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Esophageal CancerPhase 2CRATERNCT05245760

ChemoRadiation And Tislelizumab for Esophageal/EGJ Cancer

A Phase 2 study testing Intravenous Tislelizumab, Chemotherapy and Fractionated radiation in people with Esophageal Cancer and Esophagogastric Junction Cancer, run by Zhonglin Hao at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study aims to determine the effects of chemoradiation and Tislelizumab on Esophageal/EGJ Cancer before and after surgery. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Intravenous Tislelizumab, Chemotherapy and Fractionated radiation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Apr 2022to Dec 2033
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
  • Age ≥ 18 years but 80 years or younger on the day of signing the informed consent form.
  • Histologically proven esophageal squamous cell cancer or adenocarcinoma.
  • De novo diagnosis, have not received prior treatment
  • AJCC 8. T1N1 or T2-4aN0-2M0 resectable disease
  • ECOG Performance Status ≤ 1
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  • Adequate organ function as indicated by the following laboratory values
  • Patients must not have required a blood transfusion or growth factor support ≤ 14 days before sample collection at screening for the following i. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L ii. Platelets ≥ 100 x 109/L iii. Hemoglobin ≥ 90 g/L b. Serum creatinine ≤ 1.5 x ULN (upper limit of normal) or estimated Glomerular Filtration Rate ≥ 60 mL/min/1.73 m2 c. Serum total bilirubin ≤ 1.5 x ULN (total bilirubin must be < 3 x ULN for patients with Gilberts syndrome). d. AST and ALT ≤ 3 x ULN
  • Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 120 days after the last dose of tislelizumab, and have a negative urine or serum pregnancy test ≤ 7 days before the first dose of tislelizumab.
  • Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab

Who cannot join

  • Unresectable disease either T4b or M1 per AJCC8
  • Deemed inoperable for any reason by attending surgeon
  • Any prior treatment directed at the tumor except biopsy.
  • Active autoimmune diseases such as SLE, RA requiring systemic immunosuppression or history of autoimmune diseases that may relapse.
  • Any active malignancy ≤ 2 years before first dose of study drug, except for cancer that has been treated curatively (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
  • Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before tislelizumab. Note: Patients who are currently or have previously been on any of the following steroid regimens are not excluded:
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  • Adrenal replacement steroid (dose ≤ 15 mg daily of prednisone or equivalent)
  • Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption
  • Short course (≤ 7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non-autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen)
  • Laboratory test abnormalities in potassium, sodium, or corrected calcium > Grade 1 despite standard medical management
  • History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
  • Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc.
  • A known history of HIV infection not controlled with anti-retroviral therapy
  • Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is > 500 IU/mL or patients with active hepatitis C virus (HCV) should be excluded. Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA < 500 IU/mL), and cured hepatitis C patients can be enrolled
  • Prior allogeneic stem cell transplantation or organ transplantation
  • Any of the following cardiovascular risk factors:
  • Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before first dose of tislelizumab and chemotherapy
  • Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV (Appendix 6) ≤ 6 months
  • Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months prior to initiation of treatment on study.
  • A history of severe hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Has received radiation therapy within 4 weeks, chemotherapy, immunotherapy (e.g., interleukin, interferon, thymosin), or any investigational therapies within 14 days or 5 half lives (whichever is shorter) of the first study drug administration
  • Was administered a live vaccine ≤ 4 weeks before tislelizumab Note: Seasonal vaccines for influenza are generally inactivated vaccines and are allowed.
  • Intranasal vaccines are live vaccines and are not allowed. The mRNA vaccine for SARSCoV2 is allowed if the second dose is administered two weeks before study drug is administered.
  • Underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse or dependence that, will be unfavorable for the administration of study drug or affect the explanation of drug toxicity or AEs or result in insufficient or might impair compliance with study conduct.
  • Concurrent participation in another therapeutic clinical study.
  • History of allergy to platinum or taxane
  • Li-Fraumeni Syndrome where radiation is contraindicated

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Kentucky

    Lexington, Kentucky, 40536

Other trials in United States

About this study

This study aims to determine the effects of chemoradiation and Tislelizumab on Esophageal/EGJ Cancer before and after surgery.

Read the detailed description

Esophageal cancer patients in this trial will receive chemoradiation therapy with tislelizumab, which is an anti-PD-1 antibody, before surgery. Patient will be evaluated for complete pathological response or major pathological response rate following chemoradiation. Patient will continue on to get tislelizumab after surgery to complete total of a year of treatment. They will be evaluated for PFS and OS. Throughout the study, drug tolerability and toxicities will be monitored.

Being tested
Intravenous Tislelizumab, Chemotherapy, Fractionated radiation, Esophagectomy
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • Intravenous TislelizumabDrug

    Also called immunotherapy

    Participants will receive 200mg, every three weeks for up to 51 weeks

  • ChemotherapyDrug

    Also called carboplatin and paclitaxel

    Carboplatin (AUC2) and Paclitaxel (50mg/m2), Weekly x 5 weeks

  • Fractionated radiationRadiation

    Concurrent with chemo, x5 weeks

  • EsophagectomyProcedure or surgery

    Surgical resection of cancer after chemoradiation therapy when no disease progression found.

Study groups in NCT05245760
Study groupRoleWhat they receive
All patientExperimentalAll patients receive Tislelizumab, q3week; chemotherapy with carboplatin and paclitaxel weekly concurrently for 5 weeks before surgery. Tislelizumab is continued q3week in all patients after surgery for a total of one year from the start of study.
Receives: Drug: Intravenous Tislelizumab; Drug: Chemotherapy; Radiation: Fractionated radiation; Procedure: Esophagectomy

What is being measured

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

  1. Pathological complete response rate (pCR)

    Pathological complete response (pCR) rate in patients treated with tislelizumab and chemoradiation followed by surgery. The pCR rate will be estimated by number of patients who has had pCR divided by the total number of evaluable patients treated with neoadjuvant therapy before surgery. The exact 95% confidence interval of the pCR rate will be provided.

    Measured: 12 months

Secondary outcomes (2)

  1. Progression free survival (PFS)

    The time from the participants' date of surgery to the date of disease progression or death, whichever occurs first

    Measured: 12 months

  2. Major pathological response (MPR)

    The number of patients who had 90% or more tumor showing necrosis divided by the total number of evaluable patients treated with neoadjuvant therapy before surgery

    Measured: 12 months

Timeline

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

  1. First posted18 Feb 2022
  2. Study startApr 2022 (estimated)
  3. Primary completionMar 2023 (estimated)
  4. Study completionDec 2033 (estimated)

Why it stopped: Funding unavailable.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05245760
Sponsor's protocol ID
MCC-21-LUN-125-PMC
Acronym
CRATER
Status last verified
Nov 2022
First submitted
8 Feb 2022
Last updated
8 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intravenous Tislelizumab, Chemotherapy and Fractionated radiation in people with Esophageal Cancer and Esophagogastric Junction Cancer, run by Zhonglin Hao at 1 site in United States.

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 10 inclusion and 27 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: withdrawn, as of the sponsor's last update on 8 Nov 2022. 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 United States. 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 withdrawn before enrolling participants, so there are no results.

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?

Pathological complete response rate (pCR) (time frame: 12 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 NCT05245760.

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 Nov 2022.

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CRATER Clinical Trial NCT05245760 | AzTrials