and "Capecitabine"Drug
Also called Arm A
Combine "Apatinib" and "Capecitabine" to Maintain Treating Metastatic Colorectal Cancer
"Capecitabine"Drug
Also called Arm B
Single Drug "Capecitabine" to Maintain Treating Metastatic Colorectal Cancer
| Study group | Role | What they receive |
|---|---|---|
| A: "apatinib" and "capecitabine" | Experimental | Arm A: "apatinib" and "capecitabine" apatinib 250mg qdpo; capecitabine 1000mg/m2 qdpo d1-14 q3w Receives: Drug: "Apatinib" and "Capecitabine" |
| B: "capecitabine" single drug | Active comparator | Arm B: "capecitabine" single drug "capecitabine" 1000mg/m2 qdpo d1-14 q3w Receives: Drug: "Capecitabine" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival of Patients with Apatinib and Capecitabine Combination That is prolonged
Patients with double drug group have more longer progression-free survival (PFS) than patients with single drug group
Measured: up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start30 Apr 2017 (estimated)
- Primary completion28 Feb 2018 (estimated)
- Study completion30 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanqiao Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanqiao Zhang, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132025
- Sponsor's protocol ID
- 045186298222
- Status last verified
- Apr 2017
- First submitted
- 16 Mar 2017
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Apatinib and Capecitabine Combination to Maintain Treating Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03132025
- Acronym / sponsor ID
- 045186298222
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Metastatic Colorectal Cancer, Apatinib, Capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yanqiao ZhangUniversity, hospital or other
- Study start
- 30 Apr 2017 (estimated)
- Primary completion
- 28 Feb 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 27 Apr 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.
To control apatinib and capecitabine combination to maintain treating metastatic colorectal cancer.
Detailed description
To control apatinib and capecitabine combination to maintain treating metastatic colorectal cancer,primary endpoint include in mPFS; secondary endpoint include in mOS, tolerance and security.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: "apatinib" and "capecitabine" | Experimental | Drug: "Apatinib" and "Capecitabine"Arm A: "apatinib" and "capecitabine" apatinib 250mg qdpo; capecitabine 1000mg/m2 qdpo d1-14 q3w |
| B: "capecitabine" single drug | Active comparator | Drug: "Capecitabine"Arm B: "capecitabine" single drug "capecitabine" 1000mg/m2 qdpo d1-14 q3w |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Informed consent form should be issued prior to conducting any research process;
- Men or women aged 18-75 years;
- Patients with advanced and / or metastatic colorectal cancer confirmed by histology or cytology;
- Patients who has not exposed to apatinib previously and had received oxaliplatin combined with fluorouracil chemotherapy;
- The estimated survival time is longer than 3 months;
Key exclusion criteria (7 listed)
- Patients with hypertension and can not be reduced to the normal range with antihypertensive drugs(systolic pressure >140 mmHg / diastolic pressure > 90 mmHg),patients with coronary heart disease more than grade II, arrhythmia (including QTc interval Prolongation men>450 ms, women >470 ms) and cardiac insufficiency;
- With a variety of factors affecting oral drugs(such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.);
- Special note: patients with the risk of gastrointestinal bleeding can not be included, including the following: active peptic ulcer lesions and fecal occult blood (+ +); patients with melena and hematemesis in 3 months; for patients with fecal occult blood (+) and primary gastric tumor without surgery should be carried out gastroscopy, patients with ulcero carcinoma of stomach and believed to cause the lesion to bleed by the physician;
- Abnormal coagulation function(INR>1.5×ULN、 APTT>1.5×ULN) with bleeding tendency;
- With Symptomatic 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 |
|---|---|---|
| "Apatinib" and "Capecitabine"Also: Arm ACombine "Apatinib" and "Capecitabine" to Maintain Treating Metastatic Colorectal Cancer | Drug | A: "apatinib" and "capecitabine" |
| "Capecitabine"Also: Arm BSingle Drug "Capecitabine" to Maintain Treating Metastatic Colorectal Cancer | Drug | B: "capecitabine" single drug |
Primary outcome
Progression-free Survival of Patients with Apatinib and Capecitabine Combination That is prolonged
Time frame: up to 10 months
Patients with double drug group have more longer progression-free survival (PFS) than patients with single drug group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Metastatic Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing "Apatinib" and "Capecitabine" and "Capecitabine" in people with Metastatic Colorectal Cancer, run by Yanqiao Zhang.
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 16 inclusion and 7 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 27 Apr 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?
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?
Progression-free Survival of Patients with Apatinib and Capecitabine Combination That is prolonged (time frame: up to 10 months). 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 27 Apr 2017.