HER-2 Positive Colorectal CancerPhase 1/2NCT04227041
A Study of Pyrotinib Combined With Capecitabine for Metastatic HER-2 Positive Colorectal Cancer
A Phase 1/2 study testing Pyrotinib in combination with capecitabine in people with HER-2 Positive Colorectal Cancer, run by Qingdao Zhixin Health Technology Co., Ltd. at 1 site in China.
Trial summary
To evaluate the efficacy and safety of pyrotinib combined with capecitabine in patients with metastatic her-2 positive colorectal cancer after standard treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HER-2 Positive Colorectal Cancer
- What is being tested?
- Pyrotinib in combination with capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2020to 10 Jan 2023
- Phase
- Phase 1/2
- 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
- Patients should be histologically diagnosed with metastatic CRC and after receiving at least two standard treatment regimens；
- Patients with HER2 positive；
- Metastatic colorectal cancer (stage Ⅳ, T1-4N0-2M1)；
- Life expectancy is at least 6 months
- ECOG score 0-1；
- The functional level of the major organs must meet the following requirements (no blood transfusion within 2 weeks prior to screening, no use of leukocytes or platelets)：
Who cannot join
- The histopathological type is mucinous adenocarcinoma or ovarian implant metastasis；
- Patients who have previously been treated with anti-Her2-targeted drugs；
- Patients with surgical opportunity or potential for surgical treatment；
- Patients with a high risk of bleeding or perforation due to a tumor that has apparently invaded adjacent organs (including large vessels) of the colorectal lesion or who have developed fistulas；
- Patients with any severe and/or uncontrolled disease;
- Patients with any or present brain metastases；
- Women who were pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-arm, Prospective, Open-label, Exploratory Study of Pyrotinib Combined With Capecitabine for Metastatic HER-2 Positive Colorectal Cancer Patients After at Least Second-line Standard Treatment
To evaluate the efficacy and safety of pyrotinib combined with capecitabine in patients with metastatic her-2 positive colorectal cancer after standard treatment.
- Conditions
- HER-2 Positive Colorectal Cancer
- Being tested
- Pyrotinib in combination with capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyrotinib in combination with capecitabineDrug
Also called Capecitabine
Pyrotinib in combination with capecitabine
| Study group | Role | What they receive |
|---|---|---|
| HER2 positive metastatic colorectal cancer | Experimental | Not described Receives: Drug: Pyrotinib in combination with capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximally Tolerated Dose (MTD)
Evaluation of tumor burden based on RECIST criteria.
Measured: up to 36 months
Progression-free survival (PFS)
Evaluation of tumor burden based on RECIST criteria.
Measured: up to 36 months
Secondary outcomes (4)
Objective Response Rate (ORR)
Evaluation of tumor burden based on RECIST criteria.
Measured: up to 36 months
Duration Of Response (DOR)
Evaluation of tumor burden based on RECIST criteria.
Measured: up to 36 months
Disease Control Rate (DCR)
Evaluation of tumor burden based on RECIST criteria.
Measured: up to 36 months
Incidence of Treatment-Emergent Adverse Events [Safety]
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start10 Jan 2020 (estimated)
- Primary completion10 Jan 2021 (estimated)
- Study completion10 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER-2 Positive 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao Zhixin Health Technology Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University
- Responsible party
- Principal investigator, Nailong Yang, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227041
- Sponsor's protocol ID
- QingdaoZHT
- Status last verified
- Jan 2020
- First submitted
- 10 Jan 2020
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- 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 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Prospective, Open-label, Exploratory Study of Pyrotinib Combined With Capecitabine for Metastatic HER-2 Positive Colorectal Cancer Patients After at Least Second-line Standard Treatment
- ClinicalTrials.gov ID
- NCT04227041
- Acronym / sponsor ID
- QingdaoZHT
- Conditions
- HER-2 Positive Colorectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Qingdao Zhixin Health Technology Co., Ltd.University, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University
- Study start
- 10 Jan 2020 (estimated)
- Primary completion
- 10 Jan 2021 (estimated)
- Study completion
- 10 Jan 2023 (estimated)
- First posted
- 13 Jan 2020 (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 evaluate the efficacy and safety of pyrotinib combined with capecitabine in patients with metastatic her-2 positive colorectal cancer after standard treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER2 positive metastatic colorectal cancer | Experimental | Drug: Pyrotinib in combination with capecitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients should be histologically diagnosed with metastatic CRC and after receiving at least two standard treatment regimens；
- Patients with HER2 positive；
- Metastatic colorectal cancer (stage Ⅳ, T1-4N0-2M1)；
- Life expectancy is at least 6 months
- ECOG score 0-1；
Key exclusion criteria (7 listed)
- The histopathological type is mucinous adenocarcinoma or ovarian implant metastasis；
- Patients who have previously been treated with anti-Her2-targeted drugs；
- Patients with surgical opportunity or potential for surgical treatment；
- Patients with a high risk of bleeding or perforation due to a tumor that has apparently invaded adjacent organs (including large vessels) of the colorectal lesion or who have developed fistulas；
- Patients with any severe and/or uncontrolled disease;
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 |
|---|---|---|
| Pyrotinib in combination with capecitabineAlso: CapecitabinePyrotinib in combination with capecitabine | Drug | HER2 positive metastatic colorectal cancer |
Primary outcome
Maximally Tolerated Dose (MTD)
Time frame: up to 36 months
Evaluation of tumor burden based on RECIST criteria.
Progression-free survival (PFS)
Time frame: up to 36 months
Evaluation of tumor burden based on RECIST criteria.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: up to 36 months
Duration Of Response (DOR)
Time frame: up to 36 months
Disease Control Rate (DCR)
Time frame: up to 36 months
Incidence of Treatment-Emergent Adverse Events [Safety]
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pyrotinib in combination with capecitabine in people with HER-2 Positive Colorectal Cancer, run by Qingdao Zhixin Health Technology Co., Ltd. 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 6 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 14 Jan 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Tao Jiang, Dr. (18661806663, jiangtao111@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximally Tolerated Dose (MTD) (time frame: up to 36 months). 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 Jan 2020.