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New treatment option for Esophageal Squamous Cell Carcinoma (ESCC)
Official title A Phase II Clinical Study of Sintilimab Combined with Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC) (NICE-CS)
ClinicalTrials.gov ID: NCT06709417
What this study is testing
What is Sintilimab?
Sintilimab 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
- This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of sintilimab combined with chemotherapy, followed by sequential concurrent chemoradiotherapy as conversion therapy, in treatment-naïve esophageal squamous cell carcinoma (ESCC) patients with cT4bN-/+M0 and/or cTanyN+M0 staging (including those with extracapsular invasion of mediastinal lymph nodes).
- 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 20 to 75
You may be able to join if
- Signed written informed consent prior to the initiation of any study-related procedures.
- Age: ≥20 years and ≤75 years, no gender restrictions.
- Diagnosed with esophageal squamous cell carcinoma (ESCC) based on histopathology and imaging, with clinical staging of cT4bN-/+M0 and/or cTanyN+M0...
- Thoracic segment esophageal squamous cell carcinoma.
- Primary lesion is inoperable or inoperable due to extracapsular invasion of mediastinal lymph nodes.
You likely can't join if
- Diagnosis of malignancies other than esophageal cancer within 5 years prior to the first dose of the investigational drug (excluding radically...
- Patients with existing or high-risk tracheoesophageal or aortoesophageal fistulas.
- Presence of distant metastases.
- Current participation in an treatment clinical study or receipt of other investigational drugs or devices within 4 weeks prior to the first dose.
- Prior treatment with anti-PD-1, anti-PD-L1, or any other agents targeting stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137).
- Receipt of systemic antitumor traditional Chinese medicine or immunomodulatory drugs (including thymosin, interferon, or interleukin) within 2 weeks...
See the full eligibility criteria
- Signed written informed consent prior to the initiation of any study-related procedures.
- Age: ≥20 years and ≤75 years, no gender restrictions.
- Diagnosed with esophageal squamous cell carcinoma (ESCC) based on histopathology and imaging, with clinical staging of cT4bN-/+M0 and/or cTanyN+M0 (extracapsular invasion of mediastinal lymph nodes).
- Thoracic segment esophageal squamous cell carcinoma.
- Primary lesion is inoperable or inoperable due to extracapsular invasion of mediastinal lymph nodes.
- ECOG performance status (PS) of 0-1.
- Estimated survival time ≥6 months.
- No prior antitumor therapy for esophageal cancer, including but not limited to chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
- At least one measurable lesion as per RECIST 1.1 criteria.
- No surgical contraindications based on preoperative evaluation of organ function.
- Adequate organ function
- Female participants of childbearing potential must have a negative urine or serum pregnancy test within three days prior to receiving the first dose of study medication (Cycle 1, Day 1). If the urine pregnancy test...
- Diagnosis of malignancies other than esophageal cancer within 5 years prior to the first dose of the investigational drug (excluding radically treated basal cell carcinoma of the skin, carcinoma in situ of the cervix...
- Patients with existing or high-risk tracheoesophageal or aortoesophageal fistulas.
- Presence of distant metastases.
- Current participation in an treatment clinical study or receipt of other investigational drugs or devices within 4 weeks prior to the first dose.
- Prior treatment with anti-PD-1, anti-PD-L1, or any other agents targeting stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137).
- Receipt of systemic antitumor traditional Chinese medicine or immunomodulatory drugs (including thymosin, interferon, or interleukin) within 2 weeks prior to the first dose, except for local use to control pleural...
- Active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs) within 2 years prior to the first dose, excluding replacement therapy (e.g., thyroid...
- Use of systemic corticosteroids (excluding nasal, inhaled, or other locally administered corticosteroids) or other immunosuppressive drugs within 7 days prior to the first dose, except for physiological doses of...
- History of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- Known hypersensitivity to active ingredients or excipients in the investigational product.
- Failure to recover adequately (≤Grade 1 or baseline) from prior therapy-induced toxicities and/or complications prior to initiating treatment (excluding fatigue or alopecia).
- Known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive).
- Untreated active hepatitis B, defined as HBsAg positivity with HBV DNA levels exceeding the upper limit of normal (ULN) at the study center. people meeting the following criteria are eligible: HBV DNA \<1000 copies/mL...
- Active hepatitis C infection, defined as HCV antibody positivity and HCV RNA levels above the lower limit of detection.
- Receipt of live vaccines within 30 days prior to the first dose (Cycle 1, Day 1), except for injectable inactivated influenza vaccines administered within 30 days prior to the first dose. Intranasal attenuated live...
- Pregnant or breastfeeding women.
- History of gastrointestinal bleeding within 6 months prior to treatment or concurrent coagulation disorders, or patients on thrombolytic or anticoagulant therapy with a high risk of bleeding.
- Any severe or uncontrolled systemic disease, including but not limited to:
- Major, symptomatic, and poorly controlled abnormalities in cardiac rhythm, conduction, or morphology on resting ECG, such as complete left bundle branch block, second-degree or higher heart block, ventricular...
- Unstable angina or congestive heart failure classified as NYHA grade ≥2.
- Arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment, including myocardial infarction, unstable angina, cerebrovascular accidents, or transient ischemic attacks.
- Poorly controlled blood pressure (systolic BP \>140 mmHg, diastolic BP \>90 mmHg).
- History of non-infectious pneumonitis requiring corticosteroid therapy within 1 year prior to the first dose or current clinically active interstitial lung disease.
- Active pulmonary tuberculosis.
- Active or uncontrolled infections requiring systemic therapy.
- Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
- Liver diseases, such as cirrhosis, decompensated liver disease, or acute/chronic active hepatitis.
- Poorly controlled diabetes mellitus (fasting blood glucose \>10 mmol/L).
- Proteinuria ≥++ on urinalysis, confirmed by 24-hour urinary protein quantification \>1.0 g.
- Psychiatric disorders that interfere with compliance or treatment.
- Any history, evidence of disease, abnormal treatment, or laboratory findings that could interfere with study outcomes, impede full participation, or, in the investigator's opinion, render the subject unsuitable for the...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Compensation & support
A stipend or compensation may be offered.
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, 20 years to 75 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.