Esophageal Squamous Cell CarcinomaPhase 2NCT03251417
Apatinib and Irinotecan Combination Treatment in Unresectable or Metastatic Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Irinotecan and Apatinib in people with Esophageal Squamous Cell Carcinoma, run by Peking University at 1 site in China.
Trial summary
Esophageal cancer is a common malignant disease worldwide especially in china. Though esophagectomy and definitive chemoradiotherapy are standard treatments, disease relapses in many patients and the prognosis of metastatic ESCC is still poor. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Irinotecan and Apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2017to 25 Apr 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years. Both genders are eligible.
- Patients must have histologically confirmed esophageal squamous cell carcinoma with unresectable or metastatic disease.
- With measurable or evaluable disease defined by RECIST 1.1 criteria by multi-slice spiral CT or MR scan.
- Failed in or disease progressed after fist-line chemotherapy (A. If failed in preoperative chemotherapy / chemoradiotherapy or disease progressed in 24 weeks after esophagectomy, the preoperative chemotherapy/ chemoradiotherapy is regard as first-line chemotherapy. B. If failed in definitive chemoradiotherapy or disease progressed in 24 weeks after definitive chemoradiotherapy, the definitive chemoradiotherapy is regard as first-line chemotherapy; C. If failed in or relapse in 24 weeks after adjuvant chemotherapy, the adjuvant chemotherapy is regard as first line chemotherapy).
- Patients must have a performance status of 0-2 on the ECOG scale.
- Life expectancy ≥3 months.
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- With normal marrow, liver and renal function:a hemoglobin (HGB) of ≥110g/L (without blood transfusion during 14 days); a neutrophil count of ≥2.0×109/L; a platelet count of ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL) or ≤3 UNL in case of liver metastasis. a creatinine (Cr) of ≤ 1.5 UNL or a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis. Fecal occult blood (-); Urine test: protein<(++) or <1.0g per 24 hours.
- Without bleeding and thrombosis disease.
- With normal coagulation function: APTT, PT and INR, each ≤ 1.5 ULN
- With normal electrocardiogram results and no history of congestive heart failure.
- Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug.
- With good compliance and agree to accept follow-up of disease progression and adverse events.
- With written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
Who cannot join
- Patients who have received irinotecan or apatinib in previous treatment.
- Other pathological type cancers of esophagus except for squamous cell carcinoma
- Uncontrolled hypertension (Treatment of antihypertensive drugs cannot reduced to the normal range: systolic pressure ≤140 mmHg and diastolic pressure ≤90 mmHg)
- With ≥grade 2 coronary heart disease, arrhythmia (including QTc interval prolongation male >450 ms, women >470 ms)
- Cannot take oral tables including uncontrolled vomiting, chronic diarrhea and intestinal obstruction.
- With potential bleeding risk of GI including (1) peptic ulcer and fecal occult blood (++ - +++); (2) melena or hematemesis history in last 3 months;(3) In case of fecal occult blood (+) or (+/-),fecal occult blood examination must be repeat in one week. If fecal occult blood is still (+) or (+/-),endoscopy is required and if there are ulcer or other diseases with bleeding risk in the opinion of the investigators. (4) Primary tumour lesion is of deep ulcer and in the opinion of the investigators may place the patient at risk of fetal bleeding or GI perforation.
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- Urine test: protein>(++) or >1.0g per 24 hours.
- With abnormal coagulation function (INR>1.5 ULN, APTT>1.5 ULN),
- With thrombosis or receiving anticoagulant treatment.
- With serious diseases such as congestive heart failure, uncontrolled myocardial infarction and arrhythmia, liver failure and renal failure.
- With brain metastasis
- Pregnant or lactated women.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Cancer Hospital / Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
About this study
Official title: Apatinib and Irinotecan Combination Treatment in Unresectable or Metastatic Esophageal Squamous Cell Carcinoma Patients Failed in First-line Chemotherapy: A Phase II Study
Esophageal cancer is a common malignant disease worldwide especially in china. Though esophagectomy and definitive chemoradiotherapy are standard treatments, disease relapses in many patients and the prognosis of metastatic ESCC is still poor. For patients with unresectable or metastatic ESCC, chemotherapy is an important treatment alone or with radiotherapy. Taxane, platinum, and fluoropyrimidine have been reported effective in ESCC and is used as first-line treatment of ESCC. As for 2nd-line treatment, both irinotecan and taxane had been recommended based on data from clinical trials which were most enrolled esophageal or esophageal-gastric junction adenocarcinoma and with only small sample size. Therefore, it is still urgently needed to explore effective 2nd-line treatment for ESCC.
