Esophageal squamous carcinoma
Conditions
Interventions
Sponsors
Yancheng First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years, gender unrestricted; 2.Histologically or cytologically confirmed esophageal squamous cell carcinoma; 3.Previous systemic therapy (only second-line subjects can be enrolled); 4.ECOG PS 0-1; 5.At least one measurable lesion (according to RECIST 1.1); 6.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 calculated creatinine clearance > 60 mL/min using the Cockcroft-Gault formula (using actual body weight): for men: creatinine clearance = (weight x (140 - age)) / (72 x serum creatinine); for women: creatinine clearance = (weight x (140 - age)) / (72 x serum creatinine) x 0.85, where CL = mL/min; serum creatinine = mg/dL; 7.Patients with active HBV infection should have received antiviral treatment for more than 2 weeks according to local antiviral treatment guidelines before enrollment and should continue treatment for 6 months after study drug administration; 8.Negative HCV antibody test at screening, or positive HCV antibody test at screening but negative HCV RNA test subsequently; 9.Expected survival >= 12 weeks; 10.Patients have signed the informed consent form and voluntarily join this study.
Exclusion criteria
Exclusion criteria: 1.Have a high risk of esophageal fistula, such as a history of esophageal fistula or related symptoms, or the primary tumor has infiltrated major blood vessels or the trachea; 2.Evidence of complete esophageal obstruction, unsuitable for treatment; 3.Active or previously recorded autoimmune diseases or inflammatory disorders (including inflammatory bowel disease [such as colitis or Crohn's disease], diverticulitis (except diverticulosis), systemic lupus erythematosus, sarcoidosis syndrome or Wegener's syndrome [granulomatous polyangiitis, Graves' disease, rheumatoid arthritis, pituitary inflammation and uveitis, etc.]); The following are the exceptions to this standard: (1) patients with vitiligo or alopecia; (2) patients with hypothyroidism (such as Hashimoto's syndrome) who are receiving stable hormone replacement therapy; (3) any chronic skin disease that does not require systemic treatment; (4) patients who can be included within the past 5 years without active disease, but only after consultation with the research physician; (5) patients with celiac disease that can be controlled by diet alone; 4.Active infection, including tuberculosis (clinical evaluation includes clinical history, physical examination, imaging results and tuberculosis examination in accordance with local treatment principles); 5.Uncontrolled complications, including but not limited to persistent infection or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, severe chronic gastrointestinal disease accompanied by diarrhea, or conditions that limit the study's compliance requirements, significantly increase the risk of AE occurrence or impair the patient's ability to provide written informed consent; 6.Previous thyroid dysfunction, and in the case of drug treatment, the thyroid function still cannot be maintained within the normal range; 7.Within 14 days before the first administration of QL1706, using immunosuppressive drugs currently or previously. The following are the exceptions to this standard: (1) intranasal, inhalation, topical steroids or local injections of steroids (such as intra-articular injection); (2) no more than the physiological dose of systemic glucocorticoids, equivalent to 10 mg/day prednisone or its equivalent; (3) steroid hormones as pre-treatment medication for hypersensitivity reactions (such as CT scan pre-treatment medication); 8.Those with a history of substance abuse of psychotropic drugs and unable to quit or with mental disorders; 9.Known history of interstitial lung disease or active non-infectious pneumonia or evidence thereof; 10.Within 30 days before the first administration of the study drug, received live attenuated vaccines. Note: If selected, patients shall not receive live vaccines during the study drug treatment and within 30 days after the last administration of the study drug; 11.Known to have allergic reactions or hypersensitivity reactions to any study drug or its excipients; 12.Enrolled in another clinical study at the same time, unless the study is an observational (non-interventional) clinical study or the follow-up period of an intervention study; 13.The investigator determines other circumstances that are not suitable for inclusion in the study. 14.Previous use of QL1706 or other PD-1/CTLA-4 bispecific antibodies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response;Safety;Disease Control Rate;Overall Survival ;Progression-Free Survival ; | — |
Countries
China
Contacts
Public ContactXichao Dai
Yancheng First People's Hospital
Outcome results
None listed