Esophageal NeoplasmsPhase 2NCT03787251
A Study of Second-line Treatment of Postoperative Recurrence and Metastasis of Esophageal Cancer Treated With Apatinib
A Phase 2 study testing Apatinib and The chemotherapeutic drug chosen by the investigator. in people with Esophageal Neoplasms, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial summary
A study of second-line treatment of postoperative recurrence and metastasis of esophageal squamous cell carcinoma after chemotherapy with apatinib mesylate Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- Apatinib and The chemotherapeutic drug chosen by the investigator.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 31 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological/histological diagnosis of esophageal squamous cell carcinoma; and at least one measurable lesion according to RECIST criteria (version 1.1);
- Patients who have undergone radical resection of esophageal cancer and who have failed after first-line systemic chemotherapy (which may include platinum, taxane or fluorouracil) after recurrence (recurrence of postoperative adjuvant chemotherapy within 6 months) Considered as first-line treatment, and the same progress in the field of radiation can be seen as recurrence;
- Age: 18-75 years old; both men and women;
- ECOG PS Rating: 0-1 points;
- Estimated survival period ≥ 3 months;
- ≥ 4 weeks from the last cytotoxic drug;
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- The main organs function normally, that is, meet the following criteria:
- Blood routine examination:
- HB≥90 g/L; (no blood transfusion within 14 days)
- ANC ≥ 1.5 × 109 / L;
- PLT ≥ 80 × 109 / L;
- Biochemical examinations must meet the following criteria:
- ALT and AST < 2.5 ULN; if there is liver metastasis, ALT and AST < 5 ULN;
- TBIL ≤ 1.5ULN;
- Plasma Cr≤1.5ULN or creatinine clearance (CCr)≥60ml/min
- Subjects volunteered to participate in the study, signed informed consent, and were well-adhered to follow-up.
- Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months of the end of the study; negative serum or urine pregnancy tests within seven days prior to study enrollment And must be non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period.
Who cannot join
- Those who have used anti-tumor angiogenesis drugs to treat failure;
- Patients with residual esophagus, residual stomach or anastomotic recurrence;
- Unable to swallow, chronic diarrhea and intestinal obstruction, which obviously affect the taking and absorption of drugs;
- Patients with brain metastases with symptoms or symptoms controlled for less than 3 months;
- Long-term unhealed wounds and fractures;
- Have clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood above ++), history of gastrointestinal bleeding within 6 months; coagulation abnormalities (PT>16 s, APTT>43 s, TT>21 s, Fbg< 2 g/L), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
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- Overactive/venous thrombosis occurred within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism;
- Imaging shows that the tumor has invaded the important perivascular circumference or that the patient is likely to invade the important blood vessels during the follow-up study and cause fatal bleeding.
- Persons with a history of psychotropic substance abuse who are unable to resolve or have a mental disorder;
- Participated in other clinical trials of anti-tumor drugs within four weeks;
- Have a history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation;
- According to the investigator's judgment, there are serious concomitant illnesses that compromise the safety of the patient or affect the patient's completion of the study.
- Patients with any severe and/or uncontrolled diseases, including:
- Blood pressure control is unreasonable (retraction pressure >150mmHg, diastolic pressure >100mmHg) Patients: I have myocardial ischemia or myocardial infarction above grade I, arrhythmia (including QT interval >440ms) and grade I cardiac insufficiency;
- Active or uncontrolled serious infections;
- Liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis;
- Poor diabetes control (fasting blood glucose FBG>10mmol/L);
- Urine routine indicates urinary protein >++, and confirmed 24-hour urine protein quantitation >1.0g.
- The investigator believes that it is not suitable for inclusion.
About this study
Official title: Randomized, Open, Positive Drug Control, Multicenter Clinical Study of Second-line Treatment of Postoperative Recurrence and Metastasis of Esophageal Squamous Cell Carcinoma With Chemotherapy in Patients Treated With Apatinib Mesylate
A study of second-line treatment of postoperative recurrence and metastasis of esophageal squamous cell carcinoma after chemotherapy with apatinib mesylate
Read the detailed description
This is a randomized, open-label, multi-center, phase II clinical trial initiated by a investigator to observe and evaluate the efficacy of apatinib in the treatment of patients with failed first-line treatment after recurrence and metastasis of esophageal squamous cell carcinoma. Effectiveness and security.
- Conditions
- Esophageal Neoplasms
- Being tested
- Apatinib, The chemotherapeutic drug chosen by the investigator.
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
It is recommended that the initial dose of apatinib is 500mg po qd. Adjust the dose to 750mg po qd or maintain the original dose according to the patient's medication response for about 2 weeks. If there is grade III or above, or grade II and above non-hematologic toxicity, allow the dose to be lowered 2 times.
The chemotherapeutic drug chosen by the investigator.Drug
The choice of chemotherapy regimen is based on the medication habits of the drug delivery doctor and the specific circumstances of the patient.
In addition, the following regimens may be selected as monotherapy or combination: docetaxel 60-75 mg/m2d1 q3w; irinotecan 150-180 mg/m2 d1 q2w until disease progression or patient death. If grade 3 and above or non-hematologic toxicity of grade II and above adverse event appeared, allowing the dose to be lowered twice.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | It is recommended that the initial dose of apatinib is 500mg po qd. Adjust the dose to 750mg po qd or maintain the original dose according to the patient's medication response for about 2 weeks. If there is grade III or above, or grade II and above non-hematologic toxicity, allow the dose to be lowered 2 times. Receives: Drug: Apatinib |
| Control group | Active comparator | The chemotherapeutic drug chosen by the investigator (if not used in the previous treatment regimen, it cannot be selected).