Apatinib, also known as YN968D1, is an orally antiangiogenic agents. Preclinical and clinical data had shown that it is effective in the treatment of a variety of solid tumors including esophageal cancer. It had been approved as a 3rd-line treatment for patients with advanced gastric cancer by state FDA of China in 2014. And the safety data showed that hemorrhage is rare and non-fetal which is different from bevacizumab.
Therefore, the investigators initialize this phase II study to explore the efficacy and safety of irinotecan and apatinib combination treatment in unresectable or metastatic ESCC patients who failed in 1st-line chemotherapy or chemoradiotherapy.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Irinotecan, Apatinib
- Keywords
- Irinotecan, Apatinib
- 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.
IrinotecanDrug
Also called CPT-11
Irinotecan 150mg/m2, repeated very 2 weeks for 3 to 6 cycles.
ApatinibDrug
Also called YN968D1
Apatinib 500 mg oral take, daily
| Study group | Role | What they receive |
|---|---|---|
| Combination treatment | Experimental | Combination treatment of irinotecan and apatinib. Receives: Drug: Irinotecan; Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate
The percentage of patients with CR, PR, and SD response after 3 cycles' treatment according to RESIST v1.1 criteria.
Measured: From enrollment to 3 months after treatment.
Secondary outcomes (4)
Safety: All reported adverse events (NCI CTCAE 4.0 criteria)
All reported adverse events (NCI CTCAE 4.0 criteria) during treatment and one months after treatment.
Measured: From enrollment to progression of disease or 1 months after treatment.
Objective response rate
Clinical response rate of treatment (CR+PR) according to RESIST v1.1 criteria
Measured: From enrollment to 3 months after treatment
Median progression-free survival time
The length of time from enrollment until the time of progression of disease
Measured: From enrollment to progression of disease. Estimated time is about 4 months
Median overall survival time
The length of time from enrollment until the time of death.
Measured: From enrollment to death of patients, estimated about 8 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start10 Sep 2017
- Primary completion25 Apr 2021
- Study completion25 Apr 2021
Why it stopped: Because PD-1 antibodies had been proved to be a standard second-line treatment in esophageal cancer, the potential benefit of present intervention is under re-evaluation.
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 Peking 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute
- Responsible party
- Principal investigator, Xiaodong Zhang, Peking University Cancer Hospital & Institute
- Investigators
- Jun Jia, M.D., Principal investigator, Beijing Cancer Hospital/ Peking University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251417
- Sponsor's protocol ID
- AHEAD-HBE002
- Status last verified
- Jan 2023
- First submitted
- 14 Aug 2017
- Last updated
- 1 Feb 2023
- 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 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apatinib and Irinotecan Combination Treatment in Unresectable or Metastatic Esophageal Squamous Cell Carcinoma Patients Failed in First-line Chemotherapy: A Phase II Study
- ClinicalTrials.gov ID
- NCT03251417
- Acronym / sponsor ID
- AHEAD-HBE002
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Irinotecan, Apatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because PD-1 antibodies had been proved to be a standard second-line treatment in esophageal cancer, the potential benefit of present intervention is under re-evaluation.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 25 Apr 2021 (actual)
- Study completion
- 25 Apr 2021 (actual)
- First posted
- 16 Aug 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.
Esophageal cancer is a common malignant disease worldwide especially in china. Though esophagectomy and definitive chemoradiotherapy are standard treatments, disease relapses in many patients and the prognosis of metastatic ESCC is still poor. For patients with unresectable or metastatic ESCC, chemotherapy is an important treatment alone or with radiotherapy. Taxane, platinum, and fluoropyrimidine have been reported effective in ESCC and is used as first-line treatment of ESCC. As for 2nd-line treatment, both irinotecan and taxane had been recommended based on data from clinical trials which were most enrolled esophageal or esophageal-gastric junction adenocarcinoma and with only small sample size. Therefore, it is still urgently needed to explore effective 2nd-line treatment for ESCC.
