Gastric/Gastroesophageal Junction Adenocarcinoma
Conditions
Interventions
Experimental group:QL1706+chemotherapy
Sponsors
Subei People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients must voluntarily enroll in this study and sign an informed consent form; 2.Male or female, age >= 18 years; 3.ECOG performance status score 0-2; 4.Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma; 5.Clinical staging based on contrast-enhanced CT/MRI scans (combined with endoscopic ultrasound and diagnostic laparoscopy if necessary) shows stage III-IV disease (AJCC 8th edition TNM staging for gastric cancer) that is unresectable locally advanced or metastatic; eligibility for radical surgery is determined by multidisciplinary team (MDT) discussion; 6.Must have received at least one prior line of systemic therapy; 7.Estimated life expectancy >= 3 months. 8.Have at least one measurable lesion according to RECIST 1.1 criteria; 9.Subjects must have baseline hematology and biochemistry parameters meeting the following criteria (no blood transfusion or blood products, and no use of G-CSF or other hematopoietic growth factors for correction within 14 days prior to first dose): Hemoglobin >= 90 g/L; Absolute neutrophil count (ANC) >= 1.5×10^9/L; Platelets >= 80×10^9/L; ALT, AST 50 ml/min (Male: creatinine clearance = ((140-age) × weight)/(72×serum Cr); Female: creatinine clearance = ((140-age) × weight)/(72×serum Cr) × 0.85; weight unit: kg; serum Cr unit: mg/mL); Serum albumin >= 30 g/L. 10.Patients must have good compliance and be able to follow the protocol during the study period; 11.Female subjects of childbearing potential must undergo a serum pregnancy test within 72 hours prior to the first dose of the study drug and have a negative result, and agree to use highly effective contraception during the study treatment period and for 90 days after the end of treatment; male subjects whose partners are women of childbearing potential must agree to use highly effective contraception during the treatment period and for 90 days after the end of treatment.
Exclusion criteria
Exclusion criteria: 1.Known HER2-positive (HER2-positive is defined as IHC 3+ or IHC 2+/ISH+); 2.History of other malignant diseases within the past 5 years or concurrent malignancy, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ; 3.Prior history of gastrointestinal perforation, abdominal abscess, or intestinal obstruction within the past 3 months, or imaging/clinical symptoms suggestive of intestinal obstruction; 4.Patients requiring immunosuppressive therapy for organ transplantation; patients who have used immunosuppressive drugs or systemic corticosteroids for immunosuppressive purposes within 14 days before treatment (e.g., prednisone >10 mg/day or equivalent dose of other drugs); 5.Known hypersensitivity to any investigational drug or excipient; 6.Active hepatitis (Hepatitis B reference: HBsAg positive with HBV DNA >=500 IU/mL; Hepatitis C reference: HCV antibody positive with HCV viral load > upper limit of normal); patients in active infection stage requiring antimicrobial therapy (e.g., antibacterial or antifungal therapy); 7.Currently with interstitial pneumonitis or interstitial lung disease, or other conditions that may interfere with assessment and management of immune-related pulmonary toxicity, including pulmonary fibrosis, organizing pneumonia, pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or active pneumonia or severe pulmonary function impairment shown on screening CT; patients with active pulmonary tuberculosis; 8.Patients with active autoimmune disease or history of autoimmune disease with potential for recurrence (including but not limited to immune hepatitis, interstitial pneumonitis, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects controllable by hormone replacement therapy may be included]); skin diseases not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia), Type I diabetes controllable by insulin therapy, or childhood asthma that has completely resolved without intervention may be enrolled; patients with asthma requiring bronchodilator intervention cannot be enrolled; 9.In the investigator's judgment, subjects have other factors that may affect trial results or cause early termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, severe laboratory abnormalities, or family/social factors that may affect patient safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate ;Progression-Free Survival;Overall Survival ; | — |
Countries
China
Contacts
Public ContactZhang Xianwen
Subei People's Hospital
Outcome results
None listed