Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT05522894
Eligibility Criteria:
Inclusion Criteria:
1. Age: 18 to 75 years old, men or women are not limited
2. Histologically or cytologically confirmed as esophageal squamous cell carcinoma (including the gastroesophageal junction), (adenosquamous carcinoma with a predominantly squamous component is allowed)
3. Unresectable, locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma
4. Patients who have never received systemic antitumor therapy
5. ECOG score 0-1
6. Patients who have measurable lesions that meet RECIST 1.1 criteria
7. Patients who are expected to survive more than 3 months
8. Women of childbearing age must have a negative pregnancy test (serum or urine) and voluntarily use an appropriate method of contraception
9. Patients who are voluntarily enrolled in the study and sign an informed consent form (ICF)
10. Patients who are well adherent and able to follow up the study protocol
11. Patients with normal function organs, no serious abnormalities of blood, heart, lung, liver, kidney function, and immunodeficiency diseases.
12. Patients with normal coagulation function, no active bleeding, and thrombotic disease
13. cohort A: AK104 monotherapy cohort enrolling patients with esophageal cancer tumor tissue PD-L1 CPS ≥ 5 (uniformly using Dako 22C3 antibody)
Exclusion Criteria:
1. Locally advanced esophageal cancer that can be radically resectable or potentially cured by radiotherapy
2. Other malignancies diagnosed within 5 years prior to the first administration of the study drug, except effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or effectively resected in situ cervical and/or breast cancer
3. Symptomatic central nervous system metastases (brain metastases confirmed stable by imaging for more than 3 months can be enrolled)
4. A serious infection (CTCAE \> grade 2) such as severe pneumonia requiring hospitalization, bacteremia, or infectious comorbidities that occurred within 4 weeks prior to the first administration of the study drug; baseline chest imaging suggestive of active pulmonary inflammation with clinically relevant signs or symptoms; signs and symptoms of infection within 2 weeks prior to the first administration of study drug, or requiring oral, or intravenous antibiotic therapy. Excluding prophylactic use of antibiotics
5. Patients with previous and current interstitial pneumonia, pneumoconiosis, drug-related pneumonia, or severely impaired lung function that may interfere with the detection and management of suspected drug-related pulmonary toxicity; patients with radiation pneumonia within 6 months
6. Patients with active tuberculosis infection detected by history or CT examination, patients with a history of active tuberculosis infection within 1 year prior to enrollment, or patients with a history of active tuberculosis infection more than 1 year ago but without formal treatment
7. Patients previously treated with immune checkpoint inhibitors
8. Patients who have a congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (positive for hepatitis C antibodies and HCV-RNA above the lower limit of detection of the assay) or combined hepatitis B and hepatitis C co-infection
9. Patients who have a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
10. The presence of thrombosis-type diseases or using anticoagulant drugs
11. Patients with any serious or uncontrolled systemic disease that, in the opinion of the investigator, may increase the risk associated with participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05522894
Study Brief:
Protocol Section:
NCT05522894