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Tests treatment safety and results for Esophageal Squamous Cell Carcinoma (ESCC)
Official title Phase II Study Evaluating Safety and Efficacy of Tislelizumab for Elderly Patients Unfit for Chemotherapy, With Advanced Esophageal Squamous-cell Carcinoma
ClinicalTrials.gov ID: NCT07205731
What this study is testing
What is Tislelizumab is a fully humanized monoclonal antibody specific for human PD-1?
Tislelizumab is a fully humanized monoclonal antibody specific for human PD-1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for esophageal squamous cell carcinoma (escc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to assess the percentage of patients alive at 6 months in elderly patients, not eligible to an platinum-based chemotherapy, but who can received the Tislelizumab treatment alone as first-line treatment for an advanced esophageal squamous-cell carcinoma (ESCC). Tislelizumab is a monoclonal antibody administred by intravenous infusion This study aims to anwer too at the questions: the Safety of the drug Overall survival (OS) at 6 months according the diagnostic of PD-L1 expression (PD-L1 is a protein present on the surface of immune cells) Overall response rate (ORR) according to imagery criteria Progression-free survival (PFS) at 3 and 6 months according to imagery criteria and depending on PDL1 expression Patients' health-related quality of life OS and PFS according to geriatric parameters Prognostic value of immune biomarkers
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 70 and older
You may be able to join if
- Histologically proven esophageal squamous cell carcinoma (ESCC)
- Metastatic or locally advanced cancer
- Absence of previous treatment (immunotherapy, chemotherapy or radiotherapy) in first line setting
- Ineligibility for a platinum-based chemotherapy assessed by oncologist and geriatrician
- At least one evaluable and/or measurable lesion as defined by RECIST v1.1 criteria
You likely can't join if
- History of another primary malignancy. May be included, patients with:
- Malignancy treated with curative intent and with no known active disease ≥ 2 years before the first dose of treatment
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- Locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy per local investigator
- Participation in another clinical study with an investigational product during the last 2 months.
See the full eligibility criteria
- Histologically proven esophageal squamous cell carcinoma (ESCC)
- Metastatic or locally advanced cancer
- Absence of previous treatment (immunotherapy, chemotherapy or radiotherapy) in first line setting
- Ineligibility for a platinum-based chemotherapy assessed by oncologist and geriatrician
- At least one evaluable and/or measurable lesion as defined by RECIST v1.1 criteria
- Patients ≥ 70 years
- people with WHO performance status ≤ 2
- Estimated life expectancy \>3 months
- Adjuvant therapy finished \>6 months
- Adequate marrow and organ functions defined as:
- Absolute neutrophil count (ANC) ≥ 1 × 109/L,
- Platelet count ≥ 75 × 109/L,
- Hemoglobin ≥ 90 g/L,
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 × ULN, or AST and ALT ≤5 ×ULN for patients with liver metastases
- ALP ≤ 5 x ULN unless liver metastases are present, in which case it must be ≤ 10x ULN
- Measured creatinine clearance (CL) \> 40 mL/min (MDRD method)
- Male patients must use a condom during treatment and for 6 months after the last dose when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients...
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits and examinations including follow up.
- Signed written informed consent obtained prior to any study specific procedures
- Patient affiliated to a social security scheme
- History of another primary malignancy. May be included, patients with:
- Malignancy treated with curative intent and with no known active disease ≥ 2 years before the first dose of treatment
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- Locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy per local investigator
- Participation in another clinical study with an investigational product during the last 2 months.
- Concurrent enrolment in another clinical study unless it is an observational (non-treatment) clinical study or during the follow-up period of an treatment study.
- History of allogenic organ, bone marrow, or double umbilical cord blood transplantation
- Active documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis...
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.
- Any chronic skin condition that does not require systemic therapy.
- Patients with celiac disease controlled by diet alone
- Previous immune checkpoint inhibitor therapy within the 2 years before inclusion
- Uncontrolled intercurrent illness; uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention (recurrence ≤ 14 days after intervention). Patients with the...
- Controlled Type I diabetes
- Hypothyroidism (provided it is managed with hormone replacement therapy only)
- Controlled celiac disease
- Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, alopecia)
- Any other disease that is not expected to recur in the absence of external triggering factors
- Patients with evidence of fistula (either oesophageal/bronchial or oesophageal/aorta)
- Patients considered at poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active, uncontrolled ventricular arrhythmia, recent (within 6 months) myocardial infarction...
- Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
- Patient with symptomatic central nervous system (CNS) metastases.
- History of active primary immunodeficiency.
- Known non-controlled serologically positive human immunodeficiency virus (HIV) patients with CD4 \< 400 / mm3.
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), active untreated hepatitis B...
- Current or prior use of immunosuppressive medication within 14 days before the first dose of -immunotherapy. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- Receipt of live attenuated vaccine within 30 days prior to the first dose of ICI
- Follow-up impossible, according to investigator's decision
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol or follow-up schedule
- Persons i) deprived of liberty by judicial or administrative decision, persons subject to psychiatric care under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8 and persons...
The study team makes the final eligibility decision.
Where it's taking place
- Annecy, Epagny Metz-Tessy, France
- Amiens, France
- Avignon, France
- Bayonne, France
- Besançon, France
- Beuvry, France
- Brest, France
- Caen, France
- Clermont-Ferrand, France
- Dijon, France
- Grenoble, France
- Lille, France
- Limoges, France
- Lyon, France
- Nancy, France
- Paris, France
- Perpignan, France
- Poitiers, France
- Reims, France
- Rennes, France
+ 6 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 70 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Annecy, Epagny Metz-Tessy, France; Amiens, France; Avignon, France; Bayonne, France; Besançon, France; Beuvry, France and 20 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.