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Esophageal Squamous Cell CarcinomaPhase 1NCT02645864

Apatinib and Irinotecan Combination Treatment in Esophageal Squamous Cell Carcinoma

A Phase 1 study testing Apatinib and Irinotecan in people with Esophageal Squamous Cell Carcinoma, run by Peking University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Esophageal cancer is one of the common malignant tumors. The annual incidence of esophageal squamous cell carcinoma is 260,000 with the mortality of 210,000 in China. Different from that in western countries, esophageal squamous cell carcinoma (ESCC) is still the dominant pathological type in China and account for… 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?
Apatinib and Irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
Jan 2016to Dec 2018
Phase
Phase 1
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

  • Patients must have histologically confirmed esophageal squamous cell carcinoma with relapse disease and the primary tumor have been surgically removed.
  • With measurable or evaluable disease defined by RECIST 1.1 criteria by multi-slice spiral CT or MRI scan.
  • - Failed in or disease progressed after fist-line chemotherapy (If failed in perioperative chemotherapy or disease progressed in 24 weeks after perioperative chemotherapy, the perioperative chemotherapy is regard as first-line chemotherapy )
  • - Patients must have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale
  • - Without serious system dysfunction and could tolerate chemotherapy.
  • - With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/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); a creatinine (Cr) of ≤ 1.5 UNL; 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.
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  • - Life expectancy ≥3 months
  • - With normal electrocardiogram results and no history of congestive heart failure.
  • - Without bleeding and thrombosis disease
  • - With normal coagulation function: activated partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN
  • - 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 written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
  • - With good compliance and agree to accept follow-up of disease progression and adverse events.

Who cannot join

  • Patients who have received irinotecan or apatinib in previous treatment.
  • Primary tumor is not resected.
  • Uncontrolled hypertension (after treatment with 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 corrected QT interval prolongation male >450 ms, women >470 ms)
  • Cannot take oral tables including uncontrolled vomiting, chronic diarrhea and intestinal obstruction.
  • With potential bleeding risk including (1) peptic ulcer and fecal occult blood (++); (2) melena or hematemesis history in last 3 months; (3) fecal occult blood (+) or (+/-) and endoscopy showed ulcer or other diseases with bleeding risk.
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  • 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 of tumor
  • Pregnant or lactated women (premenopausal women must give urine pregnancy test before enrollment).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: Apatinib and Irinotecan Combination as Second-line Treatment in Esophageal Squamous Cell Carcinoma: a Phase I Dose Escalation Study

Esophageal cancer is one of the common malignant tumors. The annual incidence of esophageal squamous cell carcinoma is 260,000 with the mortality of 210,000 in China. Different from that in western countries, esophageal squamous cell carcinoma (ESCC) is still the dominant pathological type in China and account for more than 95% cases in clinic. The prognosis of ESCC is very poor. About 50% of patients have advanced disease at diagnosis with a 5-year survival rate of only 5-7%. Though esophagectomy is standard treatment, disease will relapse in many patients.

For patients with unresectable or recurrent disease, chemotherapy is an important treatment alone or with radiotherapy. Taxane, platinum, and fluoropyrimidine have been reported effective in ESCC and is popularly used in first-line treatment of ESCC. However, there is still no standard 2nd-line treatment for patients who fail in first-line treatment. Both irinotecan and taxane had been studied as 2nd-line treatment for esophageal cancer patients. But there are only a few of ESCC patients involved in those studies.

Read more

Except for chemotherapy, targeting treatment is another promising treatment for esophageal cancer. In recent years, antiangiogenic treatment has been proved to be effective and tolerable in many cancers such lung, colorectal, and gastric cancer. Apatinib is an also known as YN968D1, is an orally antiangiogenic agents. Preclinical and clinical data has shown that it is effective in the treatment of a variety of solid tumors including esophageal cancer. And it was approved and launched in China in 2014 as a 3rd-line treatment for patients with advanced gastric cancer.

Therefore, investigators initialize this dose escalation phase I study to explore the safety of irinotecan and apatinib combination treatment in ESCC patients with relapse disease after esophagectomy and failure in 1st-line chemotherapy. Investigators will analyze the maximum tolerated dose (MDT) and dose-limiting toxicity (DLT) in this study.

Being tested
Apatinib, Irinotecan
Keywords
Esophageal squamous cell carcinoma, Apatinib, Irinotecan
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.

  • ApatinibDrug

    Also called YN968D1

    250mg p.o. qd in first cohort (3 subjects). 250mg p.o. bid in second cohort (3 subjects) 250mg p.o. tid in third cohort (3 subjects)

  • IrinotecanDrug

    Also called Camptosar, Campto

    150mg/m^2 i.v. q2w

Study groups in NCT02645864
Study groupRoleWhat they receive
Apatinib and IrinotecanExperimentalThis study will include a sequential evaluation of 3 subjects per cohort. Cohort 1: apatinib 250 mg per day and irinotecan 150mg q2w. Cohort 2: apatinib 500 mg per day and irinotecan 150mg q2w. Cohort 3: apatinib 750 mg per day and irinotecan 150mg q2w. A dose limiting toxicity (DLT) event is defined as any of the following events: * CTCAE Grade 4 event * Grade 3 non-hematologic toxicity including fever, nausea, vomiting, and diarrhea that continues despite optimal medical management) If a DLT is experienced in any cohort, the cohort will be expanded to 6 subjects. If two (2) DLTs are experienced in any cohort, the study will stop and the dose of combination treatment in this cohort will be documented.
Receives: Drug: Apatinib; Drug: Irinotecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicity

    Dose limiting toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity according to NCI CTCAE 4.0 criteria.

    Measured: From enrollment to 1 months after completion of treatment. Estimated about 3 months.

  2. Maximum tolerance dose

    Maximum tolerance dose (MTD) is the dose of treatment in the cohort where there are 2 cases of DTL reported.

    Measured: From enrollment to 1 months after completion of treatment. Estimated about 3 months.

Secondary outcomes (3)

  1. Objective response rate

    Definition of ORR: clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate).

    Measured: From enrollment to 3 months after treatment

  2. Progression-free survival

    Definition of PFS: The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).

    Measured: From enrollment to progression of disease. Estimated about 6 months.

  3. Overall survival

    Definition of OS: The length of time from enrollment until the time of death (OS, overall survival).

    Measured: From enrollment to death of patients. Estimated about 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionDec 2018
  4. Study completionDec 2018

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02645864
Sponsor's protocol ID
AHEAD-HBE001
Status last verified
Apr 2017
First submitted
23 Dec 2015
Last updated
18 Mar 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Apatinib and Irinotecan 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 11 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 18 Mar 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 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.

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?

Dose limiting toxicity (time frame: From enrollment to 1 months after completion of treatment. Estimated about 3 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?

On the ClinicalTrials.gov record for NCT02645864.

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 18 Mar 2021.

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