AzTrials
AzTrials

Esophageal CancerPhase 2NCT05628610

Tislelizumab Combined With Chemotherapy or Radiotherapy in the Treatment of Advanced or Recurrent Metastatic Elderly Esophageal Cancer

A Phase 2 study testing Tislelizumab, Radiation and Paclitaxel in people with Esophageal Cancer, run by Fujian Cancer Hospital.

Not yet recruiting

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

Official record
Search all trials

Trial summary

To compare the objective response rate (ORR) and safety of tislelizumab combined with chemotherapy and Tislelizumab combined with radiotherapy in elderly patients with esophageal cancer with advanced or recurrent metastasis Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Esophageal Cancer
What is being tested?
Tislelizumab, Radiation and Paclitaxel
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
No sites listed yet
Study dates
30 Sep 2024to 30 Sep 2027
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Signed a written informed consent and volunteered to join the study;
  • Patients with esophageal squamous cell carcinoma confirmed by pathological histological and / or immunohistochemical examination or progressing after surgical resection, (the 8th edition, 2017) with UICC / AJCC TNM stage cT4N0-2M0, c any TN3M0, or c any T any NM1 (clinical stage IV);
  • Unresectable advanced, recurrent, or metastatic oesophageal SCC;
  • Age: 70 years old;
  • E CO G P S 0-2
  • Has not received any systemic antitumor treatment for esophageal cancer, including radiotherapy, chemotherapy, targeted, immunotherapy, etc.;
Show all 10Show fewer
  • At least one measurable lesion was present
  • Main organs have normal function, including:
  • Routine blood tests (no blood components, cell growth factors, whitening agents, platelets, anemia drugs are allowed within 14 days before the first use of the study drug) Leukocyte count was at 3.0109/L Neutrophil count was at 1.0109/L Platelet count was at 8,0109/L Hemoglobin was at 80 g / L b) Blood biochemical examination: Total bilirubin was at 1.5 ULN ALT ≤ 2.5×ULN ，AST ≤2.5×ULN ， Serum creatinine of 1.5 ULN, or creatinine clearance of 45 mL/min (Cocheroft-Gault formula, see Annex 2)
  • -The subjects had good compliance and cooperated with the follow-up

Who cannot join

  • There is uncontrollable pleural effusion, pericardial effusion or ascites that requires repeated drainage;
  • Poor nutritional status, BMI <18.5 Kg / m2; if corrected after symptomatic nutritional support, further enrollment can be considered after evaluation by the principal investigator;
  • Gastrointestinal bleeding (bleeding volume> 200ml / day);
  • Patients adjudged by the researchers to have deep ulcers;
  • Previous history of allergy to monoclonal antibodies, any component of tirellizumab, paclitaxel, cisplatin, or other platinum drugs;
  • Has received or are receiving any of the following treatments:
Show all 15Show fewer
  • Any radiotherapy, chemotherapy, or other antitumor drugs directed against the tumor; Study drug b) Treatment with immunosuppressive drugs or systemic hormones for immunosuppression purposes within 2 weeks of the first study drug (dose or equivalent dose> 10mg / day); inhaled or topical steroids and doses> 10mg / day prednisone or equivalent dose of adrenal corticoid replacement in the absence of active autoimmune disease; The c) Acceptance of a live attenuated vaccine within 4 weeks before the first use of the study drug; d) Major surgery or severe trauma within 4 weeks prior to the first use of the study drug;
  • History of any active autoimmune or autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (considered after HRT); patients with psoriasis or asthma / allergy in childhood remission and adults without any intervention, but patients requiring bronchodilator are not included;
  • A history of immunodeficiency, including positive HIV testing, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;
  • Poor clinical cardiac symptoms or disease, including but not limited to:
  • Such as (1) heart failure of grade NYHAII or above; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) clinical significance of supraventricular or ventricular arrhythmia without clinical intervention or clinical intervention is not well controlled;
  • Severe infection (CTCAE> 2) within 4 weeks before initial use of study drug, such as severe pneumonia, bacteremia, or infection complications requiring hospitalization; baseline chest imaging indicates active lung inflammation, symptoms or signs of infection within 14 days prior to initial use of study drug, or requiring oral or intravenous antibiotics, except for prophylactic antibiotics;
  • Patients with active tuberculosis infection by medical history or CT examination, or active tuberculosis infection within 1 year prior to enrollment, or active tuberculosis infection within 1 year before enrollment, or before enrollment but without formal treatment;
  • The presence of active hepatitis B (HBV DNA 2000 IU / mL or 104 copies / mL), hepatitis C (hepatitis C antibody positive, and HCV RNA above the lower limit of the analysis method);
  • According to the investigator, there are other factors present that may lead to the forced termination of the study, such as other serious illness (including mental illness) requiring combined treatment, alcohol abuse, substance abuse, family or social factors, that may affect the safety or compliance of the subject.

About this study

To compare the objective response rate (ORR) and safety of tislelizumab combined with chemotherapy and Tislelizumab combined with radiotherapy in elderly patients with esophageal cancer with advanced or recurrent metastasis

Being tested
Tislelizumab, Radiation, Paclitaxel, Platinum: cisplatin, carboplatin, naidaplatin and other platinum drugs
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • TislelizumabDrug

    200mg d1, Q3W

  • RadiationRadiation

    Radiotherapy dose: 5,000 c G y / 30f

  • PaclitaxelDrug

    Paclitaxel: 150mg / m2 ,d1, q3w

  • Platinum: cisplatin, carboplatin, naidaplatin and other platinum drugsDrug

    cisplatin, carboplatin, naidaplatin and other platinum drugs

Study groups in NCT05628610
Study groupRoleWhat they receive
Tislelizumab combined with radiotherapyExperimentalNot described
Receives: Drug: Tislelizumab; Radiation: Radiation
Tislelizumab combined with chemotherapyExperimentalNot described
Receives: Drug: Tislelizumab; Drug: Paclitaxel; Drug: Platinum: cisplatin, carboplatin, naidaplatin and other platinum drugs

What is being measured

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

  1. objective response rate

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

    Measured: 12 months

Secondary outcomes (1)

  1. progression free survival

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

    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 posted28 Nov 2022
  2. Study start30 Sep 2024 (estimated)
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2027 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05628610
Sponsor's protocol ID
Tisle-001
Status last verified
Aug 2024
First submitted
18 Nov 2022
Last updated
13 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab, Radiation and Paclitaxel in people with Esophageal Cancer, run by Fujian Cancer Hospital.

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 15 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 13 Aug 2024. 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?

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?

objective response rate (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 NCT05628610.

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 13 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in