The choice of chemotherapy regimen is based on the medication habits of the drug delivery doctor and the specific circumstances of the patient.
In addition, the following regimens may be selected as monotherapy or combination: docetaxel 60-75 mg/m2d1 q3w; irinotecan 150-180 mg/m2 d1 q2w until disease progression or patient decease. If the adverse event grade 3 and above Or non-hematologic toxicity of grade II and above appeared, allowing the dose to be lowered twice. Receives: Drug: The chemotherapeutic drug chosen by the investigator. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: One year from admission
Secondary outcomes (3)
OS
Overall Survival
Measured: One year from admission
DCR
disease control rate
Measured: One year from admission
ORR
Objective Response Rate
Measured: One year from admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start1 Jan 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: In China, apatinib has been approved as an indication drug for esophageal squamous cell carcinoma, which makes it very difficult for our clinical trial to enroll patients. We regret that we failed to implement the design as planned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Ren, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787251
- Sponsor's protocol ID
- Nanjing Drum Tower Hospital
- Status last verified
- Jan 2019
- First submitted
- 20 Dec 2018
- Last updated
- 19 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open, Positive Drug Control, Multicenter Clinical Study of Second-line Treatment of Postoperative Recurrence and Metastasis of Esophageal Squamous Cell Carcinoma With Chemotherapy in Patients Treated With Apatinib Mesylate
- ClinicalTrials.gov ID
- NCT03787251
- Acronym / sponsor ID
- Nanjing Drum Tower Hospital
- Conditions
- Esophageal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: In China, apatinib has been approved as an indication drug for esophageal squamous cell carcinoma, which makes it very difficult for our clinical trial to enroll patients. We regret that we failed to implement the design as planned.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 26 Dec 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.
A study of second-line treatment of postoperative recurrence and metastasis of esophageal squamous cell carcinoma after chemotherapy with apatinib mesylate
Detailed description
This is a randomized, open-label, multi-center, phase II clinical trial initiated by a investigator to observe and evaluate the efficacy of apatinib in the treatment of patients with failed first-line treatment after recurrence and metastasis of esophageal squamous cell carcinoma. Effectiveness and security.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: ApatinibIt is recommended that the initial dose of apatinib is 500mg po qd. Adjust the dose to 750mg po qd or maintain the original dose according to the patient's medication response for about 2 weeks. If there is grade III or above, or grade II and above non-hematologic toxicity, allow the dose to be lowered 2 times. |
| Control group | Active comparator | Drug: The chemotherapeutic drug chosen by the investigator.The chemotherapeutic drug chosen by the investigator (if not used in the previous treatment regimen, it cannot be selected). The choice of chemotherapy regimen is based on the medication habits of the drug delivery doctor and the specific circumstances of the patient. In addition, the following regimens may be selected as monotherapy or combination: docetaxel 60-75 mg/m2d1 q3w; irinotecan 150-180 mg/m2 d1 q2w until disease progression or patient decease. If the adverse event grade 3 and above Or non-hematologic toxicity of grade II and above appeared, allowing the dose to be lowered twice. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Pathological/histological diagnosis of esophageal squamous cell carcinoma; and at least one measurable lesion according to RECIST criteria (version 1.1);
- Patients who have undergone radical resection of esophageal cancer and who have failed after first-line systemic chemotherapy (which may include platinum, taxane or fluorouracil) after recurrence (recurrence of postoperative adjuvant chemotherapy within 6 months) Considered as first-line treatment, and the same progress in the field of radiation can be seen as recurrence;
- Age: 18-75 years old; both men and women;
- ECOG PS Rating: 0-1 points;
- Estimated survival period ≥ 3 months;
Key exclusion criteria (19 listed)
- Those who have used anti-tumor angiogenesis drugs to treat failure;
- Patients with residual esophagus, residual stomach or anastomotic recurrence;
- Unable to swallow, chronic diarrhea and intestinal obstruction, which obviously affect the taking and absorption of drugs;
- Patients with brain metastases with symptoms or symptoms controlled for less than 3 months;
- Long-term unhealed wounds and fractures;
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 |
|---|---|---|
| ApatinibIt is recommended that the initial dose of apatinib is 500mg po qd. Adjust the dose to 750mg po qd or maintain the original dose according to the patient's medication response for about 2 weeks. If there is grade III or above, or grade II and above non-hematologic toxicity, allow the dose to be lowered 2 times. | Drug | experimental group |
| The chemotherapeutic drug chosen by the investigator.The choice of chemotherapy regimen is based on the medication habits of the drug delivery doctor and the specific circumstances of the patient. In addition, the following regimens may be selected as monotherapy or combination: docetaxel 60-75 mg/m2d1 q3w; irinotecan 150-180 mg/m2 d1 q2w until disease progression or patient death. If grade 3 and above or non-hematologic toxicity of grade II and above adverse event appeared, allowing the dose to be lowered twice. | Drug | Control group |
Primary outcome
PFS
Time frame: One year from admission
progression-free survival
3 secondary outcomes
OS
Time frame: One year from admission
DCR
Time frame: One year from admission
ORR
Time frame: One year from admission
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
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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.
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 The chemotherapeutic drug chosen by the investigator. in people with Esophageal Neoplasms, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
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 17 inclusion and 19 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: withdrawn, as of the sponsor's last update on 19 Apr 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
PFS (time frame: One year from admission). 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 19 Apr 2022.