Apatinib, also known as YN968D1, is an orally antiangiogenic agents. Preclinical and clinical data had shown that it is effective in the treatment of a variety of solid tumors including esophageal cancer. It had been approved as a 3rd-line treatment for patients with advanced gastric cancer by state FDA of China in 2014. And the safety data showed that hemorrhage is rare and non-fetal which is different from bevacizumab.
Therefore, the investigators initialize this phase II study to explore the efficacy and safety of irinotecan and apatinib combination treatment in unresectable or metastatic ESCC patients who failed in 1st-line chemotherapy or chemoradiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination treatment | Experimental | Drug: Irinotecan, Drug: ApatinibCombination treatment of irinotecan and apatinib. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18 to 70 years. Both genders are eligible.
- Patients must have histologically confirmed esophageal squamous cell carcinoma with unresectable or metastatic disease.
- With measurable or evaluable disease defined by RECIST 1.1 criteria by multi-slice spiral CT or MR scan.
- Failed in or disease progressed after fist-line chemotherapy (A. If failed in preoperative chemotherapy / chemoradiotherapy or disease progressed in 24 weeks after esophagectomy, the preoperative chemotherapy/ chemoradiotherapy is regard as first-line chemotherapy. B. If failed in definitive chemoradiotherapy or disease progressed in 24 weeks after definitive chemoradiotherapy, the definitive chemoradiotherapy is regard as first-line chemotherapy; C. If failed in or relapse in 24 weeks after adjuvant chemotherapy, the adjuvant chemotherapy is regard as first line chemotherapy).
- Patients must have a performance status of 0-2 on the ECOG scale.
Key exclusion criteria (12 listed)
- Patients who have received irinotecan or apatinib in previous treatment.
- Other pathological type cancers of esophagus except for squamous cell carcinoma
- Uncontrolled hypertension (Treatment of antihypertensive drugs cannot reduced to the normal range: systolic pressure ≤140 mmHg and diastolic pressure ≤90 mmHg)
- With ≥grade 2 coronary heart disease, arrhythmia (including QTc interval prolongation male >450 ms, women >470 ms)
- Cannot take oral tables including uncontrolled vomiting, chronic diarrhea and intestinal obstruction.
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 |
|---|---|---|
| IrinotecanAlso: CPT-11Irinotecan 150mg/m2, repeated very 2 weeks for 3 to 6 cycles. | Drug | Combination treatment |
| ApatinibAlso: YN968D1Apatinib 500 mg oral take, daily | Drug | Combination treatment |
Primary outcome
Disease control rate
Time frame: From enrollment to 3 months after treatment.
The percentage of patients with CR, PR, and SD response after 3 cycles' treatment according to RESIST v1.1 criteria.
4 secondary outcomes
Safety: All reported adverse events (NCI CTCAE 4.0 criteria)
Time frame: From enrollment to progression of disease or 1 months after treatment.
Objective response rate
Time frame: From enrollment to 3 months after treatment
Median progression-free survival time
Time frame: From enrollment to progression of disease. Estimated time is about 4 months
Median overall survival time
Time frame: From enrollment to death of patients, estimated about 8 months.
Results and safety
The study was stopped early (reason given: Because PD-1 antibodies had been proved to be a standard second-line treatment in esophageal cancer, the potential benefit of present intervention is under re-evaluation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- 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.
Jun Jia, M.D. principal investigator
Beijing Cancer Hospital/ Peking University Cancer Hospital
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 Irinotecan and Apatinib in people with Esophageal Squamous Cell Carcinoma, run by Peking 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 13 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: stopped early, as of the sponsor's last update on 1 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 was stopped early (reason given: Because PD-1 antibodies had been proved to be a standard second-line treatment in esophageal cancer, the potential benefit of present intervention is under re-evaluation.). 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?
Disease control rate (time frame: From enrollment to 3 months after treatment.). 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 1 Feb 2023.