Esophageal Squamous Cell CarcinomaPhase 2NCT03387904
Study of Anlotinib Plus Irinotecan in Patients With Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Anlotinib Plus Irinotecan and Irinotecan in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
To compare the effects and safety of Anlotinib Plus Irinotecan versus Irinotecan in patients with esophageal squamous cell carcinoma(ESCC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Anlotinib Plus Irinotecan and Irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2019to 1 Dec 2022
- 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
- Histological documentation of esophageal squamous cell carcinoma;
- At least one measurable lesion (by RECIST1.1);
- Patients who have failed to a chemoradiation treatment;
- 18-75，ECOG PS:0-1,Life expectancy of more than 12 weeks;
- No treated with molecular targeted drugs;
- Main organs function is normal;
- Patients should participate in the study voluntarily and sign informed consent;
Who cannot join
- Allergic to anlotinib and/or its excipients;
- Patients with any severe and/or unable to control diseases，including：
- Blood pressure unable to be controlled ideally(systolic pressure >140 mmHg，diastolic pressure>90 mmHg);
- Patients with Grade 2 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥450ms for male， QT≥470ms for female) and patients with Grade 3 or higher congestive heart failure (NYHA Classification) or LVEF<50%;
- Patients with a clear Gastrointestinal bleeding tendency include the following situations: Local active ulcer lesions, and fecal occult blood (+ +) ; The patient had a history of black and hematemesis within 2 months;
- Patients with a bleeding tendency and INR>1.5,APTT>1.5 ULN ;
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- Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.);
- Patients with active brain metastasis, cancerous meningitis, spinal cord compression patients or found in Screening stage;
- Patients treated with VEGFR inhibitor;
- Patients with drug abuse history and unable to get rid of or Patients with mental disorders;
- Patients participated in other anticancer drug clinical trials within 4 weeks;
- Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Feng Wang, doctor
Qingxia Fan, doctor
About this study
Official title: A Randomized, Eploratory, Open Clinical Trial to Compare the Efficacy and Safety of Anlotinib Plus Irinotecan Versus Irinotecan in Patients With Esophageal Squamous Cell Carcinoma
To compare the effects and safety of Anlotinib Plus Irinotecan versus Irinotecan in patients with esophageal squamous cell carcinoma(ESCC).
Read the detailed description
In recent years, anti-angiogenic therapy has made some progress in the treatment of advanced esophageal squamous cell carcinoma.In clinical use, the efficacy of antiangiogenic monotherapy was low, with a median progression-free survival (PFS) of only 3 to 4 months.We conducted a randomized, open clinical Trial to evaluate efficacy and safety of anlotinib hydrochloride combined with irinotecan versus irinotecan monotherapy in patients with advanced esophageal squamous cell carcinoma.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Anlotinib Plus Irinotecan, Irinotecan
- Keywords
- Anlotinib
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib Plus IrinotecanDrug
Anlotinib QD po.and Irinotecan Day 1,8 ivgtt.
IrinotecanDrug
Irinotecan Day 1,8 ivgtt
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib Plus Irinotecan | Experimental | Anlotinib QD po.and Irinotecan Day 1,8 ivgtt. Both should be continued until disease progression or intolerable toxicity or patients withdrawal of consent Receives: Drug: Anlotinib Plus Irinotecan |
| Irinotecan | Active comparator | Irinotecan Day 1,8 ivgtt and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent Receives: Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress free survival (PFS)
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm.
Measured: up to 24 months
Disease Control Rate (DCR)
The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR
+ PR + SD)
Measured: up to 24 months
Secondary outcomes (5)
Overall Survival (OS)
The time from treatment initiation until death from any reason
Measured: up to 24 months
Objective Response Rate (ORR)
The proportion of patients with a confirmed complete response or partial response on two consecutive occasions≥4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: up to 24 months
Quality of life score
Each 42 days up to intolerance the toxicity or PD
Measured: up to 24 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Until initiation of new anticancer treatment
Measured: up to 24 months
NGS(Next Generation Sequencing) detecting
The sample for NGS detecting can be gotten form storage tumor tissue specimens. It must be better collecting the new tumor tissue specimens after tumor progress
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start13 Jan 2019
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Wang, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Feng Wang, doctor, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387904
- Sponsor's protocol ID
- ALTN-11-II-01
- Status last verified
- Aug 2021
- First submitted
- 23 Dec 2017
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Eploratory, Open Clinical Trial to Compare the Efficacy and Safety of Anlotinib Plus Irinotecan Versus Irinotecan in Patients With Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03387904
- Acronym / sponsor ID
- ALTN-11-II-01
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Anlotinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 13 Jan 2019 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 2 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.
To compare the effects and safety of Anlotinib Plus Irinotecan versus Irinotecan in patients with esophageal squamous cell carcinoma(ESCC).
Detailed description
In recent years, anti-angiogenic therapy has made some progress in the treatment of advanced esophageal squamous cell carcinoma.In clinical use, the efficacy of antiangiogenic monotherapy was low, with a median progression-free survival (PFS) of only 3 to 4 months.We conducted a randomized, open clinical Trial to evaluate efficacy and safety of anlotinib hydrochloride combined with irinotecan versus irinotecan monotherapy in patients with advanced esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib Plus Irinotecan | Experimental | Drug: Anlotinib Plus IrinotecanAnlotinib QD po.and Irinotecan Day 1,8 ivgtt. Both should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
| Irinotecan | Active comparator | Drug: IrinotecanIrinotecan Day 1,8 ivgtt and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histological documentation of esophageal squamous cell carcinoma;
- At least one measurable lesion (by RECIST1.1);
- Patients who have failed to a chemoradiation treatment;
- 18-75，ECOG PS:0-1,Life expectancy of more than 12 weeks;
- No treated with molecular targeted drugs;
Key exclusion criteria (12 listed)
- Allergic to anlotinib and/or its excipients;
- Patients with any severe and/or unable to control diseases，including：
- Patients with a clear Gastrointestinal bleeding tendency include the following situations: Local active ulcer lesions, and fecal occult blood (+ +) ; The patient had a history of black and hematemesis within 2 months;
- Patients with a bleeding tendency and INR>1.5,APTT>1.5 ULN ;
- Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.);
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 |
|---|---|---|
| Anlotinib Plus IrinotecanAnlotinib QD po.and Irinotecan Day 1,8 ivgtt. | Drug | Anlotinib Plus Irinotecan |
| IrinotecanIrinotecan Day 1,8 ivgtt | Drug | Irinotecan |
Primary outcome
Progress free survival (PFS)
Time frame: up to 24 months
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm.
Disease Control Rate (DCR)
Time frame: up to 24 months
The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR + PR + SD)
5 secondary outcomes
Overall Survival (OS)
Time frame: up to 24 months
Objective Response Rate (ORR)
Time frame: up to 24 months
Quality of life score
Time frame: up to 24 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: up to 24 months
NGS(Next Generation Sequencing) detecting
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
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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.
Feng Wang, doctor principal investigator
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib Plus Irinotecan and Irinotecan in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou University 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 7 inclusion and 12 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 2 Sep 2021. 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 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 Feng Wang, doctor (860013938244776, fengw010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress free survival (PFS) (time frame: up to 24 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 2 Sep 2021.