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Esophageal TumorPhase 2NCT03800953

The Ave-CRT Study for Newly Diagnosed Metastatic Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Avelumab in people with Esophageal Tumor and Metastatic Esophageal Squamous Cell Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single institutional, single arm, open labeled phase II study to assess the overall radiographic response of adding Avelumab to chemotherapy and palliative radiotherapy in patients with metastatic advanced esophageal squamous cell carcinoma. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Avelumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteTaiwan
Study dates
20 Mar 2019to 31 Dec 2023
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be eligible for inclusion, patients must fulfill the following criteria:
  • Histologically proved squamous cell carcinoma of esophagus
  • Metastatic disease, which are defined by TNM system of American Joint Committee on Cancer (AJCC) Cancer Staging System (8th edition) in 2017, involving distant lymph node (para-aortic or cervical) metastasis and/or visceral metastasis (lung, liver) documented by radiological examinations
  • Age ≥ 20 years
  • ECOG Performance Status 0 or 1
  • Adequate bone marrow reserves within 2 weeks prior to registration, defined as:a. absolute neutrophil count (ANC) ≥ 1.5×109/L (1,500/μl)b. platelets ≥ 100×109/L (100,000/µl)c. hemoglobin ≥ 9.0 g/dl (may have been transfused)
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  • Adequate liver function reserves within 2 weeks prior to registration, defined as:
  • hepatic transaminases (AST and ALT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 × ULN for subjects with documented metastatic disease to liver
  • serum total bilirubin ≤ 2.5 × upper limit of normal (ULN)
  • Adequate renal function within 2 weeks prior to registration: Creatinine ≤1.5 mg/dL
  • Negative serum or urine pregnancy test for women of childbearing potential
  • Women of childbearing potential and male participants must practice highly effective contraception throughout the study and for at least 30 days after last avelumab treatment administration if the risk of conception exists
  • Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent

Who cannot join

  • Patients fulfill any of the following criteria will be excluded from this trial
  • Prior radiotherapy to head and neck, chest, or abdomen
  • Tumor invasion to adjacent structures (T4 lesion)
  • Adenocarcinoma of esophagus or gastroesophageal junction.
  • No measurable metastatic target lesion(s) by RECIST criteria
  • Synchronously or metachronously diagnosed squamous cell carcinoma of aerodigestive way, other than esophageal cancer
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  • Prior invasive malignancy
  • Prior organ transplantation including allogenic stem-cell transplantation
  • Current use of immunosuppressive medication, EXCEPT for the following:
  • intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
  • systemic corticosteroids at physiologic doses '≤ 10 mg/day of prednisone or equivalent
  • steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
  • Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
  • Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:
  • Uncontrolled active infection requiring intravenous antibiotics at the time of registration
  • Transmural myocardial infarction < 6 months prior to registration
  • Unstable angina or congestive heart failure requiring hospitalization < 6 months prior to registration
  • Life-threatening uncontrolled clinically significant cardiac arrhythmias
  • Cerebral vascular accident/stroke (< 6 months prior to enrollment)
  • Congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness including pulmonary fibrosis requiring hospitalization or precluding study therapy at the time of registration
  • Uncontrolled psychiatric disorder including recent (within the past year) or active suicidal ideation or behavior
  • Laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results
  • Immune colitis, inflammatory bowel disease, immune pneumonitis
  • Known history of testing positive for HIV or known acquired immunodeficiency syndrome."
  • Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive)
  • Vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines
  • Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3)"
  • Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Taiwan University Hospital, Taiwan

    Taipei

Other trials in Taiwan

About this study

Official title: Chemotherapy/Avelumab Plus Radiotherapy to Primary Esophageal Tumor for Newly Diagnosed Metastatic Esophageal Squamous Cell Carcinoma: The Ave-CRT Study

This is a single institutional, single arm, open labeled phase II study to assess the overall radiographic response of adding Avelumab to chemotherapy and palliative radiotherapy in patients with metastatic advanced esophageal squamous cell carcinoma.

