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Esophageal CancerPhase 2NCT07330583

Stereotactic Body Radiation Therapy (SBRT) and Immunotherapy for Oligometastatic Esophageal Cancer

A Phase 2 study testing Stereotactic body radiation treatment (SBRT) in people with Esophageal Cancer, run by AHS Cancer Control Alberta.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Participants in this study will have esophageal cancer that has spread (metastasized) to other parts of the body either at initial diagnosis (synchronous) or after the cancer returned following treatment (recurrent). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Cancer
What is being tested?
Stereotactic body radiation treatment (SBRT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
No sites listed yet
Study dates
Mar 2027to Mar 2033
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18
  • Eastern Cooperative Oncology Group performance status ≤ 2.
  • Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus.
  • Diagnosed with stage IVB disease (according to UICC TNM version 8) with up to five metastatic lesions in up to three organs.
  • At least one metastatic lesion amenable to the delivery of SBRT.
  • Estimated life expectancy >6 months.
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  • The function of important organs meet the following requirements: a. white blood cell count (WBC) ≥ 4.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L; b. platelets ≥ 100×109/L; c. hemoglobin ≥ 9g/dL; d. serum albumin ≥ 2.8g/dL; e. total bilirubin ≤ 1.5×ULN, ALT, AST and/or AKP ≤ 2.5×ULN; f. serum creatinine ≤ 1.5×ULN or creatinine clearance rate >60 mL/min;
  • Ability to understand the study and sign informed consent.
  • Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level > 40 mIU/mL to confirm menopause.
  • Patients of childbearing/reproductive potential should use highly effective birth control methods if indicated, as defined by the investigator, up to the period of finishing capecitabine and for 6 months after last dose. A highly effective method of birth control is defined as those that result in low failure rate (i.e., less than 1% per year) when used consistently and correctly. Note: abstinence is acceptable if this is established and preferred contraception for the patient.
  • Females must not be breastfeeding while taking capecitabine or within 2 weeks after the last dose.
  • Male patients should agree to not donate sperm during the study while taking capecitabine and for 3 months after the last dose.
  • Male patients should not father a child while taking capecitabine and for 3 months after the last dose.

Who cannot join

  • Progression was confirmed after completion of 4 to 6 cycles of standard chemotherapy and anti-PD1 treatment and not amenable to SBRT.
  • Known or suspected allergy or hypersensitivity to monoclonal antibodies and the chemotherapeutic drugs: Capecitabine, paclitaxel, or platinum.
  • Patients have spinal bone metastases combined with spinal cord compression.
  • A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.
  • Patients who cannot tolerate radiotherapy due to severe cardiac, lung, liver, or kidney dysfunction, or hematopoietic disease or cachexia.
  • Inability to provide informed consent due to psychological, familial, social, and other factors.
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  • Female patients who are pregnant or during lactation.
  • Active autoimmune diseases, or a history of autoimmune diseases (including but not limited to these diseases or syndromes, such as colitis, hepatitis, hyperthyroidism) that precludes the use of immunotherapy as decided by the treating medical oncologist, a history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation.
  • A history of interstitial lung disease or non-infectious pneumonia; Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Aswin Abraham contact

7804328550

Aswin.Abraham@albertahealthservices.ca

About this study

Official title: Phase II Single Arm Study to Evaluate Stereotactic Body Radiation Therapy (SBRT) and Immunotherapy for Management of Patients With Oligometastatic Esophageal Cancer

Participants in this study will have esophageal cancer that has spread (metastasized) to other parts of the body either at initial diagnosis (synchronous) or after the cancer returned following treatment (recurrent).

In Alberta, the current standard approach for treating esophageal cancer that has metastasized is to first give patients radiation to the main tumor in the esophagus to relieve symptoms. After that, they receive a combination of chemotherapy drugs (either CAPOX or FOLFOX) chosen by their doctor, along with immunotherapy drugs like Pembrolizumab or Nivolumab to fight the cancer.

Read more

The study intends to add a treatment called stereotactic body radiation treatment (SBRT), which uses very high doses of radiation in a few sessions, to target small tumors which remain after the standard treatment.

The goal of this study is to see if adding SBRT to chemotherapy and immunotherapy helps patients with newly diagnosed or recurrent esophageal cancer that has metastasized to a few other places. The study aims to improve survival and control the disease better.

Being tested
Stereotactic body radiation treatment (SBRT)
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • Stereotactic body radiation treatment (SBRT)Radiation

    Standard of care 6-9 cycles of chemotherapy and immunotherapy, which will then be followed by stereotactic body radiation treatment to the residual oligometastatic lesion/s.

Study groups in NCT07330583
Study groupRoleWhat they receive
SBRTExperimentalNot described
Receives: Radiation: Stereotactic body radiation treatment (SBRT)

What is being measured

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

  1. Progression free survival

    Defined as time from enrollment into study to disease progression at any site or death.

    Measured: From the date of enrollment in the study for up to approximately 2 years and 7 months or death.

Secondary outcomes (5)

  1. Local recurrence free survival

    Defined as time from enrollment into study to disease progression at site of SBRT treatment or death.

    Measured: From the date of enrollment in the study for up to approximately 2 years and 7 months or death.

  2. Overall Survival (OS)

    Defined as the time from enrollment into study to death due to any cause.

    Measured: From the date of enrollment until the time of death due to any cause, assessed up to approximately 2 years and 7 months

  3. Quality of Life (QOL)

    To study the Quality of Life as measured by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (v3)

    Measured: Screening, 1 - 5 days before the start of each chemotherapy cycle (each cycle is 21 days), 14 - 28 days after completion of chemotherapy (chemotherapy is completed in about 4 months), and 3 monthly after SBRT until 2 years post SBRT

  4. Cancer Specific Survival (CSS)

    Defined as the time from time of enrollment into study to death due to the esophageal cancer.

    Measured: From enrollment until the time of death due to esophageal cancer, assessed up to about 2 years and 7 months.

  5. Toxicity Assessment

    Treatment related toxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5

    Measured: 10 - 20 days after screening (if given), 1 - 5 days prior each cycle of chemotherapy (each cycle is 21 days), 14 - 28 days after end of chemotherapy which is about 4 months, 14-28 days after chemotherapy and 3 monthly after SBRT until 2 years post SBRT.

Timeline

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

  1. First posted9 Jan 2026
  2. Study startMar 2027 (estimated)
  3. Primary completionOct 2029 (estimated)
  4. Study completionMar 2033 (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
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07330583
Sponsor's protocol ID
IIT-0036
Status last verified
Oct 2026
First submitted
29 Aug 2025
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stereotactic body radiation treatment (SBRT) in people with Esophageal Cancer, run by AHS Cancer Control Alberta.

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 9 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: opening soon, as of the sponsor's last update on 28 Oct 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aswin Abraham (7804328550, Aswin.Abraham@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: From the date of enrollment in the study for up to approximately 2 years and 7 months or death.). 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 NCT07330583.

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 28 Oct 2026.

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