Locally advanced unresectable or advanced metastatic esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group:After 6 weeks of combined synchronous chemo-radiotherapy with QL1706, QL1706 maintenance treatment continues until disease progression, intolerable toxicity, or up to 2 years.
Sponsors
Yancheng First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age 18 or older; gender not restricted; 2.Stage III–IV locally advanced unresectable or advanced metastatic esophageal squamous cell carcinoma, as confirmed by histopathology or cytology; 3.Has not received systematic anticancer treatment; 4.ECOG PS 0–2; 5.Adequate organ and bone marrow function, defined as follows: hemoglobin >= 9.0 g/dL, absolute neutrophil count >= 1.5 × 10^9/L, platelet count >= 100 × 10^9/L, INR = 3.0 g/dL Serum creatinine 60 mL/min or creatinine clearance calculated using the Cockcroft-Gault formula (using actual body weight) > 60 mL/min: Male: Creatinine clearance = (Weight × (140 – Age)) / (72 × Serum Creatinine) Female: Creatinine clearance = (Weight × (140 – Age)) / (72 × Serum Creatinine) × 0.85 Where CL = mL/min; Serum Creatinine = mg/dL; 6.Patients with active HBV infection should receive antiviral therapy for at least 2 weeks prior to enrollment in accordance with local antiviral treatment guidelines, and should continue this therapy for 6 months following treatment with the study drug; 7.A negative result for hepatitis C virus (HCV) antibodies at the time of screening, or a positive result for HCV antibodies at the time of screening followed by a negative result for HCV RNA; 8.Expected survival of >=12 weeks; 9.The patient signed the informed consent form and voluntarily enrolled in this study.
Exclusion criteria
Exclusion criteria: 1.At high risk for esophageal fistula, such as a history of esophageal fistula or related symptoms, or primary tumor invasion into major blood vessels or the trachea; 2.Evidence of complete esophageal obstruction; not suitable for treatment; 3. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease [such as colitis or Crohn's disease], diverticulitis [excluding diverticular disease], systemic lupus erythematosus, sarcoidosis, or Wegener's syndrome [granulomatosis with polyangiitis], Graves' disease, rheumatoid arthritis, hypophysitis, and uveitis). Exceptions to this rule include: (1) Patients with vitiligo or hair loss; (2) Patients with hypothyroidism (e.g., post-Hashimoto's) who are on stable hormone replacement therapy; (3) Any chronic skin disease that does not require systemic treatment; (4) Patients with no active disease within the past 5 years, but only after consultation with the study doctor; (5) Patients with celiac disease controlled solely by diet. 4. Active infections, including tuberculosis (clinically evaluated based on medical history, physical examination, imaging results, and tuberculosis tests in line with local treatment guidelines); 5. Uncontrolled complications, including but not limited to ongoing or active infections, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, uncontrolled cardiac arrhythmias, active interstitial lung disease, severe chronic gastrointestinal diseases with diarrhea, or mental/social conditions that limit adherence to study requirements, significantly increase the risk of AEs, or impair the patient’s ability to give written informed consent; 6. Previous thyroid dysfunction that cannot be maintained within normal range even under medication; 7. Use of immunosuppressive drugs within 14 days prior to the first QL1706 dose, or in the past. Exceptions include: (1) Nasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injections); (2) Systemic glucocorticoids not exceeding the physiological dose, equivalent to 10 mg/day prednisone or its equivalent; (3) Steroids used as premedication for hypersensitivity reactions (e.g., premedication for CT scans). 8.Those with a history of substance abuse who are unable to quit, or those with mental disorders; 9.A history of or evidence of interstitial lung disease or active non-infectious pneumonia; 10.Receive a live attenuated vaccine within 30 days prior to the first dose of the study drug. Note: If enrolled, patients must not receive any live vaccines during treatment with the study drug or within 30 days after the last dose of the study drug; 11.Known history of allergic reactions or hypersensitivity to any investigational drug or any of its excipients; 12.Enroll in another clinical study at the same time, unless that study is an observational (non-interventional) clinical study or the follow-up phase of an interventional study; 13.The researchers determined other circumstances that made participants ineligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease control rate;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactWei Geng
Yancheng First People's Hospital
Outcome results
None listed