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New treatment option for Esophageal Squamous Cell Carcinoma
Official title Optimization of Treatment Strategy for Unresectable cN3 Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06122493
What this study is testing
What is Tirelizumab?
Tirelizumab is an investigational medicine, being studied as a potential treatment for esophageal squamous cell carcinoma.
Also referred to as anti-PD-1 monoclonal antibody.
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
- This study aims to investigate a comprehensive therapeutic approach for patients with unresectable esophageal squamous cell carcinoma, clinically staged as Tany, N3, M0, and who are not candidate for concurrent chemoradiotherapy combined with immunotherapy. The approach entails combining chemotherapy with immune therapy, followed by synchronized radiotherapy during the immune maintenance phase.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Esophageal squamous cell carcinoma confirmed through histopathology.
- Distant metastasis excluded by CT, MRI, or PET/CT examinations.
- Locally advanced stage: AJCC/UICC eighth edition staging with any T, N3M0.
- Expected survival time of at least 6 months.
- With an ECOG performance status of 0 to 2. Not accompanied by severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease...
You likely can't join if
- Existing or prior history of other malignant tumors (except non-melanoma skin cancer) that are uncontrolled or not cured, depending on the type of...
- Lack of histological or cytological diagnosis for esophageal cancer.
- Previous chest radiotherapy.
- Suffering from innate or acquired immune function defects;
- Pregnancy (confirmed by serum or urine β-HCG test) or during the lactation period; History of drug abuse or alcohol dependence; HIV-positive status...
- Poor overall health status, defined as KPS \ 2.
See the full eligibility criteria
- Esophageal squamous cell carcinoma confirmed through histopathology.
- Distant metastasis excluded by CT, MRI, or PET/CT examinations.
- Locally advanced stage: AJCC/UICC eighth edition staging with any T, N3M0.
- Expected survival time of at least 6 months.
- With an ECOG performance status of 0 to 2. Not accompanied by severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, severe chronic heart disease, or other comorbidities that could impact...
- Adequate function of major organs: Hematopoietic function: Hemoglobin ≥100g/L, platelets ≥90×109/L, white blood cells ≥4×109/L. Exceptions may be considered for patients with ECOG 0-1 who have a history of chronic...
- Patients are required to provide informed consent to undergo treatment.
- Existing or prior history of other malignant tumors (except non-melanoma skin cancer) that are uncontrolled or not cured, depending on the type of the primary tumor.
- Lack of histological or cytological diagnosis for esophageal cancer.
- Previous chest radiotherapy.
- Suffering from innate or acquired immune function defects;
- Pregnancy (confirmed by serum or urine β-HCG test) or during the lactation period; History of drug abuse or alcohol dependence; HIV-positive status, including those on antiretroviral treatment; Chronic hepatitis B with...
- Poor overall health status, defined as KPS \ 2.
- Presence of severe comorbidities that could impact radiotherapy progress, including: Unstable angina, congestive heart failure, or myocardial infarction requiring hospitalization within the past 6 months; Acute...
- Inability to comprehend the treatment's purpose or unwillingness to sign the treatment consent form.
- Lack of legal capacity or limited legal capacity.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.