Esophageal Squamous Cell CarcinomaPhase 2Poetry-1NCT02976896
Apatinib for Esophageal Squamous Cell Cancer After the Failure of Standard Treatment
A Phase 2 study testing Apatinib Mesylate in people with Esophageal Squamous Cell Carcinoma, run by Yuhong Li at 1 site in China.
Trial summary
We conduct the phase II clinical trial to further explore the efficacy and safety of Apatinib Mesylate in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments. 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?
- Apatinib Mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to 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
- Male or female patients, age:18-75 years old.
- The ECOG physical status score: 0 to 2.
- Confirmed by histology of recurrent or metastatic esophageal squamous cell carcinoma.
- Patients who previously received at least fluorouracil, platin or taxane-based palliative chemotherapy but failed(including patients who developed disease progression within half of a year after finishing their adjuvant or neoadjuvant chemotherapy) and patients who are intolerable or refuse to receive chemotherapy of agents mentioned above and develop disease progression within 2 months.
- Never received treatment of apatinib or any other anti-angiogenesis agent, such as sorafenib, sunitinib, bevacizumab, endostar etc.
- Lesions can be measured at single diameter by thoracic or abdominal computed tomography (CT) or magnetic resonance (MRI).Conventional methods should set at least 20mm as diameter or spiral CT 10 mm. Patients with increased or new lesions in radiotherapy area can be enrolled in the trial.
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- Expected survival ≥ 3 months.
- If the subject have received surgery, the operative wound should be completely healed and without bleeding tendency.
- Baseline of blood routine and biochemical routine should meet the following criteria:
- ANC≥1.5×10^9/L（1500/mm3）
- PLT≥75×10^9/L
- Hb≥9 g/dL
- Serum bilirubin levels no higher than 2 times the upper limit of normal value.
- AST and ALT no higher than 2.5 times the upper limit of normal value(no higher than 5 times the upper limit of normal value when patients developed liver metastasis).
- Serum creatinine no higher than 1.5 times the upper limit of normal value.
- No malabsorption or other gastrointestinal disorders that will affect drugs absorption.
- No severe complications such as active digestive tract hemorrhage, perforation, jaundice, gastrointestinal obstruction, non-cancerous fever > 38 ℃.
- Patients should be voluntary to the trial and provide with signed informed consent.
- Patients should have good compliance and cooperate with the evaluation of efficacy and adverse events and follow-ups according to the research plan.
Who cannot join
- Evidence of gastrointestinal bleeding tendency including: local active ulcer lesions with occult blood (+ +); melena and haematemesis within 2 months; possibilities of digestive tract hemorrhage.
- Evidence of hypertension that could not be controlled by drugs (SBP>140 mmHg, DBP>90 mmHg), grade I coronary heart disease, grade I arrhythmia(including QT interval prolonged by 450ms in male and 470ms in female) and grade I heart failure.
- Evidence of severe postoperative complications including intestinal obstruction, anastomotic fistula, pancreatic fistula and anastomotic stenosis.
- Evidence of urine protein ≥ (++) and 24 hours urinary protein quantitation >1.0 g.
- Fractures unhealed for long term or incompletely healed.
- Evidence of immunodeficiency disease, or other acquired or congenital immunodeficiency disease, or organ transplantation.
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- Evidence of coagulation disorders (INR>1.5, APTT>1.5 ULN), bleeding tendency(INR should be in normal value without anticoagulation 14 days before randomization), usage of anticoagulation or Vit K antagonist including warfarin, heparin or any other analogue. When INR≤ 1.5, small dosage of warfarin(1 mg p.o, qd) or Aspirin (dosage < 100mg/d) in preventive purpose is allowed.
- Evidence of arterial/venous thrombotic events within 1 year before inclusion, including cerebrovascular accident (including TIA), deep vein thrombosis( vein thrombosis caused by venous catheterization in previous chemotherapy is excluded) and pulmonary embolism.
- Known severe hypersensitivity to Apatinib or any of the excipients of this product
- Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
- CNS metastases without radiotherapy and/or surgery. Patients with treated CNS metastases may participate in this trial,except for those who must receive hormone therapy and those whose prior hormone therapy for CNS metastases is less than 4 weeks.
- psychiatric illness that would prevent the patient from giving informed consent
- Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, with the exception of nonmelanoma skin cancer or cervical carcinoma in situ
- Patient is concurrently using other approved or investigational antineoplastic agent
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Apatinib Mesylate in Recurrent/Metastatic Esophageal Squamous Cell Carcinoma After the Failure of Conventional Treatment: a Phase II Clinical Trial
We conduct the phase II clinical trial to further explore the efficacy and safety of Apatinib Mesylate in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments. An exploratory molecular marker analysis will be performed in order to find out the beneficial population of Apatinib Mesylate.
Read the detailed description
Esophageal cancer is one of the most common malignant tumor in China. In Asian countries, esophageal squamous cell carcinoma is the main pathological type of esophageal carcinoma. Prognosis of esophageal squamous cell carcinoma is usually poor and surgery is the only radical treatment. Cisplatin (DDP, cisplatin), 5 - Fluorouracil (5 - Fluorouracil, 5 - FU) and taxane are the most adopted chemotherapy agents, with efficacy rates of 33%-40% as first-line treatment for metastatic or recurrent esophageal squamous carcinoma and a median overall survival of 6-10 months. New agents were needed. Apatinib Mesylate is a small molecule VEGFR tyrosine kinase inhibitor. The anti-tumor mechanism of Apatinib is inhibiting angiogenesis in malignancy by inhibiting VEGFR. Apatinib Mesylate was approved by CFDA (China Food and Drug Administration) for the treatment of advanced gastric cancer. In the previous clinical practice, we observed that part of the patients with esophageal squamous cell carcinoma were resistant to conventional treatments benefited from Apatinib Mesylate. Based on the research situation mentioned above, we decided to conduct a phase II clinical trial to further explore the efficacy and safety of Apatinib Mesylate in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments. An exploratory molecular marker analysis will be performed in order to find out the beneficial population of Apatinib Mesylate.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Apatinib Mesylate
- 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.
