Esophageal squamous cell carcinoma
Conditions
Interventions
Experimental Group:The treatment regimen consists of QL1706 (5 mg/kg, intravenous infusion, every 3 weeks) in combination with anlotinib (12 mg, orally once daily on days 1-14, every 3 weeks). Treatme
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Participants voluntarily participate in the study and provide signed informed consent. 2. Aged 18 to 75 years old, regardless of gender. 3. Histologically or cytologically confirmed unresectable locally advanced, locally recurrent (including regional lymph node metastasis) or distant metastatic esophageal squamous cell carcinoma (ESCC). 4. Documented disease progression by imaging following standard first-line anti-PD-(L)1 immunotherapy. 5. At least one measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 7. Life expectancy of at least 3 months. 8. Adequate organ function, as defined by the following laboratory parameters (no administration of blood products [e.g., albumin], growth factors, or other corrective therapies within 14 days prior to the first study dose): Hemoglobin >= 90 g/L Absolute neutrophil count (ANC)>= 1.5 × 10^9/L Platelet count >= 60 × 10^9/L Serum albumin >= 30 g/L Total bilirubin 2000 copies/mL, stable oral antiviral therapy must have been initiated for at least 1 week prior to study enrollment 9. Agree to use effective contraception from the date of informed consent signing until 120 days after the last dose of study medication.
Exclusion criteria
Exclusion criteria: 1. Known esophageal squamous cell carcinoma (ESCC) with an endoscopic tendency to cause complete obstruction, requiring interventional procedures for obstruction relief. 2. History of esophageal or tracheal stent implantation; patients with tumors significantly invading adjacent organs (aorta or trachea) with a high risk of bleeding or perforation; or presence of fistulas. 3. History of other malignant diseases diagnosed within 3 years prior to the first study dose, except for radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ. 4. Active autoimmune disease requiring systemic treatment within 2 years prior to the first study dose (e.g., disease-modifying agents, systemic corticosteroids, or immunosuppressants). Replacement therapy (e.g., thyroxine for hypothyroidism, insulin for diabetes mellitus, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic treatment. 5. Known history of allogeneic organ transplantation (corneal transplantation excluded) or allogeneic hematopoietic stem cell transplantation. 6. Failure to fully recover from toxicities and/or complications caused by prior interventions to = Grade 1 or baseline levels prior to treatment initiation, except for alopecia or fatigue. 7. Prior receipt of any of the following treatments: (1)Systemic anti-tumor therapy (e.g., chemotherapy, targeted therapy, immunotherapy, or traditional Chinese medicine with anti-tumor intent) within 3 weeks prior to treatment initiation. (2) Investigational drug therapy within 4 weeks prior to treatment initiation. (3) Systemic administration of excessive immunosuppressive agents within 4 weeks prior to treatment initiation (systemic corticosteroids at doses exceeding 10 mg/day of prednisone or its equivalent). (4) Administration of live attenuated vaccines within 4 weeks prior to treatment initiation, or planned receipt of such vaccines during the study period. (5) Major surgery, or presence of unhealed surgical wounds, ulcers, or fractures within 4 weeks prior to treatment initiation. 8. Unresolved toxicities and/or complications from prior interventions (not recovered to <= Grade 1 or baseline) prior to treatment initiation, excluding fatigue and alopecia. 9. Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1/2 antibodies). 10. Untreated active hepatitis B (defined as HBsAg-positive with HBV-DNA copy number exceeding the upper limit of normal [ULN] at the central laboratory). 11. Note: Subjects with hepatitis B may be eligible if they meet the following criteria: (1) HBV viral load < 1000 copies/mL (200 IU/mL) prior to the first study dose; subjects must receive continuous anti-HBV therapy throughout the study treatment period to prevent viral reactivation. (2) Subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load undetectable do not require prophylactic anti-HBV therapy but must undergo close monitoring for viral reactivation. 12. Active hepatitis C virus (HCV) infection (HCV antibody-positive with HCV-RNA level above the lower limit of detection). 13. Current pregnancy or lactation. 14. Presence of severe or uncontrolled systemic diseases, including but not limited to: (1) Significant cardiac rhythm, conduction, or morphological abnormalities on resting electrocardiogram (ECG), such as complete left bundle branch block, second-degree or higher atrioventricular block, ventricul
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;One-Year Survival Rate ;Disease control rate,DCR; | — |
Countries
China
Contacts
Public ContactLv Hongying
The Affiliated Hospital of Qingdao University
Outcome results
None listed