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New treatment option for Late-stage Resectable Esophageal Squamous Carcinoma
Official title Exploratory Clinical Study of Camrelizumab Combined With Concurrent Chemoradiotherapy as an Organ-preserving Strategy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT07622797
What this study is testing
What is Camrelizumab (anti-PD-1 inhibitor)?
Camrelizumab (anti-PD-1 inhibitor) is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for late-stage resectable esophageal squamous carcinoma.
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 is a prospective, exploratory clinical study aimed at evaluating the feasibility and safety of camrelizumab combined with synchronous chemoradiotherapy as an organ-preserving strategy for locally advanced resectable esophageal squamous cell carcinoma. The study targets patients with locally advanced resectable stage II/III/IVa (cT1b-4aN0-3M0) ESCC.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Age ≥18 years old; 2. Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC); 3. Patients with locally advanced...
- Hemoglobin ≥90 g/L; absolute neutrophil count (ANC) ≥1.5 × 10\^9/L; platelets ≥100 × 10\^9/L (patients must not have received blood transfusion or...
- ALT and AST ≤2.5 times the upper limit of normal (ULN); ALP ≤2.5 times ULN;
- Total serum bilirubin \<1.5 times ULN (patients with Gilbert's syndrome may enroll if total bilirubin \<3 times ULN);
- Serum creatinine \<1.5 times ULN or estimated glomerular filtration rate ≥60 ml/min/1.73 m²;
You likely can't join if
- 1\. Individuals allergic to the treatment drugs; 2. History of organ transplantation (including autologous bone marrow transplantation and peripheral...
- 11\. Patients who are using immunosuppressive agents or systemic corticosteroid therapy for immunosuppression purposes (dose \>10 mg/day of...
See the full eligibility criteria
- 1\. Age ≥18 years old; 2. Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC); 3. Patients with locally advanced resectable stage II/III/IVa (cT1b-4aN0-3M0) ESCC; 4. Have not received...
- Hemoglobin ≥90 g/L; absolute neutrophil count (ANC) ≥1.5 × 10\^9/L; platelets ≥100 × 10\^9/L (patients must not have received blood transfusion or growth factor support within 14 days before blood sampling);
- ALT and AST ≤2.5 times the upper limit of normal (ULN); ALP ≤2.5 times ULN;
- Total serum bilirubin \<1.5 times ULN (patients with Gilbert's syndrome may enroll if total bilirubin \<3 times ULN);
- Serum creatinine \<1.5 times ULN or estimated glomerular filtration rate ≥60 ml/min/1.73 m²;
- Serum albumin ≥30 g/L;
- International normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN, unless the patient is on anticoagulant therapy and PT value is within the expected therapeutic range;
- Activated partial thromboplastin time (APTT) ≤1.5 times ULN. 9. Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%). 10\. Women of childbearing potential must agree to...
- 1\. Individuals allergic to the treatment drugs; 2. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation); 3. Active or uncontrolled severe...
- 11\. Patients who are using immunosuppressive agents or systemic corticosteroid therapy for immunosuppression purposes (dose \>10 mg/day of prednisone or other equivalent steroids, and continued use within 2 weeks prior...
The study team makes the final eligibility decision.
Where it's taking place
- Luoyang, Henan, 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 3 weeks 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Luoyang, Henan, 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.