Read the detailed description

Avelumab belongs to the group of immune checkpoint blockade cancer therapies. Avelumab binds to the programmed death-ligand 1 (PD-L1) and therefore inhibits binding to its receptor programmed cell death 1 (PD-1). In the case of avelumab, the formation of PD-1/PDL1 ligand pairs is blocked and CD8+ T cell immune response should be increased. This study comprises 2 phases, the concurrent immune-chemoradiotherapy (Ave-PF-CRT) phase and the immune-chemotherapy (Ave-PF) phase. In the immune-chemoradiotherapy phase, patients are treated with PF-CRT and concomitant Avelumab. In the immune-chemotherapy phase, patients are treated with PF plus Avelumab. Overall radiological response, time to progression, overall survival and adverse events will be evaluated. Subjects' health-related quality of life will be assessed as well.

Being tested
Avelumab
Medical subject headings
Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AvelumabDrug

    Also called Bavencio

    The study treatment comprises two phases, the concurrent immune-chemoradiotherapy (Ave-PF-CRT) phase and the immune-chemotherapy (Ave-PF) phase. All the subjects will receive Avelumab at both phases.

Study groups in NCT03800953
Study groupRoleWhat they receive
Avelumab (Bavencio)ExperimentalThis is a single arm, and open label study. All the subjects recruited will receive Avelumab.
Receives: Drug: Avelumab

What is being measured

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

  1. overall radiographic response

    overall radiographic response at six-month will be determined by iRECIST

    Measured: 6 months

Secondary outcomes (6)

  1. Best radiographic response

    The best radiographic response of in-field irradiated and out-field non-irradiated (abscopal effect) target lesions will be determined by iRECIST.

    Measured: up to 2 years

  2. Progression-free survival

    Kaplan-Meier survival estimator will be used to determine the median time to progression for study population (along with 95% confidence interval). The log-rank test will be performed to evaluate the equality of survivor functions across stage, and other covariates of interest on progression-free survival.

    Measured: up to 2 years

  3. Overall survival

    Kaplan-Meier survival estimator will be used to determine the median time to death for study population (along with 95% confidence interval). The log-rank test will be performed to evaluate the equality of survivor functions across stage, age, and other covariates of interest on overall survival.

    Measured: up to 2 years

  4. Frequency of adverse events

    The tabulations will count the number of subjects reporting individual adverse events. Adverse events are collected/assessed during treatment period (every week in the Ave-PF-CRT phase [one cycle, 4 weeks], the first and third week of each cycle in the Ave-PF phase [5 cycles, each cycle is 4 weeks]), every 3 months during evaluation, and in 2 years.

    Measured: up to 2 years

  5. Heath-related quality of life

    The self-reported health-related quality of life specific to esophageal cancer is a 44-item functioning scale captured using the Functional Assessment Of Cancer Therapy-Esophageal (FACT-E) Traditional Chinese version. Each question uses a 5-point Likert scale ranging from 0 to 4, and higher scores indicate better quality of life (0-176 for FACT-E total score). The FACT-E is assessed before treating is given, in the third week of Ave-PF-CRT phase (one cycle, 4 weeks), in the first week of every cycle (4 weeks) during the Ave-PF phase (5 cycles), and in the 2 years.

    Changes in total score of FACT-E from baseline to each assessment point will be calculated.

    Measured: up to 2 years

  6. New metastasis-free survival

    Kaplan-Meier survival estimator will be used to determine the median time to development of new metastasis for study population (along with 95% confidence interval). The log-rank test will be performed to evaluate the equality of survivor functions across stage, and other covariates of interest on new metastasis-free survival.

    Measured: up to 2 years

Timeline

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

  1. First posted11 Jan 2019
  2. Study start20 Mar 2019
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2023 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03800953
Sponsor's protocol ID
201809084MIPC
Status last verified
Nov 2020
First submitted
8 Jan 2019
Last updated
8 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avelumab in people with Esophageal Tumor and Metastatic Esophageal Squamous Cell Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.

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 30 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 8 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 Taiwan. 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?

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?

overall radiographic response (time frame: 6 months). 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 NCT03800953.

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 8 Sep 2021.

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