Apatinib MesylateDrug
Patients will receive Apatinib Mesylate at 500mg/times,oral one times daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Apatinib Mesylate | Experimental | Patients will receive Apatinib Mesylate at 500mg/times,oral one times daily for 28 days. Receives: Drug: Apatinib Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate
Measured: 6 months
Secondary outcomes (5)
Overall survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Time to progression
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Incidence of Treatment-Emergent Adverse Events
Safety evaluation according to the CTCAE4.0 standard, once every 1 cycle assessment
Measured: Each follow up vist, assessed up to 12 months
Quality of life using EORTC QLQ C30 - scale
Life quality evaluation using EORTC QLQ C30 - scale，once every 1 cycle assessment
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Quality of life using esophageal special scale QLQ - OES18
Life quality evaluation using esophageal special scale QLQ - OES18, once every 1 cycle assessment
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2019
- Study completionDec 2022
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhong Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuhong Li, Sun Yat-sen University
- Investigators
- Li Yuhong, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976896
- Sponsor's protocol ID
- Poetry-1
- Acronym
- Poetry-1
- Status last verified
- Feb 2023
- First submitted
- 21 Nov 2016
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Apatinib Mesylate in Recurrent/Metastatic Esophageal Squamous Cell Carcinoma After the Failure of Conventional Treatment: a Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT02976896
- Acronym / sponsor ID
- Poetry-1 / Poetry-1
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Yuhong LiUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 29 Nov 2016 (estimated)
- 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.
We conduct the phase II clinical trial to further explore the efficacy and safety of Apatinib Mesylate in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments. An exploratory molecular marker analysis will be performed in order to find out the beneficial population of Apatinib Mesylate.
Detailed description
Esophageal cancer is one of the most common malignant tumor in China. In Asian countries, esophageal squamous cell carcinoma is the main pathological type of esophageal carcinoma. Prognosis of esophageal squamous cell carcinoma is usually poor and surgery is the only radical treatment. Cisplatin (DDP, cisplatin), 5 - Fluorouracil (5 - Fluorouracil, 5 - FU) and taxane are the most adopted chemotherapy agents, with efficacy rates of 33%-40% as first-line treatment for metastatic or recurrent esophageal squamous carcinoma and a median overall survival of 6-10 months. New agents were needed. Apatinib Mesylate is a small molecule VEGFR tyrosine kinase inhibitor. The anti-tumor mechanism of Apatinib is inhibiting angiogenesis in malignancy by inhibiting VEGFR. Apatinib Mesylate was approved by CFDA (China Food and Drug Administration) for the treatment of advanced gastric cancer. In the previous clinical practice, we observed that part of the patients with esophageal squamous cell carcinoma were resistant to conventional treatments benefited from Apatinib Mesylate. Based on the research situation mentioned above, we decided to conduct a phase II clinical trial to further explore the efficacy and safety of Apatinib Mesylate in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments. An exploratory molecular marker analysis will be performed in order to find out the beneficial population of Apatinib Mesylate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib Mesylate | Experimental | Drug: Apatinib MesylatePatients will receive Apatinib Mesylate at 500mg/times,oral one times daily for 28 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female patients, age:18-75 years old.
- The ECOG physical status score: 0 to 2.
- Confirmed by histology of recurrent or metastatic esophageal squamous cell carcinoma.
- Patients who previously received at least fluorouracil, platin or taxane-based palliative chemotherapy but failed(including patients who developed disease progression within half of a year after finishing their adjuvant or neoadjuvant chemotherapy) and patients who are intolerable or refuse to receive chemotherapy of agents mentioned above and develop disease progression within 2 months.
- Never received treatment of apatinib or any other anti-angiogenesis agent, such as sorafenib, sunitinib, bevacizumab, endostar etc.
Key exclusion criteria (15 listed)
- Evidence of gastrointestinal bleeding tendency including: local active ulcer lesions with occult blood (+ +); melena and haematemesis within 2 months; possibilities of digestive tract hemorrhage.
- Evidence of hypertension that could not be controlled by drugs (SBP>140 mmHg, DBP>90 mmHg), grade I coronary heart disease, grade I arrhythmia(including QT interval prolonged by 450ms in male and 470ms in female) and grade I heart failure.
- Evidence of severe postoperative complications including intestinal obstruction, anastomotic fistula, pancreatic fistula and anastomotic stenosis.
- Evidence of urine protein ≥ (++) and 24 hours urinary protein quantitation >1.0 g.
- Fractures unhealed for long term or incompletely healed.
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 MesylatePatients will receive Apatinib Mesylate at 500mg/times,oral one times daily for 28 days. | Drug | Apatinib Mesylate |
Primary outcome
Disease control rate
Time frame: 6 months
5 secondary outcomes
Overall survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Time to progression
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Incidence of Treatment-Emergent Adverse Events
Time frame: Each follow up vist, assessed up to 12 months
Quality of life using EORTC QLQ C30 - scale
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Quality of life using esophageal special scale QLQ - OES18
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: Yes
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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.
Li Yuhong, MD principal investigator
Sun Yat-sen 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 Apatinib Mesylate in people with Esophageal Squamous Cell Carcinoma, run by Yuhong Li 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 19 inclusion and 15 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: finished, as of the sponsor's last update on 16 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disease control rate (time frame: 6 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 16 Feb